FDA Clearance for Handheld Bladder Scanner

Medical device company, Signostics, has gained U.S. FDA (510(k) clearance for its SignosRT Bladder, the company’s new hand-held bladder scanner.


Signostics says its SignosRT Bladder is an affordable, portable device designed to use ultrasound technology to automatically and non-invasively calculate bladder volume and has the potential to assist in reducing health care costs in hospitals and home-care support services.  It taps into the demand for affordable mobile medical devices that enable better diagnosis and care at the bedside.

Weighing under one pound the scanner fits into the palm of the hand so is easily portable.

It is already sold in Australia and New Zealand with applications across a number of medical sectors including aged care, home nursing, midwifery, urology and palliative care. Plans are also underway to launch the device in Europe in March 2015.

Company comments

Steve Wilson, Vice President of Business Development, said; “Catheterization of patients with suspected urinary retention is a significant cause of urinary tract infections increasing the length of hospital stays.

“Research shows using ultrasound to accurately measure bladder volume before catheterization can reduce urinary tract infections by up to 50 per cent, which is significant for both health providers and patients.”

“This is a revolution in health care and has the potential to transform community nursing, geriatrics, in-hospital maternity care, and long-term care.

“We’re already getting a great response from the Royal District Nursing Service in Australia (RDNS SA) who use the scanners in home visits and we see a significant opportunity for the product where urinary tract infections are a problem in hospital or home settings, as well as in long-term care facilities.

Source: Business Wire

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