Butterfly Medical Achieves EU MDR Certification for Next-Generation BPH Treatment

Milestone Demonstrates Compliance with Rigorous European Regulatory Standards for Medical Device Safety and Performance

BOSTON and YOKNEAM, Israel, Oct. 13, 2026 /PRNewswire/ -- Butterfly Medical, developer of a proprietary minimally invasive solution for benign prostatic hyperplasia (BPH), today announced that it has received certification under the European Union Medical Device Regulation (EU MDR 2017/745) for the Butterfly Prostatic Retraction Device.

This significant regulatory milestone follows Butterfly Medical's completion of its 244-patient pivotal clinical trial and the submission of its Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA). 

"Securing EU MDR certification is a major milestone for Butterfly Medical," said Patrick MacCarthy, CEO. "This achievement reflects years of clinical studies and quality system development, reinforcing our commitment to meeting rigorous regulatory standards."

The Butterfly Prostatic Retraction Device is an anatomically designed implant intended to relieve urinary symptoms associated with BPH. Designed to bridge the gap between pharmaceutical therapies and invasive surgical procedures, the device is intended to improve urinary flow without cutting, burning, or removing tissue and does not require  the purchase of dedicated capital equipment.

"This certification represents an important step toward expanding treatment options for men living with BPH," said Dr. James C. Ulchaker, Chief Medical Officer for Butterfly Medical and Emeritus Urologist at the Cleveland Clinic. "BPH affects men differently, and patients deserve treatment options that address their individual needs and preferences, including the desire to avoid tissue ablation or long-term medication."

Butterfly Medical will present a company update at the 2026 AdvaMed MedTech Conference on Tuesday, October 20, at 9:15 a.m. ET on the Innovation Pavilion Stage at the Thomas M. Menino Convention & Exhibition Center in Boston.

About Butterfly Medical

Butterfly Medical™ is a medical device company committed to reshaping the treatment of benign prostatic hyperplasia (BPH) through its innovative, minimally invasive solution. The company's flagship product is designed to improve urinary flow and provide relief from BPH symptoms, thereby improving patients' quality of life. By offering an alternative to both medication and conventional BPH surgery, Butterfly Medical aims to expand treatment options for millions of men worldwide.

The Butterfly Prostatic Retraction Device is CE Mark certified under EU MDR but has not yet received FDA approval for commercial use in the United States.  As with other BPH interventions, potential risks associated with the Butterfly procedure include urinary discomfort, urgency, frequency, bleeding, and the possible need for device removal.

For more information, visit: https://butterfly-medical.com/. Follow Butterfly Medical on LinkedIn.

Media Contact:
Jessica Hoffman
FINN Partners for Butterfly Medical
[email protected]
+1-929-588-2012

SOURCE Butterfly Medical