Clarius gets FDA 510(k) approval for Clarius Bladder AI solution
10 Jan 2024
Clarius Bladder AI is a versatile and cost-effective alternative to dedicated bladder scanners, enabling clinicians the flexibility to also perform ultrasound-guided peripheral IV insertions and general ultrasound exams with a single device
Clarius Bladder AI automatically measures bladder volume. (Credit: Clarius)
Canada-based wireless ultrasound solutions provider Clarius Mobile Health has received the US Food and Drug Administration (FDA) 510(k) approval for Clarius Bladder AI.
Clarius Bladder AI, the latest addition to Clarius AI portfolio, is a non-invasive solution that automatically measures bladder volume and provides real-time feedback to clinicians.
It is also useful for monitoring urinary retention and measuring bladder emptying in patients with neurogenic bladder or urinary tract obstruction, said the company.
The AI solution also comes with other advanced software features that are available with the Advanced Primary/Critical Care Package, included with Clarius Membership.
Clarius is currently offering its new AI tool in the US for use with Clarius PAL HD3, Clarius PA HD3 and the Clarius C3 HD3 wireless handheld ultrasound scanners.
Clarius Bladder AI enables clinicians to perform ultrasound-guided peripheral IV insertions and general ultrasound exams with a single device, said the medical device maker.
Clarius chief technology officer Kris Dickie said: “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.
“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.”
Clarius Bladder AI can be used in acute care to measure postvoid residual urine and evaluate for bladder and urethral stones, hydronephrosis, and upper urinary tract disease.
It can be used in urology clinics for bladder ultrasound, which enhances diagnostic accuracy by assessing bladder volume and contributing to an accurate initial diagnosis during the first visit.
Clarius Bladder AI also has applications in nursing homes, where more than 70% of nursing home residents in the US experience urinary incontinence (UI), said the medical devices maker.
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