MobiHealth News April 25, 2024
Trevor Dermody

Epitel received 510(k) clearance for two remote monitoring offerings and Curio Digital Therapeutics received clearance for its postpartum prescription digital therapeutic.

Israel-based Scopio Labs announced the FDA granted De Novo clearance for its Full-Field Bone Marrow Aspirate (FF-BMA) software that provides AI-enabled decision support tools for bone marrow analysis.

The FF-BMA application allows for bone marrow aspirate analysis. It combines full-field imaging and an AI-powered decision support system that allows hematopathologists to analyze bone marrow smears remotely.

Scopio Labs produces machines that process blood and other cells in high detail. The company sells an application that is similar to the newly cleared application called Full-Field Peripheral Blood Smear (FF-PBS) that is based on peripheral blood smears.

“Scopio’s...

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Topics: AI (Artificial Intelligence), Digital Health, FDA, Govt Agencies, Technology
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