Breakthrough Device Designation
Mar 14, 2024
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...
Read More...
Jan 25, 2024
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...
Read More...
Jan 04, 2024
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 ...
Read More...
Nov 30, 2023
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...
Read More...
Aug 03, 2023
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...
Read More...
-Agonist.png "Toll-like Receptors Agonist")
