Author: FDAcop

The Food and Drug Administration (FDA) has recently issued warning letters to four companies concerning their marketing of devices intended to clean continuous positive airway pressure (CPAP) machines. These devices, which claim to employ methods such as ozone gas or ultraviolet (UV) light, lack FDA clearance or approval. Specifically, the FDA has advised that it […]

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Subtle Medical, an AI-powered medical imaging company, has recently secured Phase II funding from an NIH small business innovation research (SBIR) grant to expand its innovative SubtleSYNTH technology into brain imaging applications. This advancement follows the company’s successful acquisition of FDA approval for its SubtleSYNTH technology in synthesizing STIR (short tau inversion recovery) images from […]

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Abbott is in the process of integrating its latest continuous glucose monitor (CGM), the Freestyle Libre 3 Plus, with Beta Bionics’ automated insulin delivery (AID) system known as the iLet Bionic Pancreas. This collaboration aims to enhance diabetes management by automating insulin delivery based on precise glucose readings from Abbott’s CGM. The expected launch of […]

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Owlet, a company specializing in technology for babies, has recently announced its expansion into several European countries, including Greece, Poland, the Czech Republic, Romania, Slovakia, Hungary, and Bulgaria. The expansion involves the Dream Sock baby monitor, a device that has gained significant attention due to its innovative technology. The Dream Sock, which received FDA clearance […]

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The Advanced Research Projects Agency for Health (ARPA-H), which operates under the U.S. Department of Health and Human Services, has recently initiated a program focused on enhancing the reliability and performance of medical devices that incorporate artificial intelligence (AI). This initiative arises from concerns that the effectiveness of AI-driven tools may deteriorate over time due […]

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New Jersey-based The Vitamin Shoppe is expanding its Whole Health Rx telehealth service by partnering with Marius Pharmaceuticals to offer men with low or inadequate testosterone levels access to Kyzatrex CII capsules. Whole Health Rx, launched recently, leverages the platform powered by WellSync to provide virtual care tailored to individual company needs, encompassing online medical […]

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Embecta, a notable company in the medical device sector, recently announced receiving 510(k) clearance from the Food and Drug Administration (FDA) for its first insulin patch pump. This device is specifically designed for individuals diagnosed with either Type 1 or Type 2 diabetes and is capable of being worn for up to three days per […]

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Premarket Approval (PMA) is the most demanding regulatory process in the United States for Class III medical devices, which are considered high-risk. These devices might be crucial for sustaining life, important for preventing significant health impairments, permanently implanted, or present a high degree of risk and potential for fatality. The FDA requires substantial clinical data […]

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As Labor Day approaches, marking the end of summer, many students are gearing up for the new school year, a period often fraught with concerns for children with food allergies. This year, however, brings a fresh development: the FDA’s recent approval of the first epinephrine nasal spray, neffy, by ARS Pharma. This alternative to the […]

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In a significant shift within the medtech sector, particularly in diabetes care, major players are forming alliances that were once considered unlikely, as fierce competitors turn into collaborative partners. Traditionally known for its proprietary nature, the medical device industry, especially in diabetes care technology, is now witnessing a major transformation towards openness and integration. The […]

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