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US FDA Clears Signostics' Uscan Smart Mobile-Connected Urologic Care Visualisation Device.

M2 PHARMA-May 6, 2016-US FDA Clears Signostics' Uscan Smart Mobile-Connected Urologic Care Visualisation Device


- US-based urology ultrasound device company Signostics has received US Food and Drug Administration 510(k) clearance for its Uscan mobile-connected ultrasound visualisation device targeted at urologic care, the company said.

Using algorithms from the science of computer vision, Uscan actively recognizes the 3D contours of the bladder, for far more accurate volume measurements, 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.

The device 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 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 systems.

Uscan is anticipated to be commercially available in the US by June 2016.

Signostics Inc. is a wholly-owned subsidiary of Signostics Ltd., a medical device manufacturer. A KKR portfolio company, Signostics is developing 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 US, Australia, Canada, Europe, Singapore and Japan, and exports to countries around the world.

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Publication:M2 Pharma
Date:May 6, 2016
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