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FDA Clearance

Scopio Labs Awarded FDA Clearance for High Throughput Hematology Digital Cell Morphology Platform, Replacing Microscopes with Digitization

Scopio Labs, a medtech company that develops AI-powered diagnostic platforms for earlier and more accurate detection of cancers, infections, and other diseases, announced that...

CoNextions TR Tendon Repair System Receives FDA Clearance

CoNextions Inc. , an innovator in tendon repair, is pleased to announce that CoNextions TR Tendon Repair System has received FDA 510(k) Clearance. Expected...

Israeli Startup Sanolla Receives FDA Clearance for the World’s First AI-Ready Infrasound Stethoscope

Israeli startup Sanolla, which provides AI-powered primary care diagnostic solutions, announced that the FDA has granted 510(k) clearance for the clinical use of the...

Envista Obtains FDA Clearance for Assisted Intelligence Mandibular Nerve Tracing

Envista Holdings Corporation -- Envista announced the 510(k) Food and Drug Administration (FDA) clearance of its Assisted Intelligence (AI) mandibular nerve tracing feature in...

Sky Medical Technology Wins Further FDA Clearance to Market the New Geko Device Variant for Venous Insufficiency and Ischemia

Sky Medical Technology Ltd (Sky) has announced it has achieved further U.S. Food and Drug Administration (FDA) 510(k) clearance to market the new (W3)...
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