March 23, 2026 —Medtronic plc has received U.S. Food and Drug Administration (FDA) approval for an expanded indication ...
FDA
March 10, 2026 — HeartHero has announced that its Premarket Approval (PMA) application for Elliot, the company’s ...
March 10, 2026
March 6, 2026 — Building on its leadership in cardiac MR, Philips has received FDA 510(k) clearance for SmartHeart, an ...
March 09, 2026
Feb. 27, 2026 — The U.S. Food and Drug Administration (FDA) has approved Abbott’s CardioMEMS Hero device — a pulmonary ...
February 27, 2026
Feb. 26, 2026 — The U.S. Food and Drug Administration (FDA) has given 510(k) class II clearance of qXR-Detect, the ...
February 26, 2026
Feb. 17, 2026 — The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for Retia Medical's Argos ...
February 17, 2026
Dec. 10, 2025 — The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to HeartBeam, Inc. for its 12 ...
February 16, 2026
Feb. 2, 2026 — Brainomix, a provider of AI-powered imaging tools in stroke and lung fibrosis, is introducing its new ...
February 02, 2026
Feb. 2, 2026 — GE HealthCare has announced that Allia Moveo has received U.S. Food and Drug Administration (FDA) 510(k) ...
February 02, 2026
Jan. 27, 2026 — Cytokinetics, Inc. has announced that Myqorzo (aficamten) is now available for prescription in 5 mg, 10 ...
January 28, 2026
Jan. 20, 2026 — Abbott has received CE Mark in Europe for the TactiFlex Duo Ablation Catheter, Sensor Enabled to treat ...
January 22, 2026
Jan. 6, 2026 — UltraSight, a provider of AI-guided cardiac imaging workflows, has announced FDA clearance to expand its ...
January 16, 2026
Jan. 13, 2026 – Innovative Health, Inc. has received its 50th clearance from FDA to reprocess single-use medical devices ...
January 15, 2026
Jan. 8, 2026 — AccurKardia recently announced U.S. Food and Drug Administration (FDA) 510(k) clearance and the ...
January 15, 2026
Jan. 13, 2026 — AliveCor has received U.S. Food and Drug Administration (FDA) clearance for the next generation of KAI ...
January 14, 2026