Author: FDAcop

Signia, a prominent hearing aid manufacturer, has recently unveiled its latest advancement in hearing technology: the Signia Active Pro Integrated Xperience (IX) earbuds. These devices not only serve as state-of-the-art earbuds but also fulfill the criteria for prescription-grade hearing aids, blending aesthetic appeal with high-tech functionality. The core innovation in these new earbuds is the […]

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In 2023, a new analysis by ECRI and the Institute for Safe Medication Practices revealed that roughly one-third of adverse patient safety events reported by healthcare providers involved diagnostic testing errors. The analysis determined that the majority of these mistakes, nearly 70%, occurred during routine processes, such as ordering tests, collecting samples, or reporting results. […]

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Abbott, a prominent global healthcare company, has launched its innovative continuous glucose monitoring system called Lingo, which is now available for purchase in the U.S. without a prescription. This system is designed for individuals over 18 years old who are not using insulin. It incorporates technology based on Abbott’s FreeStyle Libre system, which has already […]

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In a significant legal ruling, Johnson & Johnson (J&J) has been ordered by a Delaware judge to pay over $1 billion to the former investors of Auris Health, a surgical robotics firm acquired by J&J in 2019. This verdict is the result of J&J’s failure to adhere to the terms of the merger agreement which […]

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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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