FDA grants 510(k) clearance for Signostics’ SignosRT Bladder

15 January 2015 (Last Updated January 15th, 2015 18:30)

The US Food and Drug Administration (FDA) has granted 510(k) clearance for Australian medical device firm Signostics new handheld bladder scanner, SignosRT Bladder.

Signor

The US Food and Drug Administration (FDA) has granted 510(k) clearance for Australian medical device firm Signostics new handheld bladder scanner, SignosRT Bladder.

The portable device was designed to use ultrasound technology to automatically and non-invasively calculate bladder volume.

The company said the handheld bladder scanner will reduce health care costs in hospitals and home-care support services.

Signostics business development vice-president Steve Wilson said: "Catheterisation 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 catheterisation can reduce urinary tract infections by up to 50%, which is significant for both health providers and patients.

"The portable device was designed to use ultrasound technology to automatically and non-invasively calculate bladder volume."

"SignosRT Bladder addresses the growing need for mobile medical devices that enabled better diagnosis and care at the bedside."

The device is available in Australia and New Zealand, with applications across different medical sectors, including aged care, home nursing, midwifery, urology and palliative care.

The company intends to launch the new handheld bladder scanner in Europe in March 2015.

Mr Wilson said: "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.

"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."


Image: SignosRT bladder scanner. Photo: courtesy of Business Wire.