Regulatory Approvals

System creates 3D models of the heart with unprecedented anatomical details, allowing physicians to better plan and personalize therapeutic interventions  inHEART, a privately-held medical device...

The Rapid PE Triage & Notification tool analyzes CT pulmonary angiograms to find potential cases and alert care teams. RapidAI, a health tech company that...

CVRx, a developer of a neuromodulation device to treat the symptoms of heart failure, has received U.S. Food and Drug Administration (FDA) approval for magnetic...

Xact Robotics announced that it received FDA clearance for a modification to its Xact Ace robotic system for ablation procedures. Hingham, Massachusetts-based Xact Robotics’ FDA...

RadNet, Inc., announced that it has received FDA clearances for its DeepHeatlh Saige-DX™ mammography and Quantib® Prostate 2.0 MRI artificial intelligence ("AI") algorithms. Saige-DX: AI Mammography Diagnostic...

The Onyx Frontier™ drug-eluting stent offers an innovative delivery system and builds upon the acute performance and clinical data from the Resolute Onyx™ drug-eluting stent....

Paige,a global leader in clinical AI applications in pathology, announced it received CE-IVD and UKCA marks for the Paige Prostate Biomarker Suite, an AI...

MR 7700 imaging system features an enhanced gradient system for unmatched performance and precision, delivering Philips’ highest image quality to help improve diagnostic outcomesNewest...

CureApp, Inc. (Head Office: Chuo-ku, Tokyo; CEO: Kohta Satake) was notified by the Ministry of Health, Labour and Welfare on April 26, 2022 that...