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FDA Clears New Clarius Prostate AI

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.

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.