What You Should Know:
– Scopio Labs, a leader in digital cell morphology, has achieved a major breakthrough with FDA De Novo clearance for its Full-Field Bone Marrow Aspirate (FF-BMA) Application.
– The FDA clearance marks…
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Current solutions for remote health monitoring can be seen as invasive by patients and mostly do single variant intermittent tracking. FDA clearance brings one of Europe’s most advanced real-time continuous remote monitoring systems to…
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This week, Prenosis gained FDA clearance for its sepsis detection technology — marking the first time the agency has cleared an AI diagnostic tool for sepsis.
Chicago-based Prenosis was founded in 2014 with “a mission…
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Eko Health received FDA clearance this week for a new AI-powered tool that aids in the early detection of low ejection fraction, a key indicator of heart failure.
About 6.2 million Americans battle heart failure,…
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Eko Health celebrates a significant milestone with FDA 510(k) clearance for its AI-enabled cardiac tool, the Eko Low Ejection Fraction Tool (ELEFT). This groundbreaking innovation streamlines cardiac care by swiftly identifying low ejection fraction,…
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Digital cardiac and lung disease health startup Eko Health announced it received FDA 510(k) clearance for its AI-enabled cardiac tool that helps with the early detection of low ejection fraction, a key indicator of…
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What You Should Know:
– Eko Health, a provider of AI-powered heart and lung disease detection today announced FDA clearance for its Low EF detection AI.
– Built in collaboration with Mayo Clinic, the AI allows…
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Otsuka Pharmaceuticals and Click Therapeutics announced that Rejoyn, a smartphone-based prescription digital therapeutic for major depressive disorder (MDD), scored FDA clearance to be used as an adjunct to clinician-managed care. Rejoyn is a six-week remote…
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Siemens Healthineers’ unveiling of the MAGNETOM Terra.X MRI marks a significant milestone in healthcare innovation. With its FDA clearance, this state-of-the-art MRI scanner sets a new standard in imaging excellence, boasting advanced features like…
Digital ultrasound company Butterfly Network has achieved EU MDR certification for the Butterfly IQ+ ultrasound system, allowing the company to release its offerings into the European market, including its AI-enabled software Auto B-Line Counter…
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