Scopio Labs gains De Novo clearance for AI bone marrow analysis software and more FDA clearances
Israel-based Scopio Labs announced the FDA granted De Novo clearance for its Full-Field Bone Marrow Aspirate (FF-BMA) software that provides ...
Tag: clearance
Eko Health’s AI-enabled cardiac tool receives FDA clearance
Digital cardiac and lung disease health startup Eko Health announced it received FDA 510(k) clearance for its AI-enabled cardiac tool ...
Otsuka, Click Therapeutics get FDA clearance for prescription digital therapeutic
Otsuka Pharmaceuticals and Click Therapeutics announced that Rejoyn, a smartphone-based prescription digital therapeutic for major depressive disorder (MDD), scored FDA ...
Dexcom over-the-counter Stelo Glucose Biosensor wins FDA clearance
An over-the-counter steady glucose monitoring (CGM) resolution developed by Dexcom known as Stelo has acquired clearance from the Meals and ...
