Sibel Health, a spin-out of Northwestern University, announced it received a new FDA 510(k) clearance for its ANNE One platform, to include continuous neonate and infant vital sign monitoring of babies at any gestational…
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Tech giant Samsung Electronics announced it received FDA clearance for its Health Monitor app’s Irregular Heart Rhythm Notification (IHRN) feature. IHRN works with the app’s electrocardiogram function to monitor heart rhythms suggestive of atrial fibrillation,…
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British company Ultromics has been granted FDA Breakthrough Device Status for its artificial intelligence (AI)-enhanced platform for detecting cardiac amyloidosis.EchoGo Amyloidosis uses AI technology to analyse echocardiograms to detect the presence of cardiac amyloidosis….
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What You Should Know:Today, Samsung announced today its Irregular Heart Rhythm Notification feature of the Samsung Health Monitor App has been cleared by the FDA. With this new feature, Galaxy Watch users can be alerted when…
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In order to carry out a seamless joint replacement, surgeons must create a customized preoperative plan for each patient. However, surgeons having to perform multiple operations per day are often too busy to dedicate…
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What You Should Know:Healthy.io, the global leader in transforming the smartphone camera into a clinical-grade device, raises $50M in a Series D funding round led by Schusterman Family Investments and is joined by Aleph…
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By Jill McKeon
May 03, 2023 – The US Food and Drug Administration (FDA) alerted healthcare providers and laboratory personnel of a cybersecurity vulnerability that impacts the Universal Copy Service (UCS) software in select Illumina medical…
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Casana, maker of a health monitoring smart toilet seat, announced this week it had received its first FDA 510(k) clearance.The startup’s Heart Seat received the agency green light for monitoring heart rate and oxygen…
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What You Should Know:Furthering Magenta’s Clinical Programs in Support of FDA Approval For World’s Smallest Heart PumpTemporary mechanical circulatory support (MCS) is one of the fastest growing markets in interventional cardiology, encompassing devices that…
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What You Should Know:Flatiron Health announced a new partnership today with Sanofi in their pursuit to redesign the clinical trial experience for sponsors, sites, and patients in the therapeutic area of oncology. The multi-study partnership between Sanofi and…
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