FDA Clears New Clarius Prostate AI To Help Physicians Assess and Diagnose Common Urologic Conditions in Minutes

Clarius is the first to offer an FDA-cleared AI-powered prostate measurement tool on a handheld ultrasound scanner—empowering primary care and urology physicians to assess patients on the spot without waiting for specialist referrals

LAS VEGAS, April 25, 2025 /PRNewswire/ — Clarius Mobile Health, a pioneer in AI-powered handheld ultrasound, is introducing Clarius Prostate AI, an FDA cleared semi-automatic tool that quickly and accurately calculates prostate volume during an ultrasound exam. Measuring prostate volume is essential for assessing increasingly common urologic conditions such as Benign Prostatic Hyperplasia (BPH) and prostate cancer. Current measurement methods rely on manual processes using traditional ultrasound units. Clarius is demonstrating Prostate AI at the American Urological Association annual meeting in Las Vegas from April 26-29. 

Sarah Leverett, Vice President of Marketing at Clarius, highlights the time-saving potential of AI for physicians facing high demand: “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.”

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