Tag Archives: Compliance

In the initial meeting of the FDA’s Genetic Metabolic Diseases Advisory Committee, discussions focused on a drug called arimoclomol, developed by Zevra, intended to treat the ultra-rare lysosomal storage disorder known as Niemann-Pick Type C. This session marked Zevra’s second attempt to gain approval for the drug after previous efforts had fallen short. The committee […]

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Dive Brief: Smiths Medical has issued a recall for its CADD-Solis ambulatory infusion pumps due to several issues associated with outdated software, as announced by the Food and Drug Administration (FDA) on Tuesday. The reported problems include the devices failing to emit necessary alarms, unresponsive stop and power keys, and the inadvertent exposure of passwords […]

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The Centers for Medicare and Medicaid Services (CMS) announced a new pathway, Transitional Coverage for Emerging Technologies (TCET), aimed at accelerating Medicare coverage for innovative medical devices. Traditionally, obtaining national Medicare and commercial insurance coverage for a device post-Food and Drug Administration (FDA) authorization can take up to five years. To address this lag, the […]

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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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