Author: FDAcop

Royal Philips, a well-known health technology company, recently unveiled an innovative product to enhance parental care and monitoring: the Philips Avent Premium Connected Baby Monitor. This state-of-the-art device integrates the company’s proprietary technologies including SenseIQ, which covers sleep and breathing patterns, along with cry-detection and translation capabilities, to afford parents a comprehensive monitoring tool for […]

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Pi-Cardia, a company specializing in medical devices, has recently received approval from the U.S. Food and Drug Administration (FDA) for a new device aimed at reducing the risk of coronary obstructions during valve-in-valve transcatheter aortic valve replacement (TAVR) procedures. Named the Shortcut, this device is designed to address complications associated with valve replacements in TAVR […]

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BD, a prominent medical device manufacturer, has entered into a settlement agreement to resolve the majority of its hernia mesh litigation, as announced by the company on Wednesday. While the specific terms of the agreement remain confidential, BD has clarified that it does not admit to any wrongdoing or liability. The company remains confident in […]

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The Safer Technologies Program (STeP) for Medical Devices is a novel, voluntary program established by the FDA to expedite the entry of medical devices into the US market by emphasizing improvements in safety over efficacy. The Global Medical Device Podcast, hosted by Jon Speer and featuring Mike Drues from Vascular Sciences, offers comprehensive insights into […]

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Sanofi’s Enjaymo, the singular approved therapeutic for a rare and challenging blood disorder known as cold agglutinin disease, is being acquired by the Italian pharmaceutical company Recordati in a strategic move to enhance its rare disease product line and broaden its market reach. The deal involves a base payment of $825 million for global rights […]

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Medtronic, a developer, manufacturer, and seller of medical therapy devices, has initiated a voluntary recall of its MiniMed insulin pumps, specifically the 600 and 700 series. The recall was prompted by concerns over a potentially shortened battery life, which could affect the device’s function and the user’s health. The action was publicly announced on July […]

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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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