FDA Clears AI 'Contouring Assistant' in MRI-Guided Ultrasound Ablation Procedures

Reportedly built on over 24 million parameters drawn from nearly 7,500 training images, the artificial intelligence (AI) module Contouring Assistant has garnered 510(k) clearance from the Food and Drug Administration (FDA) for use in MRI-guided transurethral ultrasound ablation (TULSA) procedures in patients with prostate cancer.

Utilized in conjunction with Profound Medical’s TULSA-PRO system, the Contouring Assistant module offers machine learning-based segmentation of the prostate to facilitate targeted ablation of diseased tissue.

Profound Medical noted that the Contouring Assistant module was developed with a reference standard that combined contours from leading prostate radiologists Steven Raman, M.D., Robert Princethal, M.D., and Edward Steiner, M.D. Subsequent research evaluating the stand-alone capability of Contouring Assistant in 100 prostate cancer cases found it was non-inferior to the aforementioned reference standard, according to Profound Medical.

The company also noted that additional testing of the Contouring Assistant module by three urologists demonstrated a 32 percent reduction in the time it took to complete prostate segmentation.

“ … (Contouring) Assistant not only allowed my esteemed urologist colleagues and I to approach the accuracy of an expert radiologist reader in our TULSA treatment designs, but also enabled us to reduce overall procedure times by one-third,” noted Preston Sprenkle, M.D., an associate professor of urology at the Yale School of Medicine in New Haven, Ct.