Lexology May 21, 2024
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...
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