Regulatory Approvals

RapidAI Secures FDA Clearance for Perfusion Imaging in the Angiography Suite

RapidAI, the global leader in developing clinically deep Artificial Intelligence (AI) and technology workflow solutions to combat life-threatening neurovascular, cardiac, and vascular diseases, announced...

ZygoFix wins FDA clearance for zLock lumbar fixation system

ZygoFix today announced it received FDA 510(k) clearance for its zLock Lumbar Facet Fixation system. The Israel-based company said the milestone was supported by...

MCRA Supports Darmiyan with FDA Approval for BrainSee Device

MCRA, the leading privately held independent medical device, diagnostics, and biologics Clinical Research Organization (CRO) and advisory firm is pleased to announce its role in...

Toku bags breakthrough designation for kidney disease eye scan device

California-based Toku has seen its artificial intelligence (AI) system for identifying kidney disease awarded the US Food and Drug Administration (FDA) breakthrough device designation. The...

FDA clears Route 92 Medical’s FreeClimb 54 reperfusion system

Route 92 Medical announced it received FDA 510(k) clearance for its FreeClimb 54 reperfusion system. The FreeClimb54 system uses an aspiration catheter of the same...

Single Pass announces FDA clearance of its Kronos biopsy closure device

Single Pass, Inc. is proud to announce that its Class II Kronos biopsy closure device has received clearance from the U.S. Food and Drug Administration...

ClearPoint Neuro wins FDA clearance for neuro laser therapy accessory

ClearPoint Neuro (Nasdaq:CLPT) announced today that the FDA granted 510(k) clearance for its Prism bone anchor accessory.It marks the second new product introduction in...

FDA grants breakthrough designation to Roivios’s renal assist device

Roivios has secured the US Food and Drug Administration’s (FDA) breakthrough device designation for its JuxtaFlow renal assist device (RAD), designed to provide kidney...

FDA clears Sail Fusion’s BowTie Sacroiliac Fusion System

Sail Fusion today announced it received FDA 510(k) clearance for its BowTie Sacroiliac Fusion System. The Del Mar, California-based sacroiliac device company designed the device...
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