Regulatory Approvals

The US Food and Drug Administration (FDA) has issued 510k clearance for US Medical Innovations’s Canady Helios Cold Plasma (CHCP) Ablation System, a new...

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

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...

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, 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 (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...

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...