Signostics Receives FDA Clearance for Uscan™ – The World’s First Smart Mobile-Connected Visualization Device Specialized for Urologic Care

KIRKLAND, Wash.–(BUSINESS WIRE)–Signostics, the global innovator in smart, high reliability ultrasound
devices for urology, announced today that it has received U.S. Food and
Drug Administration (FDA) 510(k) clearance for Uscan™, the first smart
mobile-connected ultrasound visualization device targeted at urologic
care.
Using algorithms from the science of computer vision, Uscan actively
recognizes the 3D contours of the bladder, for far more accurate volume
measurements than the industry standard* even on obese and other
hard-to-scan patients. It acquires up to 256 bladder slices – 32 times
more than conventional bladder scanners – resulting in industry-leading
accuracy. It also provides real-time ultrasound imaging of the kidneys,
pelvic floor, prostate, gallbladder, bladder stones, and catheter
emplacement, for quick and easy visual tracking and observation.
“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,” said Kevin Goodwin, CEO. “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.”
Uscan also offers integrated middleware not found in any comparably
priced systems; and can be used in a range of clinical settings beyond
urology, including the emergency department, maternity, pediatrics,
oncology, rehabilitation, aged care and home nursing. The system’s
removable probe, high-resolution touch screen tablet and handheld
displays make it ideally suited for on-the-go clinical care.
It is compatible with 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 also offers the industry’s lowest cost of ownership in this market
space, coming with a designed- in 5-year product warranty, with a “no
fine print” pledge and requires no annual calibration. It is simple to
learn and use, and provides real-time user guidance, eliminating the
need for extensive training.
Signostics will introduce Uscan to U.S. healthcare providers attending
the American Urological Association’s 2016 Annual Meeting (AUA 2016) May
6-10, 2016 in San Diego, California.
Uscan is anticipated to be commercially available in the U.S. by June
2016.
About Signostics
Signostics Inc. is a wholly-owned subsidiary of Signostics Limited, a
global medical device manufacturer. A KKR portfolio company, Signostics
is pioneering smart ultrasound devices to enhance imaging and clinical
decision making in urologic care. The company’s products include Uscan,
SignosRT ultrasound systems and the SignosRT Bladder Scanner –
ultra-portable, affordable devices designed to assist with the diagnosis
of common medical presentations at the bedside. The company has
regulatory approvals in the U.S., Australia, Canada, Europe, Singapore
and Japan, and exports to countries around the world. For more
information, visit www.signosticsmedical.com.
Signostics and Uscan are Trademarks of Signostics Limited.
Caution: Federal (USA) law restricts this device to sale by or on the
order of a physician.
*Based on comparative measurements of a phantom of known volume.