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    Regulatory Approvals

    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...

    Intalight gains CE mark approval for DREAM OCT platform

    Ophthalmic technology developer Intalight has received the CE mark for its DREAM OCT platform, allowing the company to commercialise it within the European...
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