FDA

News | Hemodynamic Monitoring Systems

FDA Breakthrough Device Designation Granted for Non-Invasive Central Venous Pressure Measurement System

Jan. 8, 2026 — Compremium AG recently announced that the U.S. Food and Drug Administration (FDA) has granted ...

January 13, 2026

News | FDA

FDA Clears HeartLung's Imaging Platform

Jan. 12, 2026 — HeartLung Corp. has announced U.S. Food and Drug Administration (FDA) clearance of AI-CVD, its AI ...

January 12, 2026

News | FDA

FDA Approves W.L. Gore Venous Stent

Jan. 6, 2026 — W. L. Gore & Associates’ medical business (Gore) has announced the FDA approval of the Gore Viabahn ...

January 06, 2026

News

Stereotaxis Interventional Ablation Catheter Gets FDA Nod

Jan. 6, 2026 — Stereotaxis, a supplier of surgical robotics for minimally invasive endovascular intervention, has ...

January 06, 2026

Abbott's PFAblation System Receives FDA Approval

News | FDA

Abbott's PFA System Receives FDA Approval

Dec. 22, 2025 — Abbott recently announced the U.S. Food and Drug Administration (FDA) has approved the company's Volt ...

January 05, 2026

News | Heart Valve Technology

Transcatheter Mitral Valve Replacement System Receives FDA Clearance

Dec. 26, 2025 — Edwards Lifesciences has announced the company’s SAPIEN M3 mitral valve replacement system, a ...

December 24, 2025

Home Sleep Apnea Test Receives FDA Clearance for Use as Diagnostic ECG Monitor

News | FDA

Home Sleep Apnea Test Gets FDA Clearance for Use as Diagnostic ECG Monitor

Dec. 18, 2025 — Huxley Medical has announced the SANSA home sleep apnea test has received regulatory clearance from the ...

December 19, 2025

News | FDA

Abbott's Amplatzer Piccolo Delivery System Receives FDA Clearance, CE Mark

Dec. 18, 2025 — Abbott has received U.S. Food and Drug Administration (FDA) clearance and CE Mark for its Amplatzer ...

December 18, 2025

News | FDA

HeartSciences Submits MyoVista wavECG Device for FDA Clearance

Dec. 15, 2025 — HeartSciences Inc., a healthcare information technology company advancing the use of ECG/EKGs through ...

December 16, 2025

News | FDA

Remington Medical’s Bluetooth-Enabled, Cordless Doppler Gets FDA Clearance

Nov. 25, 2025 — Remington Medical has received U.S. Food and Drug Administration (FDA) 510(k) clearance and announced ...

December 09, 2025

News | FDA

Atraverse Medical Secures FDA Clearance for Fully Integrated Transseptal Access System

Dec. 3, 2025 — Atraverse Medical, a medical device company developing next-generation left-heart access technology, has ...

December 05, 2025

News | FDA

FDA Reviewing 10-Second Treatment for Edema in Heart Failure

Dec.1, 2025 – MannKind Corp. has announced that the U.S. Food and Drug Administration (FDA) has accepted the sNDA ...

December 01, 2025

News | FDA

RapidAI Earns FDA Clearance for Rapid Aortic Product

Nov. 18, 2025 — RapidAI announced U.S. Food and Drug Administration (FDA) clearance of Aortic Management, part of the ...

November 18, 2025

News | FDA

FDA Grants 510(k) Clearance to Ultrasonic Surgical Aspirator System for Cardiac Surgeries

Nov. 11, 2025 -— Integra LifeSciences Holdings Corp. has announced the FDA 510(k) clearance for use of its CUSA Clarity ...

November 18, 2025

Stereotaxis’ Next-Gen Endovascular Surgical Robot Gets FDA Clearance

News | FDA

Stereotaxis’ Next-Gen Endovascular Surgical Robot Receives 510(k) Clearance from FDA

Nov. 10, 2025 — Stereotaxis has received U.S. Food and Drug Administration 510(k) clearance for its latest generation ...

November 11, 2025