Profound Medical (NASDAQ:PROF; TSX:PRN) announced that it has received FDA 510(k) clearance for its second TULSA-AI module, Contouring Assistant, a machine learning-based prostate segmentation tool, for use in conjunction with the TULSA-PRO system. This tool is designed to assist in efficiently delineating the prostate and target ablation volume.
In support of the FDA 510(k) application, Contouring Assistant underwent rigorous analysis and was validated in two clinical studies.
In a statement, Arun Menawat, Ph.D., CEO and Chairman of Profound Medical, said that the addition of a second, FDA-cleared TULSA-AI module is an important milestone as the company continues to deliver on its promise to continuously improve the TULSA treatment experience for urologists and their patients. “We believe that Contouring Assistant should not only increase urologists’ confidence in their treatment designs, but it will significantly increase their procedural efficiency.”
The TULSA procedure, performed using Profound’s TULSA-PRO system, employs real-time MR guidance for precision to preserve prostate disease patients’ urinary continence and sexual function while killing the targeted prostate tissue via a precise sound absorption technology that gently heats it to kill temperature (55°C). TULSA is an incision- and radiation-free “one-and-done” procedure performed in a single session that takes a few hours. No hospital stay is required, and most TULSA patients report quick recovery to their normal routine.
Profound is continuing development work on the next planned TULSA-AI module, TULSA BPH, and expects to provide more details later in 2024.
