VANCOUVER, BC, Jan. 9, 2024 /PRNewswire/ -- Clarius Mobile Health, a global leader in wireless ultrasound solutions, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new Clarius Bladder AI, a non-invasive tool that automatically measures bladder volume in seconds. It's available now in the United States with the Clarius PAL HD3, Clarius PA HD3 and the Clarius C3 HD3 wireless handheld ultrasound scanners.
"Bladder AI removes the tedious steps of calculating bladder volume in my patients with urinary retention," says Dr. Oron Frenkel, 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."
The latest addition to the Clarius AI portfolio, Clarius Bladder AI accurately measures bladder volume and provides real-time feedback to clinicians. It is particularly useful for monitoring urinary retention and assessing bladder emptying in patients with neurogenic bladder or urinary tract obstruction. Clarius Bladder AI is included among other advanced software features that are available with the Advanced Primary / Critical Care Package, included with Clarius Membership. Current Clarius members with eligible scanners will be able to use the new application on their Clarius scanners today.
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According to a 2023 published study, "bladder ultrasound in clinical practice is feasible and reduced the inappropriate use of catheters, reducing patient risks and healthcare costs."
In contrast to dedicated bladder scanners priced at approximately 15,000 USD, Clarius offers an affordable all-in-one solution that integrates bladder scanning with whole-body HD ultrasound for abdominal, pelvic, and thoracic imaging, and for guiding precise IV access. Healthcare institutions can save on bladder scanning equipment by purchasing Clarius scanners starting at 3,595 USD plus annual membership.
"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."
