Aug. 24, 2026 — Tempus AI, Inc. has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for Tempus ECG-PH (pulmonary hypertension), an AI-enabled software device that analyzes ...
FDA
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Aug. 11, 2026 — Bracco Imaging recently announced that VueJect, its dedicated ultrasound contrast delivery system engineered to support cardiology imaging specifically, has received 510(k) clearance ...
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May 18, 2026 — AstraZeneca’s Baxfendy (baxdrostat) has been approved in the U.S. as a first-in-class aldosterone synthase inhibitor (ASI) for treating hypertension in combination with other ...
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May 1, 2026 — Philips has received FDA 510(k) clearance for its Smart Fit TorsoCardiac 1.5T coil, a lightweight and flexible MRI coil designed to support high-quality imaging while improving workflow ...
Sept. 2, 2026 — Heartvue.ai and Innolitics have announced the U.S. Food and Drug Administration has granted 510(k) ...
September 04, 2026
Aug. 25, 2025 — Abbott has received CE Mark in Europe for the Esprit BTK Everolimus Eluting Resorbable Scaffold ...
August 26, 2026
Aug. 24, 2026 — Tempus AI, Inc. has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for ...
August 24, 2026
Aug. 11, 2026 — Bracco Imaging recently announced that VueJect, its dedicated ultrasound contrast delivery system ...
August 11, 2026
July 29, 2026 — Caristo Diagnostics has announced that the U.S. Food and Drug Administration (FDA) has granted De Novo ...
July 30, 2026
July 28, 2026 — Implicity has been granted U.S. Food and Drug Administration (FDA) granted 510(k) clearance for its next ...
July 30, 2026
July 24, 2026 — MannKind Corp. recently announced that the U.S. Food and Drug Administration (FDA) has approved Furoscix ...
July 28, 2026
July 21, 2026 — ElectroWire Medical recently announced that the U.S. Food and Drug Administration (FDA) has granted 510 ...
July 23, 2026
July 8, 2026 — Conavi Medical Corp. has announced the publication of a case report in the Journal of the Society for ...
July 15, 2026
July 14, 2026 — Atrium Therapeutics, Inc. has announced that the U.S. Food and Drug Administration (FDA) has cleared its ...
July 14, 2026
July 7, 2026 — W. L. Gore & Associates’ medical business recently announced that the U.S. Food and Drug Administration ...
July 13, 2026
July 8, 2026 — Johnson & Johnson has announced that the U.S. Food and Drug Administration (FDA) approved the Dual Energy ...
July 08, 2026
June 29, 2026 — Laplace Interventional recently announced that the U.S. Food and Drug Administration (FDA) has approved ...
July 02, 2026
June 30, 2026 — Penumbra Inc. has received the CE Mark for Red 72 Silver Label and Red 72 Silver Label with SENDit ...
July 02, 2026
June 24, 2026 — BrightHeart has received the CE mark for its flagship medical devices, enabling commercialization of the ...
June 24, 2026