The US Food and Drug Administration (FDA) has cleared Profound Medical’s AI-driven Contouring Assistant module for use in conjunction with its TULSA Pro prostate ablation system.

The TULSA Pro system can be used to perform the best transurethral ultrasound ablation (TULSA) procedure, which is the ablation of whole or partial-gland prostate tissue in patients with low, intermediate, or high-risk prostate cancer. The procedure can also be used in patients with benign prostatic hyperplasia (BPH).

Profound Medical describes the TULSA as an incision-free and radiation-free procedure that kills the targeted prostate tissue by gently heating the tissue using precise sound absorption technology. This allows for the preservation of urinary continence and sexual function while killing the affected tissue.

“The current clinical data shows that 20% of the time when you surgically remove the prostate, you are leaving some positive margins,” said Profound’s CEO Arun Menawat in an interview with Medical Device Network.

The AI module is a machine learning-based prostate segmentation tool, which can help to efficiently delineate the prostate and target ablation volume. The module also uses a “database formed from successful patients historically to be able to say this is where the margins should be to successfully treat this patient”, explained Menawat.

The FDA approval for the module was based on multiple studies showing that the AI Contouring Assistant was non-inferior to the Reference Standard but similar to expert radiologist interreader variability. Furthermore, the module reduces the surgery time by a third. Menawat added that the procedure being incision-free allows its administration across a wider patient pool including those with comorbidities such as diabetes.

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The use of AI has been increasing in clinical diagnostics, with radiology and imaging being the early adopters of the technology. GlobalData forecasts AI to be a key driver of medical device innovation. The AI market generated approximately $93bn in sales in 2023, as per GlobalData analysis.

The Contouring Assistant is the second of the Profound’s TULSA AI-assisted module that has received FDA clearance. In September 2023, the agency cleared an AI-assisted thermal boost module that allows surgeons to temporarily increase the ablation target temperature in prostate regions where advanced-stage cancer may be present.

Menawat added that with the AI infrastructure in place, Profound plans to apply for AI-assisted modules in additional urology indications, including BPH. In addition to expanding indications, the Canadian company also plans to expand territories such as Japan, China and India.