Tag Archives: FDAcopilot

GE Healthcare recently announced that it has gained 510(k) clearance for a new diagnostic tool aimed at aiding in the assessment of Alzheimer’s disease. This tool incorporates a Centiloid scale into GE Healthcare’s Mim software, enhancing the ability of clinicians to quantify the density of amyloid plaque from PET scans in patients’ brains. Amyloid plaques, […]

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Some users of the Freestyle Libre 3 glucose sensor, a product by Abbott, are currently experiencing delays in getting their prescriptions filled. The delays are primarily due to a significantly high demand for the Libre 3 sensors, according to Abbott spokesperson Lindsy Delco. She explained that the company is actively enhancing production capacities to meet […]

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The Food and Drug Administration (FDA) has appointed Ross Segan, a former industry executive with a background at Olympus and also an Army veteran, as the head of the division responsible for ensuring the safety of medical devices. This decision comes as significant, considering Segan’s recent tenure as Chief Medical Officer at Olympus from 2020 […]

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Elon Musk’s Neuralink, a startup focused on developing brain-computer interfaces (BCIs), has recently been granted FDA Breakthrough Device Designation for its new product, Blindsight. Blindsight is an innovative implant designed to restore vision for individuals who are blind, targeting the visual cortex in the brain. The core function of Blindsight involves implanting a microelectrode array […]

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The MedCity News INVEST Digital Health Conference in Dallas brought together executives from the direct-to-consumer medical testing industry, who discussed the challenges and opportunities in this growing field. Robert Weigle, CEO of NOWDiagnostics, highlighted the difficulties in obtaining funding and FDA clearance. He emphasized the complexity and high costs associated with developing diagnostic tests, noting […]

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Clinical trials are seen as the benchmark for deriving clinical data demonstrating the safety and effectiveness of medical devices. However, they are not the sole method of accumulating clinical evidence. Real-World Data (RWD), which typically comes from routine healthcare or non-interventional studies such as registries, offers another viable evidence source. By collecting and analyzing RWD, […]

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STAT has launched an exclusive tracker for medical devices that have been granted breakthrough status by the Food and Drug Administration (FDA). This designation is crucial as it enables a faster route to the market for groundbreaking and potentially lifesaving medical innovations. The tracker reveals a variety of devices receiving this status, with a notable […]

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Zimmer Biomet, a prominent medical device manufacturer, is set to discontinue sales of its CPT Hip System by December due to increasing concerns over the risk of thigh bone fractures, as stated by the Food and Drug Administration (FDA). These concerns were heightened earlier this month when the U.K.’s Medicines and Healthcare products Regulatory Agency […]

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In an insightful episode of the Global Medical Device Podcast, host Etienne Nichols engages in conversation with Subhi Saadeh, renowned host of the Combinate Podcast and an expert on combination products. The discussion revolves around the multifaceted nature of combination products that blend drugs, devices, and biologics, shedding light on both regulatory hurdles and the […]

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Synchron, a developer of brain-computer interface (BCI) technology similar to that of Elon Musk’s Neuralink, has made significant progress in enabling people with severe paralysis to control smart home devices using their thoughts. This has been demonstrated by a patient with amyotrophic lateral sclerosis (ALS), who can now operate his smart home environment by interfacing […]

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