FDA Clearance

FDA Clears First-in-World Hematology App, Unlocking Potential of Diagnosis

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What You Should Know: – Scopio Labs announced FDA clearance of its AI-powered X100 microscope and decision support system with Full Field Peripheral Blood Smear (Full Field PBS) application.  – Using advanced computational photography imaging and tailored AI tools, Full Field PBS gives clinical laboratories an… Read More »FDA Clears First-in-World Hematology App, Unlocking Potential of Diagnosis

Caption Health AI Awarded FDA Clearance for Point-of-Care Ejection Fraction Evaluation

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What You Should Know: – Caption Health AI is awarded FDA 510(k) clearance for its innovative point-of-care ejection fraction evaluation. – Latest AI ultrasound tool makes it even easier to automatically assess ejection fraction, a key indicator of cardiac function, at the bedside–including on the… Read More »Caption Health AI Awarded FDA Clearance for Point-of-Care Ejection Fraction Evaluation

Eko Awarded $2.7M NIH Grant for Heart Murmur & Valvular Heart Disease Detection Algorithms

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What You Should Know: – The National Institutes of Health (NIH) has granted next-generation cardiac AI company Eko an award totaling $2.7 million to support continued collaborative work with Northwestern Medicine Bluhm Cardiovascular Institute – The grant will focus on validating algorithms and help more… Read More »Eko Awarded $2.7M NIH Grant for Heart Murmur & Valvular Heart Disease Detection Algorithms