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."

Clarius Prostate AI is available now with Clarius handheld ultrasound scanners that are customized for urology exams, including the curvilinear C3 HD3 for transabdominal ultrasound, and the endocavitary EC7 HD3, which is the only FDA-cleared wireless ultrasound for transrectal imaging. Wireless and ultra-portable, Clarius ultrasound scanners deliver the high-definition imaging and performance of a traditional ultrasound system for a third of the cost.

During an exam, clinicians can activate Prostate AI with a tap in the Clarius App on a smartphone or tablet. The tool automatically highlights the prostate gland and, when the image is frozen, places calipers to measure volume. Clinicians can fine-tune the calipers manually for precision. The app also calculates PSA density using the entered PSA value and measured volume—supporting earlier, more informed detection of prostate cancer.

Clarius Prostate AI is part of the growing Clarius AI portfolio, which includes tools like Bladder AI and Voice Controls. All models are available with a Clarius Membership or One-Time License, and include specialized imaging presets, built-in patient reports, and integrated billing codes to streamline workflow in private practice.

"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," Sarah Leverett adds.

Clinicians who are members of Specialty Networks and Afaxys can take advantage of pre-negotiated special pricing and terms.

About Clarius Mobile Health 
Clarius is on a mission to make accurate, easy-to-use, and affordable ultrasound tools available to all medical professionals in every specialty. With decades of experience in medical imaging, the team knows that great ultrasound imaging improves confidence and patient care. Today, AI-powered Clarius handheld wireless ultrasound scanners connect to iOS and Android devices, delivering high-resolution ultrasound images traditionally only available with bulkier, high-end systems at a fraction of the cost. Almost 5 million high-definition scans have been performed using Clarius wireless handheld scanners. Clarius scanners are available in over 90 countries worldwide. Learn more at www.clarius.com. 

Clarius Media Contact 
Sarah Leverett
Vice President of Marketing | Clarius Mobile Health
Phone: +1 (206) 550-6120
Email: [email protected] 

SOURCE Clarius Mobile Health