Clarius Mobile Health is launching Clarius Prostate AI, a semiautomatic tool that calculates prostate volume during an ultrasound exam.
The company is showcasing Prostate AI at the American Urological Association (AUA) annual meeting in Las Vegas, NV, from April 26 to 29. The tool has secured 501(k) clearance from the U.S. Food and Drug Administration (FDA).
Clarius Prostate AI measures prostate volume from ultrasound exams.Clarius Mobile Health
Clarius Prostate AI is available now with Clarius handheld ultrasound scanners that are customized for urology exams. 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 adjust the calipers manually for precision. The app also calculates prostate-specific antigen (PSA) density using the entered PSA value and measured volume.
As part of the company's AI portfolio, Clarius Prostate AI is available with a Clarius membership or one-time license. Clarius said this includes specialized imaging presets, built-in patient reports, and integrated billing codes.
![A normal mammogram confirmed by three-year radiologic follow-up illustrates reader-marked regions of interest (ROIs) during (A) unaided (round 1) and (B) artificial intelligence (AI)–assisted (round 2) reading. Each colored dot represents an ROI for recall by a human reader. Readers could mark more than one ROI per case, represented by multiple dots of the same color. During AI-assisted reading, the AI system displayed three visible prompts: two with suspicion of malignancy scores of 35% (left mediolateral oblique [L MLO] and craniocaudal [L CC]) and one with a suspicion of malignancy score of 10% (right craniocaudal [R CC]), shown as polygonal overlays. Without AI, six of 10 readers (60%) marked a false-positive ROI. With AI assistance, this fell to two of 10 (20%). R MLO = right mediolateral oblique.](https://img.auntminnie.com/mindful/smg/workspaces/default/uploads/2026/07/2026-07-14-radiology-mammogram-ai-auto-bias.H0bYO8QlWs.jpg?auto=format%2Ccompress&dpr=2&fit=crop&h=167&q=70&w=250)
