Signostics has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its smart mobile-connected ultrasound visualization device, Uscan, for urologic care.


Uscan actively identifies the 3D contours of the bladder with the help of algorithms from the science of computer vision.

The device provides real-time ultrasound imaging of the kidneys, pelvic floor, prostate, gallbladder, bladder stones, and catheter emplacement.

According to the company, the device captures up to 256 bladder slices, which is 32 times more than conventional bladder scanners.

It can also be used in various clinical settings, including the emergency department, maternity, pediatrics, oncology, rehabilitation, aged care and home nursing.

The system features removable probe and high-resolution touch screen tablet and handheld displays, making it suitable for on-the-go clinical care.

Signostics CEO Kevin Goodwin said: "Uscan doesn’t just scan; it sees – providing intelligent urologic visualization by leveraging science from current-day computer vision algorithms aimed at more efficient and confident point-of-care clinical decision-making.

"Uscan will exceed historical industry standards for bladder volume measurement accuracy yet will also enable use for other urologic imaging needs, reducing the delays and expense of engaging specialized ultrasound equipment or sonographers."

Signostics plans to commercially launch the Uscan device by June.

The company will exhibit Uscan at the US American Urological Association’s 2016 annual meeting in San Diego, California, which is being held from 6 to 10 May.

Image: Signostics’ smart mobile-connected ultrasound visualization device Uscan. Photo: courtesy of Signostics.