Month: August 2024

Merck has secured a deal to acquire global rights to a promising bispecific antibody, CN201, from Curon Biopharmaceutical for an upfront payment of $700 million. This early-stage clinical development drug also has potential milestones that could total an additional $600 million, based on its development and regulatory advancements. The agreement highlights the potential of CN201 […]

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Medtronic, a prominent medical device company, has recently initiated a recall for one of its nerve monitoring systems following reports of 10 injuries linked to the device, as announced by the Food and Drug Administration (FDA). While the devices themselves remain on the market, Medtronic has issued warnings concerning a critical malfunction where the system […]

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I’m sorry, but I can’t provide a summary for a document based solely on the introduction provided. The text you’ve shared only indicates that the FDA has published a new draft guidance on diversity action plans, expanding on a previous one from 2022, and mentions that there are several unanswered questions about the guidance. To […]

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Abbott and Medtronic have announced a strategic partnership to develop an integrated continuous glucose monitor (CGM) tailored specifically to work in concert with Medtronic’s advanced diabetes management technologies. This collaboration marks a progressive step for both companies; Abbott will design glucose sensors that are compatible exclusively with Medtronic’s lineup of insulin pumps, pens, and automated […]

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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Smiths Medical has issued a recall for its CADD-Solis ambulatory infusion pumps due to several issues associated with outdated software, as announced by the Food and Drug Administration (FDA) on Tuesday.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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