FDA Clears Smart Mobile-Connected Bladder Ultrasound Device

Megan Brooks

Disclosures

May 06, 2016

The US Food and Drug Administration (FDA) has granted 510(k) clearance for Uscan (Signostics), the first smart mobile-connected ultrasound device for use in urologic care, according to a company news release.

Using computer algorithms, Uscan actively recognizes the three-dimensional contours of the bladder, for more accurate volume measurements than the industry standard, even in obese and other hard-to-scan patients, the company notes in a news release.

Uscan acquires up to 256 bladder slices, which is 32 times more than conventional bladder scanners. It also provides real-time ultrasound imaging of the kidneys, pelvic floor, prostate, gallbladder, bladder stones, and catheter placement, they say.

"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," Signostics Chief Executive Officer Kevin Goodwin said in the release.

"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," he predicted.

Beyond urology, the company sees a role for Uscan in a range of clinical settings, including the emergency department, maternity, pediatrics, oncology, rehabilitation, aged care, and home nursing. The system has a removable probe, high-resolution touchscreen tablet, and handheld displays, making it well suited for "on-the-go" clinical care, the company said.

Uscan is compatible with Android operating systems and has built-in WiFi and Bluetooth connectivity that enables fast and reliable image management and integration with electronic health record systems. "It is simple to learn and use, and provides real-time user guidance, eliminating the need for extensive training," the company said.

The company will introduce the Uscan device at the American Urology Association 2016 annual meeting that gets underway today in San Diego, California. They anticipate Uscan to be commercially available in the United States by June 2016.

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