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

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LAS VEGAS, April 25, 2025 ~ Las Vegas, NV - Clarius Mobile Health, a leading company in AI-powered handheld ultrasound technology, has announced the launch of their latest product, Clarius Prostate AI. This FDA-cleared semi-automatic tool is designed to quickly and accurately calculate prostate volume during ultrasound exams. The company will be showcasing this new innovation at the American Urological Association annual meeting from April 26-29.

Prostate volume measurement is crucial in the assessment of common urologic conditions such as Benign Prostatic Hyperplasia (BPH) and prostate cancer. However, current measurement methods rely on manual processes using traditional ultrasound units. With the introduction of Clarius Prostate AI, primary care and urology physicians can now assess patients on the spot without having to wait for specialist referrals.

Sarah Leverett, Vice President of Marketing at Clarius, emphasizes the time-saving potential of AI for physicians who are facing high demand. "Our recent survey showed that 95% of clinicians believe that AI-powered measurements would save them time and allow them to see more patients," she says. "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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Clarius Prostate AI is currently available with Clarius handheld ultrasound scanners that are specifically designed for urology exams. These include the curvilinear C3 HD3 for transabdominal ultrasound and the endocavitary EC7 HD3 – the only FDA-cleared wireless ultrasound for transrectal imaging. These wireless and ultra-portable scanners offer high-definition imaging and performance similar to traditional ultrasound systems but at a fraction of the cost.

During an exam, clinicians can easily activate Prostate AI with a simple tap in the Clarius App on their smartphone or tablet. The tool automatically highlights the prostate gland and places calipers to measure volume when the image is frozen. Clinicians can also manually adjust the calipers for more precise measurements. Additionally, the app calculates PSA density using the entered PSA value and measured volume, allowing for earlier and more informed detection of prostate cancer.

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Clarius Prostate AI is just one of the many AI-powered tools offered by Clarius, including Bladder AI and Voice Controls. These tools are available with a Clarius Membership or One-Time License and come with specialized imaging presets, built-in patient reports, and integrated billing codes to streamline workflow in private practice.

"We are 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," says Sarah Leverett.

Clinicians who are members of Specialty Networks and Afaxys can take advantage of pre-negotiated special pricing and terms for Clarius Prostate AI. This new tool is set to revolutionize prostate volume measurement and improve patient care in urology practices across the country.
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