Israeli Medical Device Startup Receives European CE Marking
November 27, 2017 | Israeli medical device startup Butterfly Medical has received European CE approval for its its non-surgical, office-based treatment of Benign Prostate Hyperplasia (BPH). According to the European Commission, the letters ‘CE’ appear on many products traded on the extended Single Market in the European Economic Area (EEA). They signify that products sold in the EEA have been assessed to meet high safety, health, and environmental protection requirements. The solution expands treatment options for BPH sufferers, by providing a simple, fast, and minimally invasive, in-office procedure that is an alternative to drug treatment or surgery, a statement from the company said. The device is designed to dilate the prostatic urethra without surgical incision or prostate tissue removal. The device’s design secures to the prostate tissue and prevents migration. It moves the obstructing lobes of the prostate to improve urine flow. The procedure is performed in the comfort of the physician’s office under local anesthesia and can take as little as 10 minutes. Butterfly Medical was founded in 2014 by Dr. Adrian Paz and Yehuda Bachar.