Wireless ultrasound equipment provider Clarius Mobile Health announces that it has obtained U.S. FDA 510(k) clearance for the Clarius Bladder AI, which provides non-invasive bladder volume measurements. Clarius Bladder AI is now available in the United States and can be used with Clarius PAL HD3, Clarius PA HD3, and Clarius C3 HD3 wireless handheld ultrasound scanners.

Clarius Bladder AI streamlines the measurement of bladder volume and includes whole-body ultrasound capabilities for abdominal, pelvic, thoracic imaging, and precise IV access guidance. This addition to the Clarius AI portfolio is useful for monitoring urinary retention and evaluating bladder emptying in patients with neurogenic bladder or urinary tract obstruction.

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

Clarius Bladder AI is included in the Advanced Primary/Critical Care Package, available to Clarius members with compatible scanners. A 2023 study highlights the feasibility of bladder ultrasound in clinical practice, potentially reducing the inappropriate use of catheters and associated healthcare costs. 

“We made the decision to develop Clarius Bladder AI in response to the increasing demand from health systems for multi-function devices that can be used by physicians, nurses, and other ancillary staff for ultrasound-guided peripheral IV insertions and bladder scanning,” says Kris Dickie, Clarius’ chief technology officer. “Paired with our new Clarius PAL HD3, which offers the capability to image deep anatomy and superficial anatomy, it’s a more cost-effective and versatile tool than current bladder scanners.”