clearance

Bronny James receives medical clearance to play in NBA

FILE – Southern California’s Bronny James (6) drives up the court against Washington during the first half of an NCAA…

2 months ago

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…

2 months ago

Patient-friendly real-time remote monitoring system receives FDA clearance

Current solutions for remote health monitoring can be seen as invasive by patients and mostly do single variant intermittent tracking.…

3 months ago

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…

3 months ago

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…

3 months ago

Ionic Health gains FDA 510(k) clearance for nCommand Lite

GE HealthCare announced that its Brazil-based partner Ionic Health received FDA 510(k) clearance for its nCommand Lite, which provides diagnostic…

3 months ago

Dexcom over-the-counter Stelo Glucose Biosensor wins FDA clearance

An over-the-counter continuous glucose monitoring (CGM) solution developed by Dexcom called Stelo has received clearance from the Food and Drug…

4 months ago

GE HealthCare scores 510(k) clearance for maternal and fetal monitoring platform

GE HealthCare received FDA 510(k) clearance for its Novii+ maternal and fetal monitoring solution, which will become available to U.S.…

5 months ago

Zeta Surgical mixed reality navigation gets FDA special 510(k) clearance

Surgical robotics and mixed reality company Zeta Surgical announced it secured FDA special 510(k) clearance for advanced functionalities and expanded…

6 months ago

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