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FDA Clearance

NeoDynamics Received FDA Clearance For Pulse Biopsy System Neonavia

The MedTech company NeoDynamics has received approval for its innovative pulse biopsy system NeoNavia® from the US Food and Drug Administration, FDA. The US breast...

Medtronic Receives FDA Clearance for Next-Generation UNiD Spine Analyzer

Medtronic plc, a global leader in healthcare technology, today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its UNiD...

Zsquare receives FDA Clearance to Market for First High-Performance Single-Use ENT Endoscope

Zsquare, a leading developer of high-performance, single-use endoscopes, announces that it received Food and Drug Administration 510K clearance to market its first product, the...

Acepodia Announces FDA Clearance of IND Application for ACE1831, an Anti-CD20 Armed Allogeneic gamma delta T-cell Therapy

Acepodia, a clinical-stage biotechnology company developing first-in-class cell therapies with its unique Antibody-Cell Conjugation (ACC) platform technology to address gaps in cancer care, announced...

Rune Labs Secures FDA Clearance for Parkinson’s Disease Monitoring through StrivePD Ecosystem on Apple Watch

Rune Labs, a precision neurology company, announced its StrivePD software ecosystem for Parkinson's disease has been granted 510(k) clearance by the U.S. Food and...
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