FDA

Stereotaxis to Demo GenesisX Robotic System at HRS

April 21, 2025 — Stereotaxis, a provider of surgical robotics for minimally invasive endovascular intervention, will ...

April 21, 2025

News | Imaging Software Development

FDA Grants Clearance for AI-powered Cardiac Imaging Software

April 15, 2025 – DESKi recently announced FDA clearance for HeartFocus, its AI-enabled heart exam software that empowers ...

April 15, 2025

News | Hypertension

FDA Approves Updated Label for Tryvio (aprocitentan)

April 9, 2025 — Idorsia Ltd recently announced that the US Food & Drug Administration (FDA), after having released ...

April 09, 2025

News | Atrial Fibrillation

CardioVia Receives FDA Clearance for Minimally Invasive Heart-Surface Treatment

April 7, 2025 — CardioVia, a medical device company specializing in advanced cardiac care solutions, has received U.S ...

April 08, 2025

News | Heart Failure

FDA Accepts, Grants Priority Review Designation for Bayer's msNRA for Patients with Heart Failure

March 17, 2025 — Bayer recently announced that the U.S. Food and Drug Administration (FDA) accepted its supplemental new ...

March 21, 2025

News | Thrombectomy Devices

Imperative Care Expands Precision Thrombectomy Portfolio

March 24, 2025 — Imperative Care, Inc. recently announced U.S. Food and Drug Administration (FDA) 510(k) clearance of ...

March 24, 2025

News | Computed Tomography (CT)

AI Image Analysis App Receives FDA 510(k) Clearance

March 11, 2025 — Caristo Diagnostics has received U.S. Food and Drug Administration (FDA) 510(k) clearance of its CaRi ...

March 11, 2025

News | Stroke

FDA Approves Clot-Dissolving Agent for Acute Ischemic Stroke in Adults

March 3, 2025 — Genentech, a member of the Roche Group, recently announced that the U.S. Food and Drug Administration ...

March 04, 2025

News | PET Imaging

Patients Undergo First Doses of New Cardiac PET tracer

Feb. 25, 2025— GE HealthCare has delivered the first patient doses of Flyrcado (flurpiridaz F 18) injection, a unit dose ...

March 03, 2025

News | Artificial Intelligence

Riverain Technologies Launches New FDA-Cleared Technology, Expands Globally

Feb. 4, 2025 — Riverain Technologies recently announced it expanded across eight countries in 2024 and added nearly 50 ...

February 04, 2025

News

Roche's Lp(a) Gen.2 Molarity Assay Receives FDA Clearance

January 29, 2025 – Roche announced today that the Tina-quant Lipoprotein (a) Gen.2 Molarity assay has received 510(k) ...

February 03, 2025

News | Artificial Heart

Realheart TAH Receives Humanitarian Use Device Designation from FDA

Jan. 29, 2025 – Scandinavian Real Heart AB (recently aannounced that its total artificial heart, Realheart TAH, has been ...

January 30, 2025

News | Interventional Radiology

Instylla Receives FDA Clearance for Embolic System

Jan. 28, 2025 — Instylla, Inc., a privately held clinical-stage company developing solutions for peripheral vascular ...

January 29, 2025

News | Hypertension

Mineralys Therapeutics Announces Phase 2 Clinical Trial of Lorundrostat

Jan. 8, 2025 — Mineralys Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on developing medicines ...

January 08, 2025

News | Heart Failure

Fire1 System Receives FDA Breakthrough Device Designation

Jan. 7, 2025 — FIRE1 recently announced it has received Breakthrough Device Designation from the U.S. Food and Drug ...

January 07, 2025