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).
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.