Butterfly Medical secures EU MDR certification for its next-generation benign prostatic hyperplasia (BPH) treatment device. The certification validates compliance with Europe’s strict medical device safety and performance regulations. This milestone supports broader market access and adoption of the company’s innovative urological solution.
Butterfly Medical raises **$21 million** in upsized Series C funding to develop a **minimally invasive treatment for benign prostatic hyperplasia (BPH)**. The capital accelerates FDA regulatory approval and supports global commercialization efforts. The company will also showcase its technology at the **AUA 2026** conference.
Butterfly Medical finishes a 244-patient clinical trial evaluating its minimally invasive therapy for benign prostatic hyperplasia (BPH). The study results will underpin the company’s upcoming FDA Pre-Market Approval (PMA) submission. The procedure aims to provide an alternative to traditional surgical interventions for BPH patients.
Butterfly Medical shares new clinical findings on its minimally invasive device for benign prostatic hyperplasia (BPH) treatment. The data, drawn from pilot and long-term studies, will be presented at the American Urological Association (AUA) 2025 conference. The presentation consolidates early and sustained efficacy observations for the device.