MedTech News
JBA AI Secures FDA Recognition for Software as a Medical Device (SaMD)
Regulatory Milestone Validates JBA AI’s Clinical-Grade Software for Advanced Diagnostic Support
Medtronic wins CE mark for VitalFlow ECMO system
A Medtronic (NYSE: MDT)+
official announced on social media that the company received CE mark for its VitalFlow system within its Cardiac Surgery portfolio.
BiVacor wins FDA breakthrough nod for Total Artificial Heart
BiVacor announced today that it received FDA breakthrough device designation for its Total Artificial Heart (TAH) system.
HistoSonics’ Edison System Approved for Early Market Access in Great Britain
Non-Invasive Histotripsy Technology Authorized Under Unmet Clinical Needs Pathway for Liver Tumor Treatment
Reflow Medical’s Spur® Stent System Receives FDA De Novo Clearance
First-of-its-Kind Retrievable Stent Gains Approval for Treating Challenging Below-the-Knee Peripheral Artery Disease
Diagnostic tool creates stronger, longer-lasting bioluminescence signals to detect viruses
Mass General Brigham researchers are shining a powerful new light into the viral darkness with the development of Luminescence CAscade-based Sensor (LUCAS), a rapid, portable, highly-sensitive diagnostic tool for processing complex biological samples.
Terumo launches Roadsaver carotid stent following FDA approval
Terumo Interventional Systems has announced the early commercial availability of its FDA-approved Roadsaver Carotid Stent System.
CoreMap wins FDA IDE for ablation mapping tech
CoreMap announced that it received FDA investigational device exemption (IDE) to extend its electrophysiology (EP) mapping trial to the U.S.