Reflow Medical Spur Stent System Granted FDA De Novo Clearance

May 29, 2025—Reflow Medical, Inc. announced that the FDA has granted de novo clearance for the company’s Spur peripheral retrievable stent system for the treatment of de novo or restenotic lesions after predilatation in patients with infrapopliteal arterial disease.

BD Rotarex to Be Assessed in XTRACT Postmarket Registry

May 28, 2025—BD (Becton, Dickinson and Company) announced plans to initiate the XTRACT patient data registry for its Rotarex atherectomy system.

Siemens’ Somatom On.site Head CT Scanner Integrated Into Mobile Stroke Unit

May 28, 2025—Siemens Healthineers announced the introduction in the United States of a mobile stroke unit (MSU) featuring the company’s Somatom On.site head CT scanner with the first MSU deployed at UCLA Health in Los Angeles, California.

Terumo Interventional Systems Launches Roadsaver Carotid Stent System in Limited Market Release

May 27, 2025—Terumo Interventional Systems, a division of Terumo Corporation, announced the early commercial availability of its FDA-approved Roadsaver carotid stent system.

FDA Approves Phraxis EndoForce Connector for Endovascular Venous Anastomosis

May 22, 2025—Phraxis Inc. announced FDA approval of the EndoForce connector for endovascular venous anastomosis for dialysis access in patients with end-stage renal disease.

BD Reports Results from AV Fistula Cohort of Lutonix AV Global Registry

May 21, 2025—BD (Becton, Dickinson and Company) announced post hoc analysis results from the arteriovenous (AV) fistula cohort of the Lutonix Global AV Registry.

GE HealthCare CleaRecon DL for CBCT Imaging Launched in United States and Europe

May 21, 2025—GE HealthCare recently announced the launch of CleaRecon DL in the United States and European Union.

Route 92 HiPoint 88 Reperfusion System Cleared by FDA

May 21, 2025—Route 92 Medical, Inc. announced FDA 510(k) clearance (product code: NRY) for the company’s HiPoint reperfusion system, which includes the HiPoint 88 reperfusion system with the Tenzing 8 delivery catheter and featuring the Monopoint approach.

Epsilon’s EP-01 Endovascular EEG Device Granted FDA Breakthrough Device Designation

May 20, 2025—Japan-based Epsilon Medical Inc. announced that the FDA has granted Breakthrough Device designation for the company’s EP-01 endovascular electroencephalogram (EEG) device.

Merit Medical Acquires Biolife

May 20, 2025—Merit Medical Systems, Inc. announced that it has acquired Biolife Delaware, LLC. Under the merger transaction, Biolife has become a wholly owned subsidiary of Merit.