#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.

[industrynewsupdates]

Understanding the Key Drivers Behind Biopsy Devices Market Growth

The global biopsy devices market was valued at USD 2.25 billion in 2023 and is expected to grow at a CAGR of 7.2% from 2024 to 2030. This growth is primarily driven by several factors, including the rising prevalence of cancer worldwide. As cancer rates increase, the demand for early detection and diagnostic tools, including biopsy devices, is expected to rise significantly. Additionally, the growing emphasis on minimally invasive surgeries has spurred the adoption of biopsy procedures that involve less discomfort and quicker recovery times for patients, further driving market growth.

Another key factor contributing to the market's expansion is the presence of untapped opportunities in emerging economies, particularly in the Asia Pacific region. As these regions experience improvements in healthcare infrastructure and access to medical technologies, there is a growing demand for advanced diagnostic tools, including biopsy devices. This expansion into emerging markets presents significant growth potential for industry players.

In addition, government and healthcare bodies worldwide are taking proactive steps to reduce the high costs associated with cancer treatment. Many governments are prioritizing healthcare reforms that make cancer care more accessible and affordable, which in turn drives the need for efficient diagnostic tools like biopsy devices. Health organizations are also encouraging people to undergo regular diagnostic examinations through various awareness campaigns aimed at early cancer detection.

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

Regional Insights

The North America biopsy devices market dominated the global market in 2023, accounting for 43.1% of the total revenue share. This dominance can be attributed to the rising prevalence of cancer in the region, along with the continuous advancement of technologically sophisticated biopsy devices. For instance, in September 2023, the U.S. Food and Drug Administration (FDA) granted 510(k) clearance to Limaca Medical's Precision GI endoscopic ultrasound biopsy device. Such technological developments are expected to further boost market growth in North America, where the demand for accurate, minimally invasive diagnostic tools is continually increasing.

U.S. Biopsy Devices Market Trends

The U.S. biopsy devices market accounted for 34.6% of the global market share in 2023. According to the National Cancer Institute, approximately 2,001,140 new cases of cancer are expected to be diagnosed in the U.S. in 2024, driving the demand for biopsy devices. The rise in cancer prevalence, coupled with the U.S.'s strong healthcare infrastructure and a regulatory environment conducive to the development of advanced medical technologies, will likely fuel market growth. The presence of leading healthcare institutions, research facilities, and regulatory bodies such as the FDA further supports innovation and the availability of cutting-edge biopsy technologies in the country.

Europe Biopsy Devices Market Trends

In 2023, Europe emerged as a lucrative region for the biopsy device market. The growing number of cancer cases and the increasing need for advanced diagnostic and treatment technologies are key factors driving the demand for biopsy devices in this region. Cancer is the second leading cause of death in Europe, with over 3.7 million new diagnoses and 1.9 million deaths annually, according to the World Health Organization (WHO). This high cancer burden necessitates the development and adoption of advanced biopsy devices to enable early and accurate diagnosis.

UK

The UK biopsy devices market is expected to experience rapid growth in the coming years due to several factors, including the presence of major biopsy device manufacturers, rising public awareness regarding preventive healthcare, and national campaigns aimed at promoting early cancer detection. For example, the UK government runs campaigns like 'Be Clear on Cancer' (BCoC) and 'Help Us Help You' (HUHY), which encourage individuals to seek early diagnostic screening for various types of cancer. These initiatives are likely to drive increased adoption of biopsy devices in the region.

Asia Pacific Biopsy Devices Market Trends

The Asia Pacific biopsy devices market is anticipated to grow at the fastest CAGR over the forecast period. The growth is primarily attributed to the rising cancer incidence in the region, along with the growing demand for advanced diagnostic equipment to meet the increasing healthcare needs of the population. As economies like China and India continue to develop their healthcare infrastructure, there is a notable rise in demand for advanced diagnostic tools, including biopsy devices.

According to Global Cancer Statistics 2020, Asia accounted for half of all global cancer cases and 58.3% of cancer-related deaths, making the region a focal point for cancer treatment and diagnostic advancements. Governments in the region are launching initiatives such as awareness programs and screening campaigns to facilitate early cancer diagnosis and treatment, which are expected to drive further growth in the biopsy devices market.

India

In India, the biopsy device market is expected to grow significantly due to efforts from both public and private sectors to improve cancer diagnosis and treatment. The development of healthcare infrastructure is also a key driver. For instance, in July 2024, the MR Fusion Biopsy machine was installed at Sir H.N. Reliance Foundation Hospital in Maharashtra, India. This machine is the first of its kind in the state and is expected to enhance cancer care capabilities, contributing to the growth of the biopsy devices market in the country.

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

• The global neurology ultrasonic market size was valued at USD 430.1 million in 2023 and is projected to grow at a compound annual growth rate (CAGR) of 5.6% from 2024 to 2030. 

• The global collateral ligament stabilizer system market size was valued at USD 2.08 billion in 2023 and is projected to grow at a compound annual growth rate (CAGR) of 6.4% from 2024 to 2030.

Key Biopsy Devices Company Insights

The global biopsy devices market is characterized by the presence of several key players such as Cardinal Health Inc., Hologic, Inc., and Danaher Corporation, among others. These companies are actively involved in research and development (R&D) to create technologically advanced biopsy products that can improve the accuracy, efficiency, and comfort of biopsies, thereby maintaining a strong competitive position in the market.

For example, in August 2022, Devicor Medical Products, Inc. launched the Mammotome DualCore Dual Stage Core Biopsy System. This innovative system is designed to enhance biopsy accuracy and provide a better patient experience, which is expected to help the company expand its product portfolio and strengthen its market position.

• Cardinal Health Inc. is a global healthcare services and products company, primarily operating in the pharmaceutical and medical sectors. The company produces a range of minimally invasive biopsy devices, including fine needle core biopsy (FNCB) needles, bone marrow biopsy and aspiration needles, and Tissue Biopsy Kits.

• Hologic, Inc. is a global leader in the development and manufacture of medical imaging, diagnostic products, and surgical devices, including biopsy devices. The company has introduced advanced systems such as the Eviva Breast Biopsy system and the Brevera breast biopsy system to provide more accurate and efficient biopsy procedures, helping it maintain a competitive edge in the market.

Key Biopsy Devices Companies:

The following are the leading companies in the biopsy devices market. These companies collectively hold the largest market share and dictate industry trends.

• Cardinal Health Inc.

• Hologic, Inc.

• Danaher Corporation

• CONMED Corporation

• Cook Medical

• DTR Medical

• INRAD, Inc.

• Devicor Medical Products Inc.

• Gallini Srl

• TransMed7, LLC.

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

[drcare4u]

Acuitive Technologies Receives FDA 510(k) Clearance for CITREPORE™, A New Synthetic Bioactive Bone Void Filler for Orthopedic Procedures

ALLENDALE, N.J., Nov. 12, 2024 (GLOBE NEWSWIRE) — Acuitive Technologies, Inc. today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market CITREPORE, a unique synthetic bioactive bone void filler, using their patented CITREGEN® biomaterial technology. Following placement in a bony void, CITREPORE is resorbed predictably and replaced by the patient’s…

[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.

[researchreportinsight]

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.

[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.

[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!

[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

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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…

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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.

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