2023 was a banner year for MedTech, especially in terms of technological innovations. Incidentally, it also witnessed the largest ever number of FDA approvals on novel medical devices in a single year. This list…
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What You Should Know:
– GE HealthCare has received FDA 510(k) clearance for its innovative Portrait VSM vital signs monitor. This portable device promises to revolutionize patient care by offering clinicians a more efficient and…
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Baby tech company Owlet and telehealth staffing and services company Wheel announced they are partnering to allow Wheel’s clinicians to prescribe caregivers Owlet’s medical pulse oximetry wire-free sock for infants. Owlet’s BabySat, which received FDA…
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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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