#510(k) clearance

[sigmabiomedical]

510(k) Clearance vs. FDA Approval: What’s the Difference?

Navigating the regulatory landscape for medical devices can be daunting for manufacturers and developers. One of the key aspects of this landscape is understanding the difference between 510(k) clearance and FDA approval. Both are critical processes for bringing medical devices to market in the United States, but they serve different purposes and involve distinct pathways. This blog will explore these differences, providing insight into regulatory consulting for 510(k) submissions and the role of medical device 510(k) consulting in ensuring compliance.

Understanding the FDA's Role

The U.S. Food and Drug Administration (FDA) is the regulatory authority responsible for overseeing the safety and effectiveness of medical devices. The FDA categorizes medical devices based on their risk levels, which determines the regulatory pathway that must be followed before a device can be marketed.

The FDA's Device Classification System

Medical devices are classified into three categories:

Class I: Low-risk devices that are subject to the least regulatory control. These devices often require only general controls to ensure safety and effectiveness.

Class II: Moderate-risk devices that must comply with specific performance standards and typically require a 510(k) submission for clearance.

Class III: High-risk devices that require premarket approval (PMA) because they pose a greater risk to patients. This pathway is more rigorous than the 510(k) process.

What is 510(k) Clearance?

A 510(k) submission is a premarket notification that demonstrates a device is substantially equivalent to a device already on the market (known as a predicate device). The primary goal of the 510(k) process is to ensure that new devices do not introduce new safety or effectiveness concerns.

Key Aspects of 510(k) Clearance

Substantial Equivalence: To obtain 510(k) clearance, manufacturers must provide evidence that their device is as safe and effective as an existing device. This often involves comparing design, materials, and intended use.

Review Process: The FDA typically reviews 510(k) submissions within 90 days, although this timeline can vary based on the complexity of the device and the submission quality.

Documentation: A successful 510(k) submission requires thorough documentation, including data from preclinical and clinical studies, manufacturing processes, labeling, and more.

Role of Regulatory Consulting for 510(k)

Given the complexities involved in preparing a 510(k) submission, many manufacturers turn to regulatory consulting for 510(k). These consultants provide expertise in navigating the regulatory environment, helping to prepare comprehensive submissions that meet FDA requirements.

Guidance on Documentation: Consultants can guide manufacturers in gathering and presenting the necessary documentation, ensuring that the submission is complete and robust.

Predicates Identification: Finding appropriate predicate devices is critical for demonstrating substantial equivalence. Regulatory consultants help identify and evaluate these predicates.

Risk Assessment: Consultants can assist in assessing the risks associated with the device and developing strategies to mitigate them.

What is FDA Approval?

FDA approval, particularly for Class III devices, involves a more rigorous evaluation process known as premarket approval (PMA). Unlike the 510(k) process, PMA requires comprehensive scientific evidence to demonstrate a device's safety and effectiveness.

Key Aspects of FDA Approval

Extensive Testing: The PMA process often requires extensive clinical trials and testing to provide data on safety and effectiveness. This can be a time-consuming and costly endeavor.

Longer Review Process: The FDA may take several months to years to review a PMA application, depending on the complexity of the device and the quality of the submitted data.

Post-Market Surveillance: Approved devices are often subject to post-market surveillance to monitor their performance and safety in real-world settings.

Key Differences Between 510(k) Clearance and FDA Approval

Purpose:

510(k): Demonstrates substantial equivalence to a predicate device.

FDA Approval: Establishes safety and effectiveness through extensive data and testing.

Timeframe:

510(k): Typically reviewed within 90 days.

FDA Approval: May take several months to years.

Data Requirements:

510(k): Requires less extensive data; relies on comparison with existing devices.

FDA Approval: Requires comprehensive scientific evidence, including clinical trials.

Class of Device:

510(k): Generally for Class II devices.

FDA Approval: Primarily for Class III devices.

Conclusion

Understanding the differences between 510(k) clearance and FDA approval is crucial for medical device manufacturers seeking to bring their products to market. While both processes are essential for ensuring the safety and effectiveness of medical devices, they serve distinct roles within the regulatory framework. Engaging in medical device 510(k) consulting can significantly enhance the chances of a successful submission, allowing manufacturers to navigate the complexities of the regulatory landscape efficiently. By leveraging the expertise of regulatory consultants, companies can ensure compliance and focus on what matters most: delivering safe and effective devices to patients.

[elexes]

Once a new medical device is in the market through a 510(k) clearance, it’s critical to continue monitoring changes to that device throughout its lifecycle and evaluating if any of these changes trigger a new 510(k) for the medical device.

[latestmarketresearchnews]

In Vitro Diagnostics (IVD) Industry Sales, Demand, Regional Outlook And Supply Chain Analysis till 2030

The global in vitro diagnostics (IVD) market reached an estimated size of USD 77.92 billion in 2023, with expectations for a compound annual growth rate (CAGR) of 4.4% from 2024 to 2030. This market growth is primarily driven by the increasing use of IVD tools due to rising cases of infectious and chronic diseases worldwide. Automated IVD systems are becoming more common in hospitals and laboratories, as they provide accurate, fast, and error-free diagnoses, helping meet the growing demand for efficient healthcare services. Additionally, IVD market expansion is fueled by frequent product launches from key industry players. For example, in November 2023, ARUP Laboratories received a CE mark from the EU-IVDR for AAV5 DetectCDx, a companion diagnostic that helps identify eligibility for severe hemophilia Some patients to receive BioMarin’s gene therapy, Roctavian.

Major companies in the IVD market are employing various strategies to strengthen their position and bring more advanced and diverse products to their customers. New product launches and partnerships are among the most common tactics. For instance, in March 2023, BD received FDA 510(k) clearance for the BD Vaginal Panel on its BD COR System, a tool designed to detect infectious causes of vaginitis. In another instance, in August 2023, the Precision Medicine Centre (PMC) partnered with the Regional Molecular Diagnostic Service (RMDS) to implement genomic technology for cancer diagnosis in Northern Ireland. These partnerships and product developments highlight how key players are focused on expanding their diagnostic offerings to meet growing healthcare needs.

Gather more insights about the market drivers, restrains and growth of the In Vitro Diagnostics (IVD) Market

Supportive initiatives from government and non-governmental bodies are also contributing to the market's growth by enhancing access to essential diagnostic tools. In October 2023, the World Health Organization (WHO) released an updated Essential Diagnostics List (EDL), a comprehensive catalog of vital IVD products that aids countries in making informed decisions on diagnostic tools. This list provides evidence-based recommendations, ensuring that essential diagnostic products are accessible to the people who need them most. Additionally, in August 2023, the Africa CDC collaborated with the Africa Development Agency-New Partnership for Africa's Development (AUDA-NEPAD) to improve access to diagnostic tests across the African continent. Such initiatives are expected to further support the expansion of the IVD market, especially in regions with limited healthcare resources.

The global aging population, coupled with growing awareness of early disease detection, has led to an increase in routine check-ups. This trend is particularly relevant because the majority of deaths due to infections and chronic conditions occur in people over 75. According to the UK's Office for Budget Responsibility, healthcare costs have seen a significant rise, which can place economic strain on countries with rapidly aging populations. However, these increased expenditures are likely to boost the IVD market, as diagnostic testing becomes essential in managing the healthcare needs of older adults.

End-use Segmentation Insights:

Hospitals represented the largest revenue share in the IVD market in 2023, largely due to an increase in hospital admissions requiring rapid diagnostic support. The continuous development of healthcare infrastructure, supported by government initiatives, is further improving hospital facilities, thereby increasing demand for hospital-based IVD testing. IVD tests are frequently purchased by hospitals and are utilized in large volumes due to their critical role in providing fast, accurate results for patient care. In the U.S. alone, there are over 6,129 hospitals, all of which rely on IVD tests for essential decision-making in patient care.

In December 2023, the American Hospital Association advocated to the FDA that regulatory requirements for devices should not apply to hospitals' laboratory-developed tests (LDTs), which could allow hospitals greater flexibility in their use of in-house diagnostic tools. Meanwhile, the homecare segment is anticipated to see high growth from 2024 to 2030, driven by the aging population and increasing demand for at-home diagnostic devices. There is a particular need for novel molecular diagnostic and immunoassay platforms that enable patients to perform self-tests conveniently at home. For example, in February 2023, the FDA granted Emergency Use Authorization (EUA) to the first over-the-counter (OTC) home diagnostic test capable of distinguishing between influenza A, influenza B, and SARS-CoV-2 (the virus causing COVID-19). This authorization demonstrates the shift towards providing individuals with more autonomy in managing their health through accessible at-home testing solutions.

Order a free sample PDF of the In Vitro Diagnostics (IVD) Market Intelligence Study, published by Grand View Research.

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In Vitro Diagnostics (IVD) Industry Growth Analysis & Forecast Research Report, 2030

The global in vitro diagnostics (IVD) market reached an estimated size of USD 77.92 billion in 2023, with expectations for a compound annual growth rate (CAGR) of 4.4% from 2024 to 2030. This market growth is primarily driven by the increasing use of IVD tools due to rising cases of infectious and chronic diseases worldwide. Automated IVD systems are becoming more common in hospitals and laboratories, as they provide accurate, fast, and error-free diagnoses, helping meet the growing demand for efficient healthcare services. Additionally, IVD market expansion is fueled by frequent product launches from key industry players. For example, in November 2023, ARUP Laboratories received a CE mark from the EU-IVDR for AAV5 DetectCDx, a companion diagnostic that helps identify eligibility for severe hemophilia Some patients to receive BioMarin’s gene therapy, Roctavian.

Major companies in the IVD market are employing various strategies to strengthen their position and bring more advanced and diverse products to their customers. New product launches and partnerships are among the most common tactics. For instance, in March 2023, BD received FDA 510(k) clearance for the BD Vaginal Panel on its BD COR System, a tool designed to detect infectious causes of vaginitis. In another instance, in August 2023, the Precision Medicine Centre (PMC) partnered with the Regional Molecular Diagnostic Service (RMDS) to implement genomic technology for cancer diagnosis in Northern Ireland. These partnerships and product developments highlight how key players are focused on expanding their diagnostic offerings to meet growing healthcare needs.

Gather more insights about the market drivers, restrains and growth of the In Vitro Diagnostics (IVD) Market

Supportive initiatives from government and non-governmental bodies are also contributing to the market's growth by enhancing access to essential diagnostic tools. In October 2023, the World Health Organization (WHO) released an updated Essential Diagnostics List (EDL), a comprehensive catalog of vital IVD products that aids countries in making informed decisions on diagnostic tools. This list provides evidence-based recommendations, ensuring that essential diagnostic products are accessible to the people who need them most. Additionally, in August 2023, the Africa CDC collaborated with the Africa Development Agency-New Partnership for Africa's Development (AUDA-NEPAD) to improve access to diagnostic tests across the African continent. Such initiatives are expected to further support the expansion of the IVD market, especially in regions with limited healthcare resources.

The global aging population, coupled with growing awareness of early disease detection, has led to an increase in routine check-ups. This trend is particularly relevant because the majority of deaths due to infections and chronic conditions occur in people over 75. According to the UK's Office for Budget Responsibility, healthcare costs have seen a significant rise, which can place economic strain on countries with rapidly aging populations. However, these increased expenditures are likely to boost the IVD market, as diagnostic testing becomes essential in managing the healthcare needs of older adults.

End-use Segmentation Insights:

Hospitals represented the largest revenue share in the IVD market in 2023, largely due to an increase in hospital admissions requiring rapid diagnostic support. The continuous development of healthcare infrastructure, supported by government initiatives, is further improving hospital facilities, thereby increasing demand for hospital-based IVD testing. IVD tests are frequently purchased by hospitals and are utilized in large volumes due to their critical role in providing fast, accurate results for patient care. In the U.S. alone, there are over 6,129 hospitals, all of which rely on IVD tests for essential decision-making in patient care.

In December 2023, the American Hospital Association advocated to the FDA that regulatory requirements for devices should not apply to hospitals' laboratory-developed tests (LDTs), which could allow hospitals greater flexibility in their use of in-house diagnostic tools. Meanwhile, the homecare segment is anticipated to see high growth from 2024 to 2030, driven by the aging population and increasing demand for at-home diagnostic devices. There is a particular need for novel molecular diagnostic and immunoassay platforms that enable patients to perform self-tests conveniently at home. For example, in February 2023, the FDA granted Emergency Use Authorization (EUA) to the first over-the-counter (OTC) home diagnostic test capable of distinguishing between influenza A, influenza B, and SARS-CoV-2 (the virus causing COVID-19). This authorization demonstrates the shift towards providing individuals with more autonomy in managing their health through accessible at-home testing solutions.

Order a free sample PDF of the In Vitro Diagnostics (IVD) Market Intelligence Study, published by Grand View Research.

[drcare4u]

Exactech Announces FDA Clearance of Truliant® Porous 3D Tibial Implant for Knee Replacement Surgery

GAINESVILLE, Fla., Oct. 31, 2024 /PRNewswire/ — Exactech, a global medical technology leader, announced today it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Truliant® Porous Tibial Tray, a 3D tibial knee implant. The Truliant Porous Tibial Tray leverages additive manufacturing technology to create a porous structure designed to mimic the structure of…

[marketanalysisdata]

In Vitro Diagnostics (IVD) Industry Size, Trends, Value, Sales and Forecast 2030

The global in vitro diagnostics (IVD) market was valued at approximately USD 77.92 billion in 2023 and is projected to grow at a compound annual growth rate (CAGR) of 4.4% from 2024 to 2030. This growth can be attributed to several factors, including the increasing adoption of IVD technologies due to the rising prevalence of infectious and chronic diseases. The development and integration of automated IVD systems in laboratories and hospitals, which aim to deliver more efficient, accurate, and error-free diagnoses, are also expected to significantly drive market growth. Additionally, the continuous introduction of new IVD products by key industry players contributes to this positive trend. For instance, in November 2023, ARUP Laboratories obtained a CE mark under the EU-IVDR for the AAV5 DetectCDx, a companion diagnostic test that determines the eligibility of patients with severe hemophilia A for BioMarin's gene therapy, Roctavian.

Technological advancements in IVD systems, particularly improvements in accuracy, portability, and cost-effectiveness, are among the high-impact factors influencing this market. Innovations in highly accurate clinical laboratory tests are fostering global adoption of novel IVD diagnostics. For example, in June 2023, Japan's Ministry of Health, Labour, and Welfare granted marketing approval to Toray Industries, Inc. for its Toray APOA2-iTQ, a diagnostic tool used for pancreatic cancer detection. Similarly, in March 2023, Abbott received U.S. FDA clearance for its novel laboratory blood test for Traumatic Brain Injury (TBI). These developments highlight the increasing approval of IVD tests targeting life-threatening diseases, which is expected to create significant opportunities in untapped market segments.

Gather more insights about the market drivers, restrains and growth of the In Vitro Diagnostics (IVD) Market

Leading companies in the IVD market are adopting diverse strategies to strengthen their positions, often introducing new products and forming partnerships to attract more customers and meet evolving diagnostic needs. For instance, in March 2023, BD received 510(k) clearance from the U.S. FDA for its BD Vaginal Panel on the BD COR System, aimed at detecting infectious causes of vaginitis. In August 2023, the Precision Medicine Centre (PMC) partnered with the Regional Molecular Diagnostic Service (RMDS) to implement genomic technology for cancer diagnosis in Northern Ireland. These strategic collaborations and product launches are critical for companies seeking to leverage cutting-edge technologies in diagnostics.

Product Segmentation Insights:

In terms of products, the reagents segment accounted for the largest market share, representing 65.88% of total revenue in 2023. This segment is expected to maintain its dominance, growing at the fastest CAGR from 2024 to 2030. The growth of the reagents segment is driven by extensive research and development (R&D) efforts by key players aimed at developing novel reagents and test kits. For example, in February 2023, BD received market approval for its BD Onclarity HPV Assay, which is used with the ThinPrep Pap Test in the U.S. Ongoing R&D efforts focused on faster cancer detection and precision medicine are prompting companies to concentrate on specialized, profitable areas of the IVD market. In March 2023, QIAGEN formed a partnership with Servier to develop a companion diagnostic test for TIBSOVO, which is indicated for the treatment of acute myeloid leukemia, a type of blood cancer.

The growing demand for precision medicine is expected to further boost the overall demand for these novel reagents and consumables. The instruments segment held the second-largest share of the IVD market in 2023. Increasing approvals of novel IVD instruments are likely to contribute to the segment's growth. For instance, in April 2023, bioMérieux SA submitted a 510(k) application to the U.S. FDA for VITEK REVEAL, a rapid antimicrobial susceptibility testing (AST) system. Moreover, companies are aligning their instrument launches to meet the increasing demand for genetic tests globally. In March 2022, Thermo Fisher Scientific introduced the Ion Torrent Genexus Dx Integrated Sequencer for both research and diagnostic purposes, showcasing the alignment of technological advancements with the growing needs of genetic testing.

In conclusion, the global IVD market is poised for substantial growth, driven by the increasing incidence of infectious and chronic diseases, rising demand for precision medicine, and ongoing advancements in diagnostic technologies. Companies are continuously innovating, launching new products, and forming strategic partnerships to meet the evolving needs of healthcare providers and patients, which will further accelerate market expansion.

Order a free sample PDF of the In Vitro Diagnostics (IVD) Market Intelligence Study, published by Grand View Research.

[marketstudyreport]

In Vitro Diagnostics (IVD) Market Growth Analysis & Forecast Research Report, 2030

The global in vitro diagnostics (IVD) market was valued at approximately USD 77.92 billion in 2023 and is projected to grow at a compound annual growth rate (CAGR) of 4.4% from 2024 to 2030. This growth can be attributed to several factors, including the increasing adoption of IVD technologies due to the rising prevalence of infectious and chronic diseases. The development and integration of automated IVD systems in laboratories and hospitals, which aim to deliver more efficient, accurate, and error-free diagnoses, are also expected to significantly drive market growth. Additionally, the continuous introduction of new IVD products by key industry players contributes to this positive trend. For instance, in November 2023, ARUP Laboratories obtained a CE mark under the EU-IVDR for the AAV5 DetectCDx, a companion diagnostic test that determines the eligibility of patients with severe hemophilia A for BioMarin's gene therapy, Roctavian.

Technological advancements in IVD systems, particularly improvements in accuracy, portability, and cost-effectiveness, are among the high-impact factors influencing this market. Innovations in highly accurate clinical laboratory tests are fostering global adoption of novel IVD diagnostics. For example, in June 2023, Japan's Ministry of Health, Labour, and Welfare granted marketing approval to Toray Industries, Inc. for its Toray APOA2-iTQ, a diagnostic tool used for pancreatic cancer detection. Similarly, in March 2023, Abbott received U.S. FDA clearance for its novel laboratory blood test for Traumatic Brain Injury (TBI). These developments highlight the increasing approval of IVD tests targeting life-threatening diseases, which is expected to create significant opportunities in untapped market segments.

Gather more insights about the market drivers, restrains and growth of the In Vitro Diagnostics (IVD) Market

Leading companies in the IVD market are adopting diverse strategies to strengthen their positions, often introducing new products and forming partnerships to attract more customers and meet evolving diagnostic needs. For instance, in March 2023, BD received 510(k) clearance from the U.S. FDA for its BD Vaginal Panel on the BD COR System, aimed at detecting infectious causes of vaginitis. In August 2023, the Precision Medicine Centre (PMC) partnered with the Regional Molecular Diagnostic Service (RMDS) to implement genomic technology for cancer diagnosis in Northern Ireland. These strategic collaborations and product launches are critical for companies seeking to leverage cutting-edge technologies in diagnostics.

Product Segmentation Insights:

In terms of products, the reagents segment accounted for the largest market share, representing 65.88% of total revenue in 2023. This segment is expected to maintain its dominance, growing at the fastest CAGR from 2024 to 2030. The growth of the reagents segment is driven by extensive research and development (R&D) efforts by key players aimed at developing novel reagents and test kits. For example, in February 2023, BD received market approval for its BD Onclarity HPV Assay, which is used with the ThinPrep Pap Test in the U.S. Ongoing R&D efforts focused on faster cancer detection and precision medicine are prompting companies to concentrate on specialized, profitable areas of the IVD market. In March 2023, QIAGEN formed a partnership with Servier to develop a companion diagnostic test for TIBSOVO, which is indicated for the treatment of acute myeloid leukemia, a type of blood cancer.

The growing demand for precision medicine is expected to further boost the overall demand for these novel reagents and consumables. The instruments segment held the second-largest share of the IVD market in 2023. Increasing approvals of novel IVD instruments are likely to contribute to the segment's growth. For instance, in April 2023, bioMérieux SA submitted a 510(k) application to the U.S. FDA for VITEK REVEAL, a rapid antimicrobial susceptibility testing (AST) system. Moreover, companies are aligning their instrument launches to meet the increasing demand for genetic tests globally. In March 2022, Thermo Fisher Scientific introduced the Ion Torrent Genexus Dx Integrated Sequencer for both research and diagnostic purposes, showcasing the alignment of technological advancements with the growing needs of genetic testing.

In conclusion, the global IVD market is poised for substantial growth, driven by the increasing incidence of infectious and chronic diseases, rising demand for precision medicine, and ongoing advancements in diagnostic technologies. Companies are continuously innovating, launching new products, and forming strategic partnerships to meet the evolving needs of healthcare providers and patients, which will further accelerate market expansion.

Order a free sample PDF of the In Vitro Diagnostics (IVD) Market Intelligence Study, published by Grand View Research.

[tamanna31]

Exoskeleton Market Trends, Statistics, Segments, Graphs Growth Factors Forecast to 2030

 Exoskeleton Industry Overview

The global exoskeleton market size was estimated at USD 419.5 million in 2023 and is projected to grow at a compound annual growth rate (CAGR) of 16.6% from 2024 to 2030. In terms of volume, the market volume was 13,643 units in 2023 and is projected to grow at a CAGR of 9.3% from 2024 to 2030. Rapidly growing global geriatric population, rising adoption rates of medical devices in different industries such as automobile, military, defense, and construction, and rising incidence of stroke are some of the key driving forces responsible for the market growth.

Gather more insights about the market drivers, restrains and growth of the Exoskeleton Market

Furthermore, the growing incidence rate of spinal cord injuries (SCI) is expected to drive the demand across global markets. For instance, as per the National Spinal Cord Injury Statistical Center (NSCISC), in the U.S., 17,730 new SCIs are diagnosed annually, and approximately 291,000 live with SCIs.

Exoskeleton solutions are widely adopted across industries to support employee health and boost productivity. Growing demand has led to emergence of several startups expertizing in exoskeleton technology and providing solutions for rehabilitation. Furthermore, constantly evolving exoskeleton industry is driving market players to devise innovative product development strategies to boost adoption over the forecast period. For instance, in June 2022, Ekso Bionics received 510(k) FDA clearance for marketing the EksoNR robotic exoskeleton. It is the latest generation of devices that can be used for rehabilitation of multiple sclerosis patients.

Some of the most common musculoskeletal injuries and disorders affecting the construction industry are occupational overuse syndrome (OOS), cumulative trauma disorders (CTD), and repetitive strain injury (RSI). For instance, as per WHO data estimates published in July 2022, approximately 1.71 billion individuals across the globe have musculoskeletal disorders that include neck pain, lower back pain, fractures, amputation, rheumatoid arthritis, and osteoarthrit is. Similarly, in 2022, according to the U.S. Bureau of Labor Statistics, approximately 502,380 workers have occupation-related musculoskeletal disorders across several industries. These are some of the driving factors boosting adoption of exoskeleton solutions owing to benefits associated with exoskeleton technology, such as augmenting or assisting users’ physical activity or capability, improving users’ health & productivity, and reducing fatigue experienced by industrial workers.

Rapid technological advancements in the global market are expected to boost the demand for exoskeletons. Increasing popularity and growing adoption of exoskeletons by companies are expected to contribute to market growth. In addition, increasing adoption of exoskeletons in manufacturing sector, logistics, automotive, and construction is leading to a rise in penetration of exoskeletons, thereby fueling the market growth. For instance, in December 2021, IKEA and BMW are using Bionic’s fifth generation Cray X, an AI-enabled, powered exoskeleton capable of lifting an additional 70 pounds, reducing the risk of repetitive stress injuries and back injuries. Such advancements are expected to boost market growth over the forecast period.

Browse through Grand View Research's Medical Devices Industry Research Reports.

• The global disposable hospital gowns market size was valued at USD 3.68 billion in 2023 and is projected to grow at a CAGR of 12.9% from 2024 to 2030. The heightened focus on infection control within medical settings fuels the demand for disposable gowns.

• The global knee braces market size was valued at USD 1.12 billion in 2023 and is projected to grow at a CAGR of 7.7% from 2024 to 2030. The rise in osteoarthritis (OA) cases, orthopedic knee surgeries, athletic injuries and other knee related injuries are fueling the growth of the knee brace industry.

Exoskeleton Market Segmentation

Grand View Research, Inc. has segmented the exoskeleton market report based on mobility, technology, extremity, structure, end-use, and region:

Exoskeleton Mobility Outlook (Volume, Revenue, USD Million, 2018 - 2030) • Mobile • Fixed/Stationary

Exoskeleton Technology Outlook (Volume, Revenue, USD Million, 2018 - 2030) • Powered • Non-powered

Exoskeleton Extremity Outlook (Volume, Revenue, USD Million, 2018 - 2030) • Upper Body • Lower Body • Full Body

Exoskeleton Structure Outlook (Volume, Revenue, USD Million, 2018 - 2030) • Rigid Exoskeletons • Soft Exoskeletons

Exoskeleton End-Use Outlook (Volume, Revenue, USD Million, 2018 - 2030) • Healthcare • Military • Industry

Exoskeleton Regional Outlook (Volume, Revenue, USD Million, 2018 - 2030) • North America o US o Canada • Europe o Germany o UK o Spain o Italy o France o Denmark o Norway o Sweden • Asia Pacific o Japan o China o India o Australia o Thailand o South Korea • Latin America o Brazil o Mexico o Argentina • MEA o South Africa o Saudi Arabia o UAE o Kuwait

Key Companies profiled: • Ekso Bionics • Hocoma • Lockheed Martin Corporation • Suit X • Rex Bionics Plc. • RB3D • ReWalk Robotics • Cyberdyne, Inc. • ActiveLink (Panasonic Corporation)

Order a free sample PDF of the Exoskeleton Market Intelligence Study, published by Grand View Research.

Key Exoskeleton Company Insights

• Ekso Bionics specializes in bionic exoskeletons, robotics, and rehabilitation. Ekso Bionics received its first FDA clearance for exoskeleton for patients affected with spinal cord injuries and stroke. The company is a leader in technology innovation and is one of pioneers in the market. The company also focuses on partnering with established healthcare facilities to expand their distribution channels and enhance care delivery in newer business geographies

• Cyberdyne, Inc. develops and distributes exoskeleton suits widely used in medicine, caregiving, and living & labor support. The company has been devising various business expansion strategies such as mergers and technological collaborations. The company focuses on collaborating with different stakeholders of the supply chain, thereby increasing its clientele and expanding their business geography

• Lockheed Martin Corporation is a large company dealing in aerospace, security, defense, and other technologies. The company has expertise in developing exoskeleton or exo-robots for the military and defense industries. The company focuses on obtaining defense service contracts

Recent Developments

• In December 2023, German Bionic introduced the Apogee exoskeleton with robotic motors for healthcare workers to lift and move heavy patients with greater ease, less strain, and improved stamina

• In June 2022, CYBERDYNE Inc. formed a business and capital alliance with LIFESCAPES Inc. This collaboration highlighted the combined effort to further leverage the exoskeleton technology arena and improve rehabilitation options for patients with severe paralysis

• In June 2022, Ekso Bionics received 510(k) FDA clearance for marketing the EksoNR robotic exoskeleton. It is the latest generation of devices that can be used for the rehabilitation of multiple sclerosis patients

• In February 2020, Ekso Bionics launched EksoPulse platform, a cloud-deployed platform to measure and analyze EksoNR robotic exoskeleton. The platform is integrated with a user-friendly interface and dashboard to measure activity & progress in rehabilitation sessions

• In November 2018, Lockheed Martin received a USD 6.9 million development contract from the U.S. Army Natick Soldier Research, Development, and Engineering Center (NSRDEC) to further develop the Onyx exoskeleton for soldier demonstrations

[rudrasurgicals02]

Key Regulations Followed By Laparoscopic Instruments Manufacturer In India

Laparoscopic instrument manufacturers must adhere to stringent regulations to ensure the safety, effectiveness, and quality of their products. These regulations are enforced by various national and international health authorities to ensure that laparoscopic devices meet medical standards for patient safety. Here are some of the key regulations followed by Laparoscopic Instruments Manufacturer In India:

1. ISO Standards for Quality Management

ISO 13485 Certification: This is the internationally recognized standard for quality management systems specific to medical device manufacturers. It ensures that laparoscopic instruments are designed, developed, and manufactured under stringent quality controls.

ISO 14971 – Risk Management: Manufacturers must comply with this standard to manage the risks associated with the design and production of laparoscopic instruments. This includes risk identification, analysis, and mitigation throughout the product lifecycle.

2. FDA (Food and Drug Administration) Regulations

FDA 21 CFR Part 820 – Quality System Regulation (QSR): Manufacturers selling in the U.S. must comply with the FDA’s QSR, which outlines requirements for designing, manufacturing, packaging, and distributing medical devices.

Premarket Approval (PMA): For certain Class III medical devices, manufacturers must obtain FDA approval through the PMA process, demonstrating the safety and effectiveness of the laparoscopic instruments before they can be marketed.

510(k) Clearance: Many laparoscopic instruments fall under Class II devices, requiring manufacturers to submit a 510(k) premarket notification to the FDA. This process requires proving that the new device is substantially equivalent to an already legally marketed device.

3. CE Marking and European Union Medical Device Regulations (MDR)

CE Mark Certification: For manufacturers selling in Europe, obtaining the CE mark is mandatory.

EU MDR (Medical Device Regulation): The EU MDR requires manufacturers to provide comprehensive documentation, including clinical evidence of the device’s safety and performance. It also emphasizes post-market surveillance and reporting of adverse events.

4. Good Manufacturing Practices (GMP)

Compliance with GMP Guidelines: Manufacturers must follow GMP practices, which ensure that laparoscopic instruments are consistently produced and controlled according to quality standards. This includes maintaining cleanroom environments, proper equipment maintenance, and employee training.

Traceability and Documentation: GMP also requires maintaining detailed records of production batches, testing, and quality checks to ensure traceability and accountability.

Rudra Surgical is known as Laparoscopic Simulator Virtual Endo Trainer Manufacturer in India. If you or anyone you might know is searching for a reliable manufacturer of laparoscopic instruments, then you can connect with Rudra Surgical.

About Rudra Surgical

Rudra Surgical is one of the leading names because it offers a wide range of medical equipment by designing it precisely. To know more details about various medical equipment, you can connect with them without any delay.

[sigmabiomedical]

The role of predicate bDevices in a 510(k) Submission

In the process of bringing a medical device to the U.S. market, understanding the 510(k) submission is critical. One of the most significant aspects of a successful 510(k) submission is identifying and using a predicate device. A predicate device is a legally marketed device that is substantially equivalent to the new device being submitted. In other words, your device must be proven as safe and effective as the predicate to gain FDA clearance.

What is a Predicate Device?

A predicate device acts as a benchmark for comparing your medical device during the 510(k) submission process. This comparison helps demonstrate that your device is just as safe and effective as an already-approved device. The predicate device must have been legally marketed and must have received FDA approval under the 510(k) process itself, allowing you to make an equivalency claim based on its features, intended use, and safety profile.

Why Predicate Devices are Crucial

The U.S. Food and Drug Administration (FDA) requires substantial evidence that the new medical device is similar to an existing product. By referencing a predicate device, manufacturers reduce the time and cost of bringing a product to market. The focus is on demonstrating equivalency, which bypasses the need for extensive clinical trials or additional safety testing that would be required for completely novel devices.

Selecting an Appropriate Predicate Device

Choosing the right predicate device is one of the most important parts of the 510(k) submission process. The predicate should have the same intended use, technological characteristics, or performance outcomes as your new device. However, it is not necessary for your device to be identical in design. The key is demonstrating that any differences do not raise new questions about safety and effectiveness.

Working with professionals who offer 510(k) submission consulting can help ensure you choose the most suitable predicate device for your product. They assist in assessing various devices, identifying relevant predicates, and comparing critical attributes. This greatly enhances your submission’s success.

Key Elements of the 510(k) Submission

In the 510(k) submission, manufacturers must provide:

A detailed description of the new device.

A comparison chart to illustrate similarities and differences between the new device and the predicate.

Supporting data that demonstrates the device's safety and efficacy in line with the predicate.

Often, consulting with experts in Medical device 510(k) consulting can streamline this process. They can help you prepare and organize the required documentation and assist in any needed regulatory strategy adjustments.

Avoiding Common Pitfalls in Predicate Selection

One common challenge in the 510(k) submission process is selecting an inappropriate predicate device. Some devices may seem equivalent at first glance but may differ in key areas such as material, performance characteristics, or intended patient populations. It’s essential to ensure that these differences do not introduce new safety concerns.

A 510(k) submission consulting firm can help you navigate these complexities by conducting a thorough comparison and assessing whether the FDA will likely accept the chosen predicate. This can save valuable time and prevent costly delays during the regulatory review process.

Benefits of Professional Consulting

Medical device manufacturers are increasingly turning to Medical device 510(k) consulting services to guide them through the FDA clearance process. These consultants are well-versed in current FDA guidelines and predicate device strategies, making them valuable partners in achieving regulatory approval. They assist in documentation preparation, compliance with regulations, and establishing effective communication with the FDA.

By working with professional consultants, you can mitigate risks and ensure that your submission complies with all FDA requirements, giving you a higher chance of success.

Conclusion

Predicate devices play a pivotal role in the 510(k) submission process. Selecting the correct predicate and demonstrating substantial equivalence are key to gaining FDA clearance for your medical device. Consulting with experts in 510(k) submission consulting and Medical device 510(k) consulting can help you navigate this complex process with confidence, ensuring timely and successful FDA approval for your product.

This careful approach not only accelerates market entry but also ensures compliance with regulatory standards, paving the way for your device’s success in the U.S. healthcare market.

[elexes]

13 Common Mistakes to Avoid in the 510(k) Submission

If you are looking to market your cutting-edge medical device, which is low to moderate risk, in the United States you need FDA Clearance. That’s where the 510(k) submission comes into play!

[biotech-news-feed]

The US Food and Drug Administration (FDA) has granted 510(k) clearance for Avicenna.AI’s CINA-CSpine tool. The post Avicenna.AI receives 510(k) clearance for CINA-CSpine tool appeared first on Medical Device Network. #BioTech #science

[industryforecastnews]

Drug Testing Market Size To Reach USD 8.45 Billion By 2030

Drug Testing Market Growth & Trends

The global drug testing market size is expected to reach USD 8.45 billion by 2030, expanding at a CAGR of 4.8% from 2024 to 2030, according to a new report by Grand View Research, Inc.. The introduction of innovative tests, stringent regulation mandating drug testing, and growing substance abuse & addiction are some of the factors anticipated to foster market growth during the forecast period. 

Drug abuse and addiction is a global problem, affecting millions of people. As per the World Drug Report published by UNODC, in 2019, around 35.0 million people were suffering from drug use disorders globally. Such a high rate of drug abuse and substance use disorders has created a major demand for innovative tests to prevent, treat, and manage such cases. Several key players operating in this space are introducing innovative and efficient products to meet this growing demand.

For instance, in June 2019, Quidel Corporation received the U.S. FDA’s 510(k) clearance to market its fluorescence immunoassay—Quidel Triage TOX Drug Screen, 94600. This is intended for detecting the presence of metabolites or drugs in urine. Moreover, in June 2020, Cordant Health Solutions offered video-observed oral fluid drug testing to help courts & government agencies to monitor participants during the COVID-19 pandemic. This aided in combating several challenges faced by people with substance abuse disorders during the pandemic.

Continuous government initiatives and implementation of strict substance abuse testing regulations to ensure safety have derived the demand for its testing products. In July 2020, the New Zealand government introduced a new bill that provides police the power to conduct random roadside drug testing of drivers to reduce impaired driving in the country. The new bill allows usage of oral fluid tests to check drivers for substances such as cocaine, ecstasy, cannabis, opiates, methamphetamine, and benzodiazepines. Also, in February 2020, the Directorate General of Civil Aviation in India introduced extensive tests for pilots and flight crew members for psychoactive substances such as opioids & cannabis to ensure safe air travel.

Request a free sample copy or view report summary: https://www.grandviewresearch.com/industry-analysis/drug-testing-market

Drug Testing Market Report Highlights

By product type, the consumables segment dominated the market in 2023, owing to its repetitive use to conduct substance abuse screening

Based on sample type, the urine samples segment accounted for the largest revenue share in 2023, as it is the most common method of sample collection

Increased unemployment and economic crisis due to the Covid-19 pandemic has made people more susceptible to substance abuse, thus created lucrative opportunities in the market

The legalization of marijuana for medicinal as well as recreational use in several countries is anticipated to change the current scenario and may create demand for innovative testing solutions

Stringent privacy rights in some countries are likely to limit substance abuse testing at workplaces, impeding market growth

In Asia Pacific, the market is expected to witness lucrative growth over the forecast period as a result of the growing demand for substance abuse testing from emerging economies, such as China and India

Drug Testing Market Segmentation

Grand View Research has segmented the global drug testing market based on product, sample, drug, end-use, and region:

Drug Testing Product Outlook (Revenue, USD Million, 2018 - 2030)

Consumables

Instruments

Rapid Testing Devices

Services

Drug Testing Sample Outlook (Revenue, USD Million, 2018 - 2030)

Urine Samples

Oral Fluid Samples

Hair Samples

Other Samples

Drug Testing Drug Outlook (Revenue, USD Million, 2018 - 2030)

Alcohol

Cannabis/Marijuana

Cocaine

Opioids

Amphetamine & Methamphetamine

LSD

Others

Drug Testing End-use Outlook (Revenue, USD Million, 2018 - 2030)

Drug Testing Laboratories

Workplaces

Hospitals

Others

Drug Testing Regional Outlook (Revenue in USD Million, 2018 - 2030)

North America

Europe

Asia Pacific

Latin America

Middle East and Africa

Regional Insights

North America drug testing market dominated and accounted for a 39.5% share in 2023. This high share is attributable to the local presence of key global market players, such as Bio-Rad Laboratories, Laboratory Corporation of America Holdings, Thermo Fisher Scientific, F. Hoffmann-La Roche Ltd. and others. Moreover, the growth of the drug testing market in North America can majorly be attributed to the increasing incidence of abuse, stringent government regulations, and active screening programs. The governments are actively engaged in controlling the consumption of hazardous drugs to minimize the cost burden associated with it. In addition, the authorities are focusing on formulating new policies. For instance, in September 2023, San Francisco Human Services Agency (SFHSA) announced a new initiative that would need people suffering from substance use disorder who wish to gain access to county funds to enroll in treatment and services.

List of Key Players in Drug Testing Market

Quest Diagnostics Incorporated

Abbott

F. Hoffmann-La Roche Ltd.

Quidel Corporation

Thermo Fisher Scientific, Inc.

Siemens Healthcare GmbH

Bio-Rad Laboratories, Inc.

Agilent Technologies, Inc.

Laboratory Corporation of America Holdings

Clinical Reference Laboratory, Inc.

Cordant Health Solutions

Browse Full Report: https://www.grandviewresearch.com/industry-analysis/drug-testing-market  

[markjasonstubblefield]

Understanding the Role of Sales Representatives in the Medical Device Industry with Industry Leaders including Mark Jason Stubblefield

Mark Jason Stubblefield

Understanding the Role of Sales Representatives in the Medical Device Industry with Industry Leaders including Mark Jason Stubblefield

The medical device industry in the United States is a dynamic and highly regulated sector that plays a crucial role in healthcare delivery. At the forefront of connecting innovative medical technologies with healthcare providers are sales representatives. These professionals serve as vital links between manufacturers and hospitals, clinics, and other healthcare facilities. Understanding their pivotal role and the strategies involved in selling medical devices in the USA is essential for navigating this complex field effectively.

Importance of Sales Representatives in the Medical Device Sector

Sales representatives in the medical device industry are instrumental in introducing new technologies and equipment to healthcare professionals. They provide in-depth product knowledge, demonstrations, and training, helping healthcare providers understand the benefits and applications of various devices. By establishing relationships built on trust and expertise, sales professionals like Mark Jason Stubblefield facilitate informed decision-making among healthcare providers, ensuring that the most suitable medical devices are selected to meet patient needs.

Moreover, sales representatives act as consultants, offering insights into industry trends, regulatory requirements, and competitive landscapes. Their role extends beyond sales pitches to encompass ongoing support and education, fostering long-term partnerships with healthcare facilities. This proactive approach not only enhances customer satisfaction but also contributes to the advancement of healthcare through the adoption of cutting-edge technologies.

Regulatory Landscape and Compliance Requirements

Selling medical devices in the USA entails navigating stringent regulatory frameworks set forth by the Food and Drug Administration (FDA). Sales representatives must possess a thorough understanding of FDA regulations governing device classification, premarket approval (PMA), 510(k) clearance, and Quality System Regulation (QSR). Compliance with these standards is non-negotiable and requires meticulous attention to detail throughout the sales process.

Sales representatives collaborate closely with regulatory affairs teams within their organizations to ensure that all marketing materials and product claims align with FDA guidelines. They also provide healthcare providers with transparent information regarding the regulatory status and safety profile of the devices they promote. By maintaining adherence to regulatory requirements, leaders such as Mark Jason Stubblefield uphold the integrity of the medical device industry and promote patient safety.

Targeting and Engaging Healthcare Providers

Effective sales strategies in the medical device industry hinge on identifying and engaging with key stakeholders within healthcare facilities. Sales representatives conduct thorough market research to pinpoint target audiences, including physicians, surgeons, hospital administrators, and purchasing managers. They tailor their approaches to resonate with the specific needs and challenges faced by each healthcare provider, emphasizing how their devices can enhance patient outcomes and operational efficiencies.

Building relationships through personalized interactions is paramount. Sales representatives schedule meetings, demonstrations, and educational sessions to showcase the capabilities of their devices in real-world scenarios. They leverage data-driven insights and clinical evidence to substantiate the benefits of their products, fostering confidence and buy-in among healthcare professionals. By addressing concerns and highlighting value propositions, industry leaders including Mark Jason Stubblefield facilitate informed purchasing decisions that align with the strategic goals of healthcare facilities.

Demonstrating Product Value and Clinical Efficacy

Central to the sales process is demonstrating the value and clinical efficacy of medical devices. Sales representatives leverage clinical data, case studies, and peer-reviewed publications to substantiate the performance and benefits of their products. They collaborate closely with healthcare providers to conduct trials and evaluations, gathering feedback and real-world outcomes that validate the device's effectiveness in improving patient care.

In addition to clinical evidence, sales representatives emphasize the economic benefits of their devices. They conduct cost-benefit analyses and ROI assessments to illustrate potential savings in terms of procedural efficiency, patient recovery times, and overall healthcare expenditures. By presenting a comprehensive picture of both clinical and economic advantages, sales professionals like Mark Jason Stubblefield empower healthcare providers to make informed decisions that optimize patient care delivery while maximizing operational efficiencies.

Overcoming Challenges in the Sales Process

Selling medical devices in the USA presents unique challenges, including navigating complex procurement processes and addressing budgetary constraints within healthcare organizations. Sales representatives must navigate hierarchical decision-making structures and align their proposals with the strategic priorities of healthcare facilities. They anticipate objections and proactively address concerns regarding product performance, safety, and return on investment.

Moreover, maintaining competitive edge amidst a crowded marketplace requires continuous adaptation and innovation. Sales representatives stay abreast of industry trends, competitor activities, and technological advancements to differentiate their offerings effectively. By positioning their devices as solutions that meet evolving healthcare needs and regulatory standards, sales representatives enhance their value proposition and foster enduring partnerships with healthcare providers.

Building Long-Term Relationships and Support

Successful sales in the medical device industry are not solely transactional but relational. Sales representatives prioritize building long-term relationships with healthcare providers based on trust, integrity, and ongoing support. They offer comprehensive training programs, technical support, and post-sales service to ensure seamless integration and optimal use of their devices within clinical settings.

Furthermore, sales representatives serve as advocates for customer feedback and product improvement. They relay insights gathered from healthcare providers to manufacturers, facilitating continuous innovation and enhancement of medical devices. By demonstrating commitment to customer success and satisfaction, leaders such as Mark Jason Stubblefield reinforce their role as trusted partners in advancing healthcare delivery.

Sales representatives play a pivotal role in the medical device industry by bridging the gap between manufacturers and healthcare providers in the USA. Their expertise in product knowledge, regulatory compliance, and strategic engagement is instrumental in driving adoption and utilization of innovative medical technologies. By understanding the complexities of the sales process and emphasizing value-based relationships, sales representatives contribute to the advancement of healthcare through the delivery of high-quality, patient-centered care.