Month: October 2024

Elucid, a company specializing in medical imaging analysis software, has received FDA 510(k) clearance for its new software named PlaqueIQ. This innovative software is a tool intended to assist physicians in diagnosing cardiovascular disease by enhancing the analysis of coronary CT angiography images. PlaqueIQ achieves this through the creation of 3D models that both quantify […]

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In the Global Medical Device Podcast, host Etienne Nichols engages with Vincent Cafiso, a seasoned expert with 30 years of experience in life sciences and regulatory affairs, and the current Director of Quality and Regulatory Services at Creo Consulting. Previously an FDA investigator, Vincent offers invaluable insights into the complexities of FDA inspections, the establishment […]

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PSN Labs, a laboratory based in Erie, Pennsylvania, has countered allegations made by Philips in a legal filing, asserting that Philips misrepresented test results concerning the soundproofing foam in its sleep and respiratory devices. This dispute arises from Philips suing PSN Labs for purported errors in its analysis which Philips claims led them to mishandle […]

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Adverse drug events (ADEs) claim approximately 275,000 American lives annually, a staggering figure that equates to the daily loss equal to four full 737 plane crashes. This significant public health issue often goes unnoticed due to its dispersed occurrence across various settings including homes, clinics, and hospitals, and through outdated surveillance and reporting systems that […]

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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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