Clarius Introduces FDA-Cleared Prostate AI for Handheld Ultrasound

Apr 27, 2025
Clarius Mobile Health has launched Clarius Prostate AI, an FDA-cleared tool for handheld ultrasound scanners, enabling quick prostate volume assessments.

Clarius Mobile Health has launched Clarius Prostate AI, an FDA-cleared tool designed to enhance the efficiency of prostate volume assessments during ultrasound exams. Announced in a press release, this AI-powered tool is the first of its kind available on a handheld ultrasound scanner, allowing primary care and urology physicians to perform assessments without the need for specialist referrals.

The Clarius Prostate AI tool automates the measurement of prostate volume, a critical factor in diagnosing conditions like Benign Prostatic Hyperplasia (BPH) and prostate cancer. This innovation reduces the time required for manual measurements from several minutes to mere seconds, regardless of the clinician's experience level. The tool is available with Clarius handheld ultrasound scanners, which offer high-definition imaging at a fraction of the cost of traditional systems.

Clinicians can activate the Prostate AI tool via the Clarius App on a smartphone or tablet, where it automatically highlights the prostate gland and places calipers to measure volume. The app also calculates PSA density, aiding in the early detection of prostate cancer. Clarius Prostate AI is part of the company's expanding AI portfolio, which includes other diagnostic tools like Bladder AI and Voice Controls.

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