Tag Archives: FDAgpt

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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In an engaging episode of the Global Medical Device Podcast, host Etienne Nichols welcomed Dr. Asha Parekh, the CEO and co-founder of Frontline Medical Technologies. The discussion meticulously explored Dr. Parekh’s unconventional journey from a biomedical engineer to becoming an “accidental entrepreneur,” focusing on her critical role in developing innovative medical devices that significantly impact […]

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Senseonics, in partnership with Ascensia Diabetes Care, has received FDA clearance for an innovative medical device, the Eversense 365, an implantable glucose sensor designed for a wear time of one year. This clearance marks a significant advancement as it allows the sensor to be worn for double the duration of Senseonics’ previous model. The Eversense […]

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Implantable defibrillators are critical lifesaving devices used to correct abnormal heart rhythms by delivering a high-voltage shock, restoring the heart’s normal rhythm. However, defects in these devices can sometimes prevent them from functioning correctly, posing significant risks. In 2022, a significant event highlighted these risks when Medtronic issued a recall for over 85,000 defibrillator devices […]

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Connected health technology company Withings has achieved an exciting milestone by obtaining FDA 510(k) clearance for its innovative Sleep Rx Mat, a device specifically engineered to facilitate the home-based diagnosis of sleep apnea without direct contact with the body. The Sleep Rx Mat employs an advanced pneumatic sensor that meticulously tracks a wide range of […]

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