Register Now: Image-Based Risk: The Next Frontier in Breast Cancer Screening
News|Articles|January 10, 2024

FDA Clears AI-Powered Bladder Volume Measurement for Handheld Ultrasound

Author(s)Jeff Hall

Offering enhanced utility for assessing urinary incontinence, bladder emptying and urinary retention, the Clarius Bladder AI ultrasound software reportedly provides bladder volume measurement in seconds.

The Clarius Bladder AI ultrasound software, which may have significant utility in acute care settings, urology clinics and nursing homes, has garnered 510(k) clearance from the Food and Drug Administration (FDA).

Clarius Mobile Health, the manufacturer of Clarius Bladder AI, said the software provides automated bladder volume measurements in seconds.

The artificial intelligence (AI)-powered software is particularly useful for assessing urinary retention and bladder emptying in cases involving obstruction of the urinary tract or patients with a neurogenic bladder, according to the company.

“Bladder AI removes the tedious steps of calculating bladder volume in my patients with urinary retention,” says Oron Frenkel, M.D., an emergency physician who practices in the United States and Canada. "It helps me quickly identify who needs a catheter placed or further investigation for any urinary or abdominal pain symptoms."

Clarius Mobile Health noted that other clinical applications for Clarius Bladder AI include evaluation of upper urinary tract disease in acute care settings and urinary incontinence, which may affect up to 70 percent of nursing home residents.

Clarius Bladder AI is available with the Clarius Mobile Health handheld ultrasound models PAL HD3, PA HD3 and C3 HD3, according to the company.


Related to this article

Key Sessions of Interest for Radiologists at the Upcoming HLTH USA Conference
How will generative AI software be evaluated by the FDA in the future? What’s next for point-of-care ultrasound? What steps have been successful in facilitating adoption of AI applications across enterprise systems? Leaders in radiology and health care will be discussing these topics and more at the upcoming HLTH USA conference.
Current Perspectives on Integrating AI into Radiology
In a recent interview with Diagnostic Imaging, Joseph Cavallo, MD, MBA, offered insights on post-deployment monitoring with AI, the potential for improved workflow efficiency and the ongoing challenge of balancing essential clinical skills and AI literacy in the training of radiology residents and fellows.