Dec.1, 2025 – MannKind Corp. has announced that the U.S. Food and Drug Administration (FDA) has accepted the sNDA seeking approval for FUROSCIX ReadyFlow Autoinjector (SCP-111), developed to deliver a ...
FDA
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Nov. 18, 2025 — RapidAI announced U.S. Food and Drug Administration (FDA) clearance of Aortic Management, part of the Rapid Aortic product, a comprehensive deep clinical AI solution designed to ...
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Nov. 11, 2025 -— Integra LifeSciences Holdings Corp. has announced the FDA 510(k) clearance for use of its CUSA Clarity Ultrasonic Surgical Aspirator System for cardiac surgeries. The recent clearance ...
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Nov. 10, 2025 — Stereotaxis has received U.S. Food and Drug Administration 510(k) clearance for its latest generation robotic system, GenesisX. GenesisX is the latest advance in endovascular surgical ...
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
Nov. 18, 2025 — RapidAI announced U.S. Food and Drug Administration (FDA) clearance of Aortic Management, part of the ...
November 18, 2025
 Nov. 11, 2025 -— Integra LifeSciences Holdings Corp. has announced the FDA 510(k) clearance for use of its CUSA Clarity ...
November 18, 2025
Nov. 10, 2025 — Stereotaxis has received U.S. Food and Drug Administration 510(k) clearance for its latest generation ...
November 11, 2025
Oct. 29, 2025 — Circle Cardiovascular Imaging Inc., a provider of cardiovascular imaging solutions, recently announced ...
November 03, 2025
Oct. 24, 2025 —YorLabs, Inc., a medical technology company developing next-generation intracardiac imaging solutions for ...
October 27, 2025
Oct. 21, 2025 — SpectraWAVE, Inc., a medical imaging company focused on improving the treatment and outcomes for ...
October 24, 2025
Oct. 22, 2025 — Qure has announced its latest (510) K clearance from the US Food and Drug Administration (FDA).Â
The ...
October 23, 2025
Oct. 16, 2025 — Thirona recently announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance ...
October 16, 2025
Oct. 15, 2025 — Stereotaxis recently announced it has obtained CE Mark in Europe and submitted a 510(k) application to ...
October 16, 2025
Oct. 14, 2025 — Nurea has announced that its PRAEVAorta 2 software has received FDA 510(k) clearance, enabling entry ...
October 14, 2025
Oct. 13, 2025 — Medtronic plc recently announced it has received U.S. Food and Drug Administration (FDA) labeling ...
October 13, 2025
Oct. 7, 2025 — Nobles Medical Technology II, a provider of  cardiovascular closure solutions, has announced that the U.S ...
October 07, 2025