Author: FDAcop

Siemens Healthineers has recently received premarket approval from the FDA for the 3D imaging component of its newly redesigned mammography system, the Mammomat B.brilliant. This marks the company’s first major overhaul of its mammography platform in more than a decade. The approval highlights a significant advancement in the use of 3D imaging technology to enhance […]

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Philips recently initiated a recall for several models of its Trilogy ventilators due to a range of issues that potentially endanger patients by not providing sufficient ventilation or oxygen. The affected models include the Trilogy Evo, Trilogy EV300, Trilogy Evo O2, and Trilogy Evo Universal. This recall, affecting approximately 90,000 units globally—with about 67,000 located […]

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Eli Lilly has introduced a promising obesity treatment drug targeting two metabolic pathways, shedding significant weight and showing potential for substantial revenue generation. This innovative approach has spurred other pharmaceutical companies to enhance and replicate Lilly’s strategy. Among these companies, Kailera Therapeutics emerges as a significant player, entering the scene with robust funding support of […]

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GE Healthcare has achieved a significant milestone by securing approval from the Food and Drug Administration (FDA) for Flyrcado (flurpiridaz F 18), a new imaging agent designed for positron emission tomography (PET) scans, which are utilized in the detection of coronary artery disease. This cutting-edge agent boasts a notably longer half-life compared to existing tracers […]

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The Food and Drug Administration (FDA) has yet to issue new guidelines aimed at correcting racial disparities in the accuracy of pulse oximeters, despite initial announcements that new rules would be released by September 30. This delay follows revelations nearly four years ago that these devices, which measure blood oxygen levels, frequently fail to detect […]

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Establishment Labs has recently received premarket approval from the Food and Drug Administration (FDA) for its Motiva breast implants. This notable event marks the first new breast implant approved in the U.S. since 2013, introducing a significant shift in a market landscape previously altered by safety concerns, notably leading to the withdrawal of Allergan’s Biocell […]

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The innovative drug Dupixent, developed by Sanofi and Regeneron Pharmaceuticals, has already made a significant impact in the treatment of various skin and lung disorders. Recently, it has received FDA approval for a new indication—chronic obstructive pulmonary disease (COPD), a lung condition generally associated with smoking but also found in non-smokers. This approval marks a […]

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When Tesla launched its electric cars in 2012, it quickly established hundreds of charging stations nationwide, expanding to thousands globally and selling nearly 5 million vehicles since. Contrastingly, Electronic Health Records (EHRs), introduced in 1962, took over six decades to show significant benefits due to slow adoption in healthcare systems. This difference in deployment of […]

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An interdisciplinary team of Chinese researchers has made significant advancements in the field of continuous glucose monitoring (CGM) systems by developing a miniaturized device that potentially matches the performance of leading market alternatives. This new CGM sensor, designed utilizing an organic electrochemical transistor (OECT), offers improved amplification of the signal-to-noise ratio compared to traditional sensors, […]

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Mendaera, a Silicon Valley-based firm, recently raised $73 million to further develop a handheld robotics platform designed for a range of medical procedures including biopsies, organ and vascular access, and pain management. This funding initiative marks a substantial push towards revolutionizing commonly practiced medical procedures through advanced robotics. The company was co-founded by Josh DeFonzo […]

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