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FDA Clears Profound Medical’s AI Model for Treating Prostate Cancer


Profound Medical (Nasdaq: PROF) has received FDA 510(k) clearance for its second AI model aimed at treating prostate cancer. Profound Medical is a Toronto-based company, which specializes in developing and marketing customizable, non-invasive therapies for tissue ablation. The newly cleared AI model, called the Contouring Assistant, complements Profound Medical’s TULSA-Pro system, which is designed for transurethral ultrasound ablation (TULSA) procedures.

The TULSA procedure offers a treatment option for various stages of prostate cancer, including low, intermediate, and high-risk cases, as well as for patients with both prostate cancer and benign prostatic hyperplasia (BPH), men with only BPH, and those requiring salvage therapy for radio-recurrent localized prostate cancer. This technology utilizes real-time magnetic resonance (MR) guidance to precisely target and ablate diseased tissue while preserving urinary continence and sexual function. A single session of treatment can typically be completed in just a few hours.

The Contouring Assistant AI module employs machine learning to assist in segmenting the prostate by delineating the prostate and target ablation volume.

Looking ahead, Profound Medical is working on its next TULSA-AI module, TULSA BPH, with more information expected later in 2024. Arun Menawat, CEO and Chair of Profound Medical, views the clearance of the Contouring Assistant as an important milestone in fulfilling the company’s commitment to improving the TULSA treatment experience for both urologists and their patients. He anticipates that the new AI module will not only enhance urologists’ confidence in treatment designs but also significantly increase their procedural efficiency.



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