#US FDA’s 510(k)

[elexes]

US FDA’s 510(k) Submission & Review Process

510(k) submission is one of the essential steps of getting medical devices approved in the United States. A 510(k) is an FDA regulatory pathway for medical device clearance.

It's crucial as it allows manufacturers to demonstrate that their new device is substantially equivalent to an existing one already on the market, expediting approval. 

This process promotes innovation, reduces development costs, and ensures patient safety by evaluating similarities and differences between devices.

Before you start your 510(k) filing, you must consider the below-mentioned factors. In case you wish to get support for 510(k) submission, you must check out our 510(k) submission consulting services.

[covid-safer-hotties]

Also preserved on our archive

By Mary Van Beusekom, MS

As the country heads into the respiratory illness season, the US Food and Drug Administration (FDA) announced yesterday its marketing authorization of the first over-the-counter (OTC) rapid-antigen COVID-19/flu combination test outside of emergency use authorization.

The Healgen Rapid Check COVID-19/Flu A&B Antigen Test takes 15 minutes to detect proteins from both COVID-19 and influenza A and B in nasal swabs. It joins other OTC COVID-19/flu tests already available under emergency use authorization. The test is designed for use by people aged 14 years or older collecting and testing their own sample or those 2 and older with adult assistance.

Risk of false-negative results FDA review of data from people with signs and symptoms of COVID-19 and flu showed that the test correctly identified 99% of negative and 92% of positive SARS-CoV-2 samples, 99.9% of negative flu A and B samples, and 92.5% and 90.5% of positive influenza A and B samples, respectively. The FDA and the National Institutes of Health's Independent Test Assessment Program collected the validation data.

The FDA reminded users of the risk of false-negative test results with rapid-antigen tests. People who test negative and continue to have fever, cough, and/or shortness of breath may indeed have COVID-19, flu, or another respiratory disease and should visit their healthcare provider. Those who test positive for COVID-19 or flu should take appropriate precautions to avoid spreading the virus and seek follow-up care.

The agency is also establishing criteria called special controls that define the labeling and performance-testing for these tests, the statement said.

"When met, the special controls, in combination with general controls, provide a reasonable assurance of safety and effectiveness for tests of this type," it said. "This action also creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through the FDA’s less burdensome 510(k) pathway."

[haccpcertificationinseychelles]

FDA Certification : A Comprehensive Guide

In today’s competitive global market, compliance with regulatory standards is essential for businesses operating in industries such as pharmaceuticals, medical devices, food manufacturing, and cosmetics. The U.S. Food and Drug Administration (FDA) sets stringent guidelines to ensure the safety, quality, and efficacy of products entering the U.S. market. For South African companies aiming to export to the U.S., obtaining FDA certification is a critical step. This article delves into FDA Certification in South Africa, the services available to facilitate certification, and the role of FDA consultants in ensuring compliance.

FDA Implementation in South Africa

FDA certification involves adherence to specific regulations governing product safety, labeling, manufacturing processes, and quality control. In South Africa, businesses seeking FDA approval must align their operations with these requirements to gain access to the lucrative U.S. market.

The implementation process typically begins with understanding the applicable FDA regulations. These vary depending on the product category:

Pharmaceuticals and Biologics: These products must comply with Good Manufacturing Practices (GMP) outlined in the Code of Federal Regulations (CFR). South African pharmaceutical companies often need to update their facilities, processes, and documentation to meet FDA standards.

Medical Devices: Manufacturers must determine the device’s classification and whether it requires premarket notification (510(k)) or premarket approval (PMA). Adherence to Quality System Regulations (QSR) is also mandatory.

Food Products: Compliance with the FDA’s Food Safety Modernization Act (FSMA) is crucial. This includes implementing hazard analysis and preventive controls to ensure food safety.

Cosmetics: These products must be safe for use and labeled accurately. While FDA approval isn’t mandatory for cosmetics, compliance with labeling and safety requirements is essential to avoid enforcement actions.

Businesses face unique challenges during implementation, such as navigating complex FDA Implementation in Bangalore requirements, bridging regulatory differences, and managing resource-intensive audits. However, with strategic planning and the right support, these challenges can be effectively addressed.

FDA Services in South Africa

South African companies can leverage a range of FDA-related services to streamline the certification process. These services are designed to help businesses navigate the complexities of FDA compliance and include:

FDA Registration and Listing: Companies must register their facilities and list their products with the FDA. This is a crucial first step for exporting goods to the U.S.

Regulatory Consulting: Experts provide guidance on FDA requirements specific to the product category, ensuring businesses understand their obligations.

Training and Workshops: Organizations offer training sessions on FDA regulations, such as GMP, FSMA compliance, and QSR requirements. These programs equip employees with the knowledge needed to maintain compliance.

Documentation Support: Preparing accurate and complete documentation is critical. FDA services include assistance with preparing regulatory submissions, such as Drug Master Files (DMFs), 510(k) applications, and food safety plans.

Audit Preparation and Mock Audits: Mock inspections help companies prepare for actual FDA audits, identifying areas of non-compliance and implementing corrective actions.

These services ensure that South African companies meet all FDA Services in Bahrain requirements, reducing the risk of non-compliance and facilitating smooth market entry.

FDA Consultants in South Africa

The expertise of FDA consultants is invaluable for South African businesses aiming for certification. These professionals possess in-depth knowledge of FDA regulations and offer tailored solutions to meet specific business needs. Here’s how they add value:

Gap Analysis: Consultants conduct a thorough review of existing processes, identifying gaps in compliance and recommending actionable improvements.

Custom Compliance Strategies: Based on the business’s goals and product category, consultants develop customized strategies to achieve FDA certification efficiently.

Regulatory Submission Assistance: Navigating FDA’s complex submission processes can be daunting. Consultants ensure that all submissions are accurate, complete, and compliant with regulatory standards.

Ongoing Support: Maintaining compliance is an ongoing process. FDA consultants provide continuous support to address regulatory updates, manage audits, and ensure adherence to best practices.

Choosing the right consultant is critical. South African businesses should look for professionals with proven experience, strong communication skills, and a track record of successful FDA certifications.

Conclusion

Achieving FDA Services in Uganda is a significant milestone for businesses seeking to expand into the U.S. market. By understanding the implementation process, utilizing specialized FDA services, and partnering with experienced consultants, companies can navigate the complexities of FDA compliance with confidence. With the right approach, South African businesses can unlock new opportunities and establish themselves as trusted exporters in the global marketplace.

[insightsresearch]

Printed & Flexible Sensors Market New Innovations Trends, Research, Global Share and Growth Factor

Analysis of Printed & Flexible Sensors Market Size by Research Nester Reveals the Market to Grow with a CAGR of 8.2% during 2025-2037 and Attain USD 29.5 billion by 2037

Research Nester assesses the growth and market size of the global printed & flexible market which is anticipated to be on account of the increasing demand for smartphones, laptops, and tablets.

Research Nester’s recent market research analysis on “Printed & Flexible Sensors Market: Global Demand Analysis & Opportunity Outlook 2037” delivers a detailed competitor’s analysis and a detailed overview of the global printed & flexible market in terms of market segmentation by printing technology, type, application, and by region.

Increased Integration in Biomedical Applications to Promote Global Market Share of Printed & Flexible Sensors

 The global printed & flexible sensors market is estimated to grow majorly due to the growing advancements and clinical approvals in biosensor technology. For instance, in May 2020, a global pioneer in health technology, Royal Philips, announced that the FDA approved its wearable biosensor, the Philips Biosensor BX100, under 510(k) to help monitor COVID-19 patients in hospitals, both proven and suspected. In the Philips patient deterioration detection system, the next-generation wireless wearable biosensor improves clinical monitoring to assist clinicians in identifying danger, allowing them to respond sooner and contributing to better patient care in lower acuity care areas. Because of their versatility and stretchability, flexible sensors have been utilized daily and have led to considerable breakthroughs, particularly in biomedical applications where they can adapt to complex geometries and be used on curved surfaces.

Medical biosensors are used in several instruments, including blood gas analyzers, pregnancy testing, blood glucose monitors, and cholesterol tastings. Proteins, nucleic acids, enzymes, and antibodies are some of the biological components that biosensors can detect and measure.

Some of the major growth factors and challenges that are associated with the growth of the global printed & flexible sensors market are:

Growth Drivers:

Growing technological advancements

Increased use in the production of sustainable energy

Challenges:

Conductive ink is cost-effective and easy to use compared to printed & flexible sensors. Also, the high costs of these sensors and inability to handle danger may impede the growth of printed & flexible sensors market.

Access our detailed report at: https://www.researchnester.com/reports/printed-and-flexible-sensors-market/6427

By printing technology, the global printed & flexible sensors market is segmented into flexographic, inkjet, and screen. The inkjet segment is expected to garner the highest revenue in 2037 at a significant CAGR over the forecast period. The expanding developments in inkjet printing technology and an increase in demand from various industries are responsible for the segment's expansion. For example, in July 2024, Ventec Giga Solutions, the value-added PCB equipment unit of Ventec, and Hi-Print worked together to launch the market's most cutting-edge inkjet printer for solder mask technology. With up to ten state-of-the-art printheads and the first-ever completely customizable three-color ink supply system, the Hi-Print SD11 Inkjet printer is a scalable, reconfigurable, modular, and adaptable system designed for PCB creation that will never go out of style. Furthermore, inkjet printing has several advantages when creating printed and flexible sensors, including the ability to create complex patterns, compatibility with a wide range of materials, and high resolution.

By region, the Europe printed & flexible sensors market is poised to generate the highest revenue by the end of 2037. The European automotive sector represents a significant market for printed and flexible sensors. These sensors offer functionalities such as touch-sensitive surfaces, driver assistance systems, and structural health monitoring, which are seamlessly integrated into the interiors of smart cars. The region's robust automotive manufacturing base, coupled with a strong emphasis on sustainability and connected vehicles, is driving the market demand for printed and flexible sensors.

Request Free Sample Copy of this Report @ https://www.researchnester.com/sample-request-6427

This report also provides the existing competitive scenario of some of the key players which includes the Canatu Oy, Interlink Electronics, Inc., Tekscan, Inc., Prophesee SA, Henkel AG & Co., KGaA, Peratech Holdco Limited, KWJ Engineering, T+Ink, Inc., Thin Film Electronics ASA, Renesas Electronics Corporation, and others.

Request for customization @ https://www.researchnester.com/customized-reports-6427

Research Nester is a leading service provider for strategic market research and consulting. We aim to provide unbiased, unparalleled market insights and industry analysis to help industries, conglomerates and executives to take wise decisions for their future marketing strategy, expansion and investment etc. We believe every business can expand to its new horizon, provided a right guidance at a right time is available through strategic minds. Our out of box thinking helps our clients to take wise decision in order to avoid future uncertainties.

Contact for more Info:

AJ Daniel

Email: info@researchnester.com

U.S. Phone: +1 646 586 9123

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[darkmaga-returns]

It has been over a decade since my late-wife, Dr. Amy Josephine Reed, was harmed and killed by a poorly regulated medical device, known as the Power Morcellator. The sheer force of Dr. Reed’s voice, as a Harvard Medical School faculty member and a physician-scientist — and the injustice it uncovered to countless other women like her — became a bellwether case that demonstrates an ongoing and severe safety failure operational in the medical device regulatory space at FDA.

Of course, this safety failure in the FDA’s medical device regulatory arm, the Center for Devices and Radiological Health (CDRH), is hardly unique to that center. Industry and conflicted academic “experts,” not patients, play an outsized role in governing and corrupting almost all of the FDA’s centers. But, certainly, the source of the safety failure at CDRH is crystallized in the dangerous regulatory regime that the agency center utilizes to clear the vast majority of medical devices for the US healthcare marketplace: The 510(k).

At a legislative level, CDRH’s 510(k) regulatory regime was not designed to ensure the safety or efficacy of the medical devices it regulates — a fact that is well known to most public health experts and FDA regulators themselves. CDRH’s 510(k) does not use anything even remotely resembling an “evidence-based” framework to provide clearance to thousands of new medical devices annually used in the care of patients across the US and abroad.

Even more problematic is that the medical device industry pays the FDA for the 510(k) clearances obtained. In other words, almost the entire 510(k) clearance apparatus at CDRH is literally funded by the medical device industry — the very industry that stands to gain the most from the 510(k) clearances it funds. This is a serious conflict of interest in the healthcare space, and should not pass ethical muster — even when the argument is that such payments from industry to government are saving taxpayer dollars. The moment the industry starts paying to keep the FDA’s centers’ lights on is when the industry, not the people, will have an outsized voice in governing the agency that is regulating it.

[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]

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.

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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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Navigating Medical Device Compliance: Expert Regulatory Consulting Services

In the highly regulated field of medical devices, ensuring compliance with industry standards and regulations is crucial for bringing products to market and maintaining their legality. Medical Device Regulatory Consulting Services are essential for companies looking to navigate complex regulatory landscapes and achieve successful product launches. Here’s how expert consulting services can help streamline the process and ensure your medical devices meet all necessary requirements.

Understanding Medical Device Regulations

1. Global Regulatory Landscape

Medical device regulations vary significantly across different regions, including the U.S., Europe, and other international markets. In the U.S., the FDA (Food and Drug Administration) sets rigorous standards for medical devices, while the European Union has its own set of regulations under the MDR (Medical Device Regulation) and IVDR (In Vitro Diagnostic Regulation). Understanding these regulations is essential for global market access.

2. Classification and Requirements

Medical devices are classified based on their risk levels, intended use, and technological characteristics. Each classification has specific regulatory requirements that must be met. Consulting services help determine the appropriate classification for your device and guide you through the corresponding regulatory pathways.

Key Benefits of Medical Device Regulatory Consulting Services

1. Expert Guidance on Compliance

Regulatory consultants provide expert advice on navigating the complex regulatory requirements for medical devices. They ensure that your device meets all necessary standards, including safety, effectiveness, and quality, helping you avoid costly delays and non-compliance issues.

2. Streamlined Submission Processes

Consultants assist in preparing and submitting regulatory documents, including 510(k) submissions, PMAs (Premarket Approvals), CE Mark applications, and other necessary paperwork. They help ensure that submissions are complete, accurate, and compliant with regulatory requirements, expediting the approval process.

3. Risk Management and Quality Assurance

Effective risk management and quality assurance are critical for medical device compliance. Consultants help implement robust risk management plans, conduct thorough documentation reviews, and establish quality management systems (QMS) that align with ISO 13485 standards, ensuring ongoing compliance throughout the product lifecycle.

4. Market Access and Strategy

Consultants provide strategic advice on market access, helping you understand and meet the specific requirements for different regions. They assist in developing regulatory strategies that align with your business goals and facilitate smoother entry into international markets.

5. Ongoing Support and Updates

Regulatory requirements are constantly evolving, and staying up-to-date is essential. Consulting services offer ongoing support and updates on regulatory changes, helping you adapt to new requirements and maintain compliance over time.

Choosing the Right Regulatory Consulting Partner

1. Experience and Expertise

Select a consulting firm with extensive experience and expertise in medical device regulations. Look for consultants who have a proven track record of successful submissions and regulatory approvals in your specific device category.

2. Understanding of Your Industry

Choose a consultant who understands your particular industry segment and the unique challenges associated with your device. Their industry knowledge will be invaluable in addressing specific regulatory concerns and ensuring compliance.

3. Personalized Service

Opt for a consulting firm that offers personalized service and is responsive to your needs. Effective communication and a tailored approach are crucial for addressing your specific regulatory challenges and achieving successful outcomes.

Conclusion

Medical device regulatory consulting services play a vital role in helping companies navigate the complex regulatory landscape and achieve compliance. By leveraging expert guidance, streamlined submission processes, and ongoing support, you can ensure that your medical devices meet all necessary requirements and successfully enter the market. Partnering with a reputable consulting firm will provide you with the expertise and resources needed to achieve regulatory success and maintain ongoing compliance.