FDA grants 510(k) clearance to AI-powered bladder volume measurement for handheld ultrasound

The FDA has granted 510(k) clearance to the Clarius Bladder AI ultrasound software, which may have significant utility in acute care settings, urology clinics, and nursing homes.¹

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

Clarius Mobile Health, the manufacturer of Clarius Bladder AI, explained in a press release that the software provides automated bladder volume measurements in seconds.¹

(Editor’s note: This article has been adapted from its original publication on our sister site Diagnostic Imaging.)

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,” Oron Frenkel, MD, an emergency physician who practices in the United States and Canada, stated in the news release.¹ "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% of nursing home residents.¹

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

Ultrasound study

As support for use of Clarius Bladder AI ultrasound software, Clarius cited a 2023 study, “Assessing the impact of bladder ultrasound on catheter-associated urinary tract infections and health-care costs: an observational pre-post study.”²

Describing their reason for launching the study, the authors wrote, “To assess the appropriateness of urinary catheter placement using bladder ultrasound [and] to monitor urinary catheter-associated urinary tract infections and costs associated with catheter use.”

Researchers conducted the single-center pre-post observational study between September 2021 and August 2022. The study population comprised patients aged >18 years who required urinary monitoring. The first 6 months of research made up the control group of patients evaluated without the use of bladder ultrasound. Patients in the last 6 months made up the experimental group of patients assessed with the use of bladder ultrasound.

There were 189 patients and 175 patients in the pre- and post-ultrasound groups, respectively. Patient demographics and clinical characteristics were well balanced between the 2 groups.

The results showed that in the post-group there was no inappropriate catheterization performed, whereas in the pre-group there was a 22.6% rate of inappropriate catheterization. Additionally, the rate of urinary tract infections was 8.5% vs 6.3% in the pre- vs post-groups, respectively, representing an absolute reduction of 2.2% in the rate of urinary tract infections. Also of note, the costs associated with urinary catheter use were lowered by 74.2% between the first 6 months and the final 6 months of the study.

“Bladder ultrasound in clinical practice is feasible and reduced the inappropriate use of bladder catheters, reducing patient risks and health care costs,” the authors wrote in their conclusion.²

References

1. Clarius Adds AI-Driven Automatic Bladder Volume Measurements to its Wireless Handheld Ultrasound Scanners Designed for Acute Care, Urology, and Nursing. Published online January 9, 2024. Accessed January 15, 2024. https://www.prnewswire.com/news-releases/clarius-adds-ai-driven-automatic-bladder-volume-measurements-to-its-wireless-handheld-ultrasound-scanners-designed-for-acute-care-urology-and-nursing-302029535.html

2. Di Matteo R, Caccamo I, Arcidiacono S. [Assessing the impact of bladder ultrasound on catheter-associated urinary tract infections and health-care costs: an observational pre-post study]. Assist Inferm Ric. 2023 Jul-Sep;42(3):131-136. doi: 10.1702/4095.40917.