March 24, 2026 — Anumana has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its pulmonary hypertension (PH) algorithm, an AI-enabled software-as-a-medical-device (SaMD) that ...
FDA
-
-
March 25, 2026 — Royal Philips has launched its intuitive interventional guidance platform, IntraSight Plus, which is cleared for clinical use in the U.S. and Europe. With CE marking and FDA 510(k) ...
-
March 6, 2026 — Building on its leadership in cardiac MR, Philips has received FDA 510(k) clearance for SmartHeart, an AI-powered cardiac MR planning solution designed to simplify one of the most ...
-
Feb. 2, 2026 — Brainomix, a provider of AI-powered imaging tools in stroke and lung fibrosis, is introducing its new Brainomix 360 Next Generation platform at the International Stroke Conference (ISC) ...
April 15, 2026 – AliveCor has received CE Mark (Conformité Européenne) for the Kardia 12L electrocardiogram (ECG) System ...
April 15, 2026
April 7, 2026 —TRiCares SAS has received approval from the U.S. Food and Drug Administration (FDA) for an ...
April 09, 2026
April 8, 2026 — Anumana, Inc. recently announced U.S. Food and Drug Administration (FDA) clearance of its ECG-AI ...
April 08, 2026
March 31, 2026 — Solo Pace Inc. has announced the commercial release of the SoloPace Fusion Temporary Pacing System. The ...
April 03, 2026
March 24, 2026 — Anumana has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its pulmonary ...
March 31, 2026
March 25, 2026 — Royal Philips has received U.S. Food and Drug Administration (FDA) 510(k) clearance for EchoNavigator ...
March 27, 2026
March 25, 2026 — Royal Philips has launched its intuitive interventional guidance platform, IntraSight Plus, which is ...
March 26, 2026
March 23, 2026 —Medtronic plc has received U.S. Food and Drug Administration (FDA) approval for an expanded indication ...
March 24, 2026
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