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Breakthrough Device Designation

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MedTech News for Allumiqs, MangoRx, Ventris
Allumiqs and Prolytix’s Partnership; Setpoint Medical’s Neuroimmune Modulation Platform gets FDA Breakthrough Designation; MangoRx Launches ‘PRIME’ with FDA-approved TRT; SeaStar Medical Updates Quelimmune Commercial Launch; Ventris Medical Gains 510(k) for Amplify® Bone Graft Putty

MangoRx Officially Launches ‘PRIME’ by MangoRx, Powered by Kyzatrex®️ FDA Approved Oral Testosterone Replacement Therapy (TRT) Treatment On March 12, 2024, Mangoceuticals, Inc. unveiled a groundbreaking development eagerly awaited by many: the launch of 'PRIME' by MangoRx, Powered by Kyzatrex®️. This release mar...

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MedTech News for AngioDynamics, Enhatch, AbSolutions
FDA Breakthrough Device Designation to Pi-Cardia’s ShortCut; AbSolutions Med’s REBUILD Bioabsorbable Abdominal Wall Closure Device; AngioDynamics Announces FDA 510(k) Clearance of Auryon XL Radial Access Catheter; Enhatch Announces FDA Clearance for a TKA Patient-Specific Instrumentation System

Pi-Cardia Receives FDA Breakthrough Device Designation for ShortCut™ Pi-Cardia Ltd., a prominent player in advancing catheter-based leaflet modification solutions for heart valve treatment, revealed that its ShortCut™ device has attained Breakthrough Device Designation from the US Food and Drug Administration. S...

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MedTech News for Enovis, AnX Robotica, CGBio
HR Pharmaceuticals Announced Collaboration with Poiesis Medical; Enovis Acquired Lima Corporate; AnX Robotica Announced FDA Clearance for ProScan; FDA Breakthrough Device Designation for CGBio’s ‘NOVOSIS PUTTY’; EndoSound Received 510(k) Clearance for Breakthrough EVS Innovation; Boston Scientific Initiated AVANT GUARD Clinical Trial

HR Pharmaceuticals, Inc. Received Exclusive Commercialization Rights to Poiesis Medical’s Dual Balloon Catheter Technology in North America On December 28, 2023, HR Pharmaceuticals entered into a collaboration with Poiesis Medical LLC, to license Poiesis's Dual Balloon Catheter (Duette™). According to the terms ...

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MedTech News for BrainSpec, Revvity, FormaPath, Pramand
Baird Medical’s Microwave Ablation System; BrainSpec’s AI-Backed Solution for Non-Invasive Brain Chemistry Measurement; AWAK’s AI-Enabled Kidney Disease Prediction Tool; Revvity’s EONIS Q System; FormaPath Announced Advancement in Cancer Pathology; Pramand Launched CraniSeal Dural Sealant

Baird Medical Received the US FDA Clearance for a Microwave Ablation System On November 22, 2023, Baird Medical announced the US Food and Drug Administration clearance of the company’s microwave ablation (MWA) system and disposable needles for use in the US. The clearance allows the use of the technology to a...

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MedTech News for icotec, Terumo, Genesis
Icotec’s VADER Pedicle System; Terumo BCT’ Reveos Automated Whole Blood Processing System; Genesis MedTech’s J-Valve Transfemoral System; STARmed Launched STARmed America in the USA

Genesis MedTech Announces FDA Breakthrough Device Designation for the J-Valve™ Transfemoral System Genesis MedTech, a leading medical device company, announced that the US Food and Drug Administration (FDA) has designated its J-ValveTM Transfemoral (TF) System as a Breakthrough Device. This innovative heart valv...

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