US FDA grants 510(k) clearance for Signostics’ ultrasound visualisation device for urology

9 May 2016 (Last Updated November 22nd, 2018 11:26)

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

Uscan

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

Claimed to be the first of its kind, the technology uses algorithms from the science of computer vision to actively recognise the 3D contours of the bladder for an accurate volume measurement even on obese and other hard-to-scan patients.

The device can scan up to 256 bladder slices which is said to be 32 times more than the traditional bladder scanners while still ensuring accuracy.

It also generates real-time ultrasound imaging of the kidneys, pelvic floor, prostate, gallbladder, bladder stones, and catheter emplacement, for quick and easy visual tracking and observation.

Signostics CEO Kevin Goodwin said: "Uscan doesn't just scan; it sees, providing intelligent urologic visualisation 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 specialised ultrasound equipment or sonographers."

Uscan features an integrated middleware which can be used in a range of clinical settings including the emergency department, maternity, pediatrics, oncology, rehabilitation, aged care and home nursing.

"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 specialised ultrasound equipment or sonographers"

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

It can work on Android operating systems and has built-in WiFi and Bluetooth connectivity that enables fast and reliable image management and interoperability with electronic health record (EHR) systems.

Uscan will be marketed in the US this year at a lower cost with a five year product warranty and a no fine print pledge with no annual calibration.

It is simple to use and provides real-time user guidance, requiring no extensive training.


Image: The Uscan ultrasound device. Photo: courtesy of Business Wire.