Regulatory Approvals

BiVacor wins FDA breakthrough nod for Total Artificial Heart

BiVacor announced it received FDA breakthrough device designation for its Total Artificial Heart (TAH) system. The designation supports the TAH as a bridge to transplant...

CoreMap wins FDA IDE for ablation mapping tech

CoreMap received FDA investigational device exemption (IDE) to extend its electrophysiology (EP) mapping trial to the U.S. The study aims to evaluate the safety and...

Distalmotion wins FDA nod for gallbladder removal with surgical robot

Distalmotion announced it received FDA 510(k) clearance for the use of its Dexter surgical robot in adult cholecystectomy (gallbladder removal). Lausanne, Switzerland–based Distalmotion already holds...

Reflow Medical wins De Novo clearance for Spur Retrievable Stent System

Reflow Medical, Inc., one of the leading developer of innovative medical devices focused on complex cardiovascular disease, announced that the U.S. Food and Drug...

AnX Robotica wins FDA nod for next-gen gastrointestinal motility capsule

AnX Robotica announced today that it received FDA 510(k) clearance for its MotiliCap technology with MotiliScan companion software. The company said in a news release...

Route 92 Medical wins FDA nod for reperfusion system, reports positive study findings

Route 92 Medical announced its HiPoint Reperfusion System, including the .088in HiPoint 88 aspiration catheter, has shown positive outcomes in the SUMMIT MAX trial...

Hyalex Orthopaedics’ knee implant trial application gains FDA approval

Hyalex Orthopaedics’ supplemental investigational device exemption (IDE) application has received approval from the US Food and Drug Administration (FDA) for a clinical trial of...

Atia Vision received FDA investigational device exemption to study OmniVu lens system

Atia Vision received FDA investigational device exemption (IDE) approval to study its OmniVu lens system. The Shifamed portfolio company can now begin a traditional feasibility...

Gradient Denervation Technologies wins FDA Breakthrough Device Designation

Gradient Denervation Technologies announced its pulmonary denervation system has received Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA). This program creates...
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