Clarius Wireless Ultrasound Receives FDA 510(k) Clearance

App-based ultrasound for medical professionals available now in the US

News provided by

Dec 14, 2016, 10:00 ET

VANCOUVER, British Columbia, Dec. 14, 2016 /PRNewswire/ -- Clarius Mobile Health, a digital healthcare company using technology to reimagine mobile medicine, today announced the U.S. Food and Drug Administration (FDA) has cleared the C3 and L7 Clarius Wireless Ultrasound Scanners. Compatible with the latest iOS and Android smartphones and tablets, Clarius Scanners are available now for medical professionals at clarius.me/shop.

Dr. Geoff Sanz of the University of British Columbia explains why Clarius is his new stethoscope

Clarius scanners and batteries have an IPX7 rating, meaning they are fully submersible in liquid

Clarius ultrasound scanners are ultra-portable, enabling ultrasound anywhere

"Clarius is the future of patient care. The image quality is amazing for any scanner, much less one that fits in my pocket," said Dr. Steven Steinhubl, Director of Digital Medicine at the Scripps Translational Science Institute. "The ability to wirelessly connect it to any Apple or Android device means that anyone on my team can use it with whatever they already carry around in their pocket."

Introduced in March 2016, Clarius Ultrasound Scanners are intended for clinicians to conduct quick scans and to guide short procedures at the bedside. The Clarius C3 multipurpose ultrasound scanner is designed to image the abdomen and lungs; it also incorporates a virtual phased array for quick scans of the heart. The Clarius L7 is ideal for guiding procedures and imaging superficial structures.

"Receiving 510(k) Clearance for our Clarius Scanners is a significant milestone for our company," said Laurent Pelissier, Chairman and CEO of Clarius Mobile Health. "There appears to be a growing trend of digital healthcare companies receiving FDA clearance for innovations designed to deliver more efficient patient care. We are delighted to bring a new class of affordable and easy to use ultrasound to the medical community in the United States."

Unlike other app-based ultrasound systems that draw power from a connected smart device, Clarius Scanners are powered by a rechargeable battery, which is easily exchanged when running low. Two batteries and a charger are delivered with each Scanner. Built with a magnesium case, Clarius Scanners are designed to withstand challenging environments and are water submersible for easy cleaning and disinfection.

"Having used Clarius in an educational setting, I am excited about its potential to put ultrasound into the hands of more clinicians," said Dr. Thomas Cook of 3rd Rock Ultrasound. "Besides being portable and easy to use, I'm very impressed by the image quality produced by such a compact ultrasound machine."

As a direct-to-professionals e-commerce company, Clarius aims to make ultrasound systems affordable and easily accessible to medical professionals. To facilitate online sales, the company offers customers the ability to return the product after a one-week trial period for a small handling fee. The company's e-commerce portal is supported by a telesales team. Clarius Scanners are also available from a network of sales partners across the country.

Clarius Video featuring Geoff Sanz, MD: https://www.youtube.com/watch?v=F5IfIlMnb24

ABOUT CLARIUS
Founded by ultrasound innovators, Clarius Mobile Health is dedicated to making ultrasound available to all clinicians. Our affordable handheld ultrasound scanners improve clinical outcomes and provide the practitioner freedom to use ultrasound anywhere they need it. Clarius Mobile Health Ultrasound Devices are FDA-cleared and the Company is ISO certified. For more information, visit www.clarius.me.

Media Contact
Neena Rahemtulla, VP Marketing, Clarius Mobile Health
Email: [email protected] Tel: 1-604-260-7077

SOURCE Clarius Mobile Health