Signostics Gets FDA Nod for Portable Ultrasound Bladder Scanner

Signostics has received FDA 510(k) clearance for its hand-held SignosRT Bladder, a portable scanner that automatically and noninvasively calculates bladder volume. The Australian company said the device has the potential to reduce urinary tract infections and healthcare costs.

The SignosRT Bladder utilizes ultrasound technology to gauge bladder volume. The affordable device weighs less than one pound, making it practical and easy for practitioners to carry around, Signostics said.

Catheterization of patients with suspected urinary retention is a major cause of UTIs, and research shows that measuring bladder volume beforehand can reduce infections by up to 50 percent, said Steve Wilson, the company’s vice president. This can help save money and get patients home sooner, he added.

The product is already available in Australia and New Zealand, and is used in the aged care, home nursing, midwifery, urology and palliative care sectors, the devicemaker said. It will launch in Europe in March. — Kellen Owings