Profound Medical 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.
Related: Freyja wins FDA clearance for VereSee device
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.
Profound Medical designed TULSA to employ real-time magnetic resonance (MR) guidance. It delivers pixel-by-pixel precision, preserving urinary continence and sexual function while killing the targeted tissue. The technology’s precise sound absorption technology gently heats the tissue to kill temperature in a one-and-done procedure. Profound Medical said in a news release that a single session takes just a few hours.
The Contouring Assistant AI module uses machine learning to segment the prostate, assisting in delineating the prostate and target ablation volume.
Profound Medical plans to continue working on the next TULSA-AI module, TULSA BPH. It expects more information on that later in 2024.
“The addition of a second, FDA-cleared TULSA-AI module is an important milestone as we continue to deliver on our promise to continuously improve the TULSA treatment experience for urologists and their patients,” said Arun Menawat, Profound Medical CEO and chair. “To that end, we believe that Contouring Assistant should not only increase urologists’ confidence in their treatment designs, but also significantly increase their procedural efficiency.”
