Elixir Medical’s DynamX Coronary Bioadaptor System Approved in Japan

September 15, 2026—Elixir Medical announced that Japan’s Ministry of Health, Labor, and Welfare has approved the DynamX coronary bioadaptor system for the treatment of coronary artery disease (CAD).

CASSINI-US Early Feasibility Study Begins for InnovHeart’s Saturn Transseptal TMVR System

September 14, 2026—InnovHeart announced the first United States implantation of the company’s Saturn transseptal transcatheter mitral valve replacement (TMVR) system.

CMS Initiates NCA on TAVR for Aortic Regurgitation

September 14, 2026—The Centers for Medicare & Medicaid Services (CMS) has initiated a national coverage analysis (NCA; CAG-00430R3) for transcatheter aortic valve replacement (TAVR) to treat aortic regurgitation (AR).

CMS Issues Final NCD on Coverage of TAVR for Severe Aortic Stenosis

September 14, 2026—The Centers for Medicare & Medicaid Services (CMS) issued the updated the National Coverage Determination (NCD) for transcatheter aortic valve replacement (TAVR).

Medtronic Makes Strategic Investment in Pi-Cardia

September 11, 2026—Medtronic and Pi-Cardia Ltd., a developer of leaflet modification technologies for structural heart disease, announced that Medtronic has made a strategic investment in Pi-Cardia.

IMDS NHanceIT Microcatheter for Complex PCI Launched in the United States 

September 11, 2026—Interventional Medical Device Solutions (IMDS) announced the United States launch of NHanceIT.

Emboliner Embolic Protection System Cleared by FDA for TAVR

September 10, 2026—Emboline, Inc. announced that the FDA has granted 510(k) clearance for the Emboliner embolic protection system to capture and remove embolic material during transcatheter aortic valve replacement (TAVR).

MicroPort’s FireShield Coronary Covered Stent System Enters China’s NMPA Special Review Procedure

September 4, 2026—MicroPort Coronary, a medical device company based in Shanghai, China, announced that its FireShield coronary covered stent system has been included in China’s National Medical Products Administration (NMPA) special review procedures for innovative medical devices (known as the “Green Channel”).