Tag Archives: FDAcopilot

Throughout 2023, the medical technology industry has experienced significant job losses, with more than 14,000 layoffs announced by medical device companies in the first half of the year alone. The diagnostic sector has been particularly impacted, facing over 5,000 job cuts during this period, representing the highest number of layoffs within the industry. Cepheid, a […]

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In an informative episode of the Global Medical Device Podcast, host Etienne Nichols welcomed Laura Maher to delve into the pivotal role of design assurance in the realm of medical device development. Etienne and Laura explored various facets of this critical area, emphasizing how crucial proper documentation and adherence to design controls are in achieving […]

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The Centers for Medicare and Medicaid Services has finalized a rule that simplifies the reimbursement process for medical device makers, particularly those with products designated as “breakthrough” technologies by the Food and Drug Administration (FDA). This move is aimed at accelerating the Medicare coverage availability for innovative medical devices immediately after they receive FDA approval. […]

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G1 Therapeutics, a biotech firm based in Research Triangle Park, North Carolina, has successfully guided its innovative lung cancer drug, Cosela, to FDA approval. Cosela is uniquely designed not to treat cancer directly but to protect bone marrow by blocking CDK4/6 proteins during chemotherapy for patients with extensive-stage small cell lung cancer. This marks the […]

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Unfortunately, the provided content is too brief and primarily descriptive of what the article aims to cover, rather than presenting substantive information from the article itself. As the text outlines, AgencyIQ analyzes public data to forecast likely actions by the FDA in the near future, which aids regulatory professionals in planning for key FDA-related deadlines, […]

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The Food and Drug Administration (FDA) is seeking public feedback on improving health equity through the regulation of medical devices, as outlined in a new discussion paper. Comments on the paper are open until October 4. This initiative is part of the Center for Devices and Radiological Health’s (CDRH) wider strategy that prioritizes health equity […]

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Jeff Shuren, the longstanding director of the medical device sector at the Food and Drug Administration (FDA), announced his departure in July, leaving many industry leaders, patient advocates, and FDA colleagues taken aback by his unexpected exit. His resignation came as a surprise particularly because Shuren had become a prominent figure within the FDA, admired […]

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Inspire Medical Systems recently received approval from the Food and Drug Administration (FDA) for its new obstructive sleep apnea (OSA) neurostimulator therapy, named Inspire V. The company announced plans to begin a soft launch of the device by the end of 2024 with a full launch projected for 2025. This news came shortly after Inspire […]

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Daniel Wilson has been named the new CFO of iRhythm Technologies, taking over from Brice Bobzien, who will step down due to personal reasons on August 31, as announced by the company. Bobzien, who joined iRhythm in August 2022 from Dexcom, expressed his decision on an earnings call, with CEO Quentin Blackford showing support and […]

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The development of drugs for autoimmune diseases is challenged by immune responses against biologic therapies. Emerging companies employ innovative techniques, including artificial intelligence and novel biologic drug platforms, to mitigate these risks and develop new treatments. Key advancements and investments in the field of Immunology and Inflammation show the dynamic landscape of biotech: Abiologics launched […]

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