FDA gives 510(k) approval to SignosRT Bladder Ultrasound Imaging System-Signostics
Signostics has announced it has clearance from the FDA to launch the SignosRT Bladder, the company�s new hand-held Ultrasound Imaging bladder scanner. The device 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 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.
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.
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