Jan. 13, 2026 – Innovative Health, Inc. has received its 50th clearance from FDA to reprocess single-use medical devices used in electrophysiology and cardiology labs. This latest clearance is to ...
FDA
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Jan. 12, 2026 — HeartLung Corp. has announced U.S. Food and Drug Administration (FDA) clearance of AI-CVD, its AI-powered quantitative imaging platform, under 510(k) K252029. With this clearance, AI ...
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Dec. 26, 2025 — Edwards Lifesciences has announced the company’s SAPIEN M3 mitral valve replacement system, a transcatheter therapy using a transseptal approach, has received U.S. Food and Drug ...
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Dec. 18, 2025 — Huxley Medical has announced the SANSA home sleep apnea test has received regulatory clearance from the United States Food and Drug Administration (FDA) to be used as a diagnostic ECG ...
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
Jan. 12, 2026 — HeartLung Corp. has announced U.S. Food and Drug Administration (FDA) clearance of AI-CVD, its AI ...
January 12, 2026
Jan. 6, 2026 — W. L. Gore & Associates’ medical business (Gore) has announced the FDA approval of the Gore Viabahn ...
January 06, 2026
Jan. 6, 2026 — Stereotaxis, a supplier of surgical robotics for minimally invasive endovascular intervention, has ...
January 06, 2026
Dec. 22, 2025 — Abbott recently announced the U.S. Food and Drug Administration (FDA) has approved the company's Volt ...
January 05, 2026
Dec. 26, 2025 — Edwards Lifesciences has announced the company’s SAPIEN M3 mitral valve replacement system, a ...
December 24, 2025
Dec. 18, 2025 — Huxley Medical has announced the SANSA home sleep apnea test has received regulatory clearance from the ...
December 19, 2025
Dec. 18, 2025 — Abbott has received U.S. Food and Drug Administration (FDA) clearance and CE Mark for its Amplatzer ...
December 18, 2025
Dec. 10, 2025 — HeartBeam, Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) ...
December 16, 2025
Dec. 15, 2025 — HeartSciences Inc., a healthcare information technology company advancing the use of ECG/EKGs through ...
December 16, 2025
Nov. 25, 2025 — Remington Medical has received U.S. Food and Drug Administration (FDA) 510(k) clearance and announced ...
December 09, 2025
Dec. 3, 2025 — Atraverse Medical, a medical device company developing next-generation left-heart access technology, has ...
December 05, 2025
Dec.1, 2025 – MannKind Corp. has announced that the U.S. Food and Drug Administration (FDA) has accepted the sNDA ...
December 01, 2025