FDA clears AI-powered application for measuring prostate volume

The FDA has cleared Clarius Mobile Health’s Clarius Prostate AI, an artificial intelligence application that measures prostate volume during handheld ultrasound examination, the company announced in a news release.¹

The app is also able to calculate PSA density by incorporating the patient’s PSA level and prostate volume.

Clarius Mobile Health said it will be demonstrating the application at the American Urological Association Annual Meeting in Las Vegas, Nevada.

"95% of clinicians we recently surveyed believe AI-powered measurements would save them time and allow them to see more patients. Manual ultrasound prostate volume measurements are repetitive and time-consuming, regardless of experience. With Clarius Prostate AI, what used to take several minutes now takes seconds, no matter your experience level,” said Sarah Leverett, the vice president of marketing at Clarius Mobile Health, in a news release.¹

The application is currently available for use with “Clarius handheld ultrasound scanners that are customized for urology exams, including the curvilinear C3 HD3 for transabdominal ultrasound, and the endocavitary EC7 HD3,” according to the company. Prostate AI users activate it within the Clarius App on a smartphone or tablet. The tool then highlights the prostate and then, once the image has been frozen, places calipers that can be fine-tuned manually. The app is also able to calculate prostate-specific antigen (PSA) density by incorporating the patient’s PSA level and prostate volume.

"We're excited about the potential of our AI-powered tools to enable more physicians, including primary care physicians, to use ultrasound to identify high risk prostate cancer patients sooner, without relying on a specialist referral," Leverett said in the release.¹

Clarius’ product portfolio also includes Bladder AI, which is used for measuring bladder volume.

REFERENCE

1. FDA clears new Clarius Prostate AI to help physicians assess and diagnose common urologic conditions in minutes. News release. Clarius Mobile Health. April 25, 2025. Accessed April 25, 2025. https://www.prnewswire.com/news-releases/fda-clears-new-clarius-prostate-ai-to-help-physicians-assess-and-diagnose-common-urologic-conditions-in-minutes-302437687.html