Tag Archives: AI

Royal Philips Introduces New Smart Baby Monitor

Royal Philips Introduces New Smart Baby Monitor

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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FDA Approves Pi-Cardia’s Valve-in-Valve TAVR Device

FDA Approves Pi-Cardia’s Valve-in-Valve TAVR Device

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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Exploring the Safer Technologies Program (STeP): Is Your Device Eligible?

Exploring the Safer Technologies Program (STeP): Is Your Device Eligible?

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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Elucid Secures FDA 510(k) Approval for Cardiac Plaque Imaging Analysis Software

Elucid Secures FDA 510(k) Approval for Cardiac Plaque Imaging Analysis Software

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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Trends, Compliance, and Quality Systems in MedTech

Trends, Compliance, and Quality Systems in MedTech

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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Independent Laboratory Responds Following Philips’ Lawsuit Over Test Results

Independent Laboratory Responds Following Philips’ Lawsuit Over Test Results

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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Prioritize Safety: Back Legislation to Tackle the Crisis of Adverse Drug Events

Prioritize Safety: Back Legislation to Tackle the Crisis of Adverse Drug Events

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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