08:18 AM EDT, 05/14/2024 (MT Newswires) -- Profound Medical ( PROF ) said on Tuesday that it received 510(k) clearance from the Food and Drug Administration for the company's second TULSA-AI module, Contouring Assistant, for use with its TULSA-PRO system.
Contouring Assistant is a machine learning-based prostate segmentation tool designed to assist in delineating the prostate and target ablation volume. This module uses a large database of successful physician-created TULSA treatment designs and recommends a treatment design. As the TULSA treatment and outcomes database continues to grow via real-world adoption, and as AI technology evolves, the proposed treatment designs are expected to continue to improve, the company said.
Profound is a commercial-stage medical device company that develops and markets customizable, incision-free therapies for the ablation of diseased tissue.