JBA AI Secures FDA Recognition for Software as a Medical Device (SaMD)
June 9, 2025
Regulatory Milestone Validates JBA AI’s Clinical-Grade Software for Advanced Diagnostic Support
Regulatory Milestone Validates JBA AI’s Clinical-Grade Software for Advanced Diagnostic Support
A Medtronic (NYSE: MDT)+
official announced on social media that the company received CE mark for its VitalFlow system within its Cardiac Surgery portfolio.
This tiny device can shrink dangerous blood clots. It’s called the ‘milli-spinner’ and its invention was partly an accident.
BiVacor announced today that it received FDA breakthrough device designation for its Total Artificial Heart (TAH) system.
Non-Invasive Histotripsy Technology Authorized Under Unmet Clinical Needs Pathway for Liver Tumor Treatment
First-of-its-Kind Retrievable Stent Gains Approval for Treating Challenging Below-the-Knee Peripheral Artery Disease
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 Interventional Systems has announced the early commercial availability of its FDA-approved Roadsaver Carotid Stent System.
CoreMap announced that it received FDA investigational device exemption (IDE) to extend its electrophysiology (EP) mapping trial to the U.S.
Advanced AI-Powered Chest X-ray Solution Expands Diagnostic Precision and Gains European Regulatory Approval.