FDA

FDA Grants De Novo Clearance for Reflow Medical’s Spur® Peripheral Retrievable Stent System

Reflow Medical, Inc., a leading developer of innovative medical devices focused on complex cardiovascular disease, announced that the U.S. Food and Drug Administration (FDA) has

May 30, 2025

MSKai Spine Imaging Software Receives FDA 510(k) Clearance for Clinical Use

Advanced software tool supports consistent, objective evaluation of lumbar spine MRI scans.

May 22, 2025

GC Biopharma Receives FDA Approval for its U.S. Plasma Collection Center in Calexico, California

With this approval, ABO Holdings is now operating all six plasma collection centers—two each in California, Utah, and New Jersey.

May 14, 2025

Carr Tech Corp Celebrates FDA 510(k) Class II Approval of FROG All-in-One Filter Needle

This transformative device advances safety and efficiency in drug preparation, underscoring the startup’s journey from solo founder to FDA-cleared innovator.

April 25, 2025

CereVasc’s eShunt® System Gains FDA Breakthrough Designation

“The recognition of Breakthrough Device Designation for the eShunt System in pediatric aged patients demonstrates the profound need for treatment innovation in this patient population and reinforces the potential safety and efficacy benefits that have already been observed with this minimally invasive, endovascular approach,” said Dan Levangie, Chairman & CEO of CereVasc, Inc. “We are encouraged and committed to making the eShunt System available to as many patients as possible living with this debilitating disease.”

April 23, 2025

Mursla Bio Receives FDA Breakthrough Device Designation for EvoLiver Test

Reflects the potential of EvoLiver test to improve early liver cancer detection among high-risk patients