Signostics Gets FDA 510k Clearance for Handheld Bladder Scanner

ADELAIDE, Australia

Medical device company, Signostics, announced today it has clearance from the U.S. Food and Drug Administration to launch the SignosRT Bladder, the company’s new hand-held bladder scanner.

SignosRT Bladder scanner (Photo: Business Wire)

The 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.

The product 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.

Steve Wilson, Vice President of Business Development, said the SignosRT Bladder could help save money and get patients home sooner.

“Catheterization of patients with suspected urinary retention is a significant cause of urinary tract infections increasing the length of hospital stays,” he said. ¹

“Research shows using ultrasound to accurately measure bladder volume before catheterization can reduce urinary tract infections by up to 50 per cent², which is significant for both health providers and patients.”

Mr Wilson said the SignosRT Bladder addressed the growing need for mobile medical devices that enabled better diagnosis and care at the bedside.

“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.

“With a rapidly aging population in most Western countries, home health care is expanding and portability and affordability are key elements for adoption in this segment.

“The SignosRT bladder scanner weighs less than one pound and fits into the palm of your hand so it’s an easy tool for doctors and nurses to carry anywhere.”

¹ Graves N, Tong E, Morton AP, Halton K, Curtis M, Lairson D, Whitby M, “Factors associated with health care-acquired urinary tract infection”, American Journal of Infection Control, Volume 35, Issue 6, Pages 387-392 (August 2007)
² Moore DA, Edwards K. Using a portable bladder scan to reduce the incidence of nosocomial urinary tract infections. MEDSURG Nursing 1997; 6:39–43.

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