FDA Clears Tempus ECG-MR AI Software for Identifying Undiagnosed Mitral Regurgitation

October 30, 2026—Tempus AI, Inc. announced it received FDA 510(k) clearance for Tempus ECG-MR, an artificial intelligence (AI-) software product that analyzes standard 12-lead resting electrocardiograms (ECGs) to detect signs associated with undiagnosed moderate or severe mitral regurgitation (MR).

AMA Advances Framework for Clinical AI Liability

October 30, 2026—The American Medical Association (AMA) announced that its Center for Digital Health and Artificial Intelligence (AI) is advancing a new framework for aligning liability in clinical care with each party’s (developers and manufacturers; health care organizations and other deployers; physicians; and patients) authority and ability to prevent or mitigate harm.

Rampart Launches Vanguard Total-Body Radiation Protection for Interventional Imagers

October 29, 2026—Rampart announced the launch of Vanguard, a radiation protection solution designed for interventional imagers working at the head of the table.

IDE Approved for Vincora’s EFS of Nexus Chordal Repair System

October 29, 2026—Vincora (NeoChord, Inc. d/b/a Vincora) announced that the FDA has approved an investigational device exemption to initiate a United States early feasibility study of Nexus, the company’s investigational transcatheter chordal repair system for the treatment of degenerative mitral valve regurgitation.

Abbott’s Amplatzer Paraclose PVL Occluder Approved by FDA

October 29, 2026—Abbott announced it has received FDA approval for the Amplatzer Paraclose paravalvular leak (PVL) occluder.

CROWN-MV Pivotal Trial Begins for Abbott’s Cephea Device for Mitral Valve Disease

October 29, 2026—Abbott announced it has initiated the CROWN-MV pivotal trial evaluating the safety and effectiveness of the company’s investigational Cephea mitral valve system in treating patients with symptomatic mitral valve disease who are not candidates for surgery and transcatheter repair.

Siemens’ Ultrasound Business Shifts Focus to Procedural Imaging and Image-Guided Therapy

October 28, 2026—Siemens Healthineers announced the strategic focus of its ultrasound business is shifting to procedural imaging and image-guided therapy.

AdvaMed Submits Recommendations to CMS to Strengthen RAPID Coverage Pathway

October 27, 2026—AdvaMed, the Advanced Medical Technical Association, announced it recommended refinements to the Centers for Medicare & Medicaid Services (CMS) that the agency could make to help its proposed Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway deliver more timely access to breakthrough medtech for Medicare beneficiaries.