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FDA Clears AI-Powered Bladder Volume Measurement for Handheld Ultrasound

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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.

FDA Clears AI-Powered Bladder Volume Measurement for Handheld Ultrasound

Reportedly capable of providing automated bladder volume measurements in seconds, Clarius Bladder AI 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 Clarius Mobile Health, the manufacturer of the software.

“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.

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