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Profound Medical wins FDA clearance for AI to support prostate cancer procedure

Profound Medical (Nasdaq:PROF) announced today that it received FDA 510(k) clearance for its second AI model for treating prostate cancer.

Toronto-based Profound Medical develops and markets customizable, incision-free therapies for the ablation of diseased tissue. Its latest clearance covers the second TULSA-AI module, the Contouring Assistant. It works in conjunction with the company’s TULSA-Pro system.

The TULSA (transurethral ultrasound ablation) procedure offers a treatment for low- intermediate- or high-risk prostate cancer. It also extends to hybrid patients with both prostate cancer and benign prostatic hyperplasia (BPH), men with BPH only and patients requiring salvage therapy for radio-recurrent localized prostate cancer.

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