Prodeon Medical announced that it received FDA 510(k) clearance for its Urocross expander system.
Sunnyvale, California-based Prodeon designed Urocross as a novel, non-permanent implant technology for treating lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH).
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It marks the latest device of this kind to pick up an FDA nod related to BPH. ProVerum and Zenflow announced FDA approvals for their implant-based technologies that treat BPH in December 2025. In January of this year, Butterfly Medical also said it completed the final 12-month follow-up for all patients in a study of its prostatic retraction device for BPH. Meanwhile, last week, robotic technology developer Procept launched its BPH-treating system internationally.
Prodeon designed Urocross for procedures that utilize commercially available cystoscopes. They place a non-permanent, nitinol implant designed to remodel the obstructed prostatic tissue. The implant is then retrieved within six months. Urocross requires no permanent placement and avoids damage to prostatic tissue, preserving future diagnostic and therapeutic options.
The company supported its 510(k) clearance with data demonstrating sustained improvements in urinary symptoms, quality of life and urinary flow after Urocross retrieval. Findings also included no negative impact on sexual function.
Thomas Palermo, President of Prodeon Medical, said:
“The FDA clearance of Urocross technology represents an important milestone for Prodeon and reflects our commitment to advancing therapies that balance durable symptom relief with patient and surgeon preferences. Unlike existing minimally invasive therapies that rely on permanent implants or irreversible tissue ablation, Prodeon Medical introduces a new category of non-permanent, retrievable intervention for BPH, designed to remodel obstructive tissue while leaving no permanent foreign material behind. We plan to initiate a controlled US commercial release of the Urocross system later this year, and are excited to bring this transformative technology to market, offering a solution that is designed to prioritize clinical efficacy, patient quality of life, and minimize future risks.”
