Clarius Mobile Health gets FDA clearance for app-based, wireless ultrasound scanners

By Heather Mack
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Vancouver, BC-based Clarius Mobile Health has received FDA 510 (k) clearance for its app-based, wireless, handheld ultrasound scanners.

The devices, which are designed for clinicians to quickly conduct scans and guide short procedures at the bedside, are compatible with the latest smartphones and tables both for iOS and Android and are now available for medical professionals on Clarius’s website. The Clarius C3 is made for performing ultrasound scans of the abdomen and lungs and also features a virtual phased array for quick scans of the heart. The other device is the Clarius L7, a procedural guidance and superficial imaging scanner. Users can also save, share manage the ultrasound images for both devices privately on the Clarius Cloud.

Clarius Mobile Health was founded in 2014 by experts across research and development, manufacturing, operations and sales of ultrasound technology. The team includes developers who worked on the first PC-based platform for ultrasound research and first touch screen ultrasound system, and the company is working on numerous mobile devices.

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

Clarius’s devices are designed for high-use and convenience, and they don’t require a separate connected smart device to work. Both devices are water-submersible, battery-powered and built with a magnesium case to withstand what the company refers to as “challenging” environments (also known as clinical settings). Both the C3 and L7 come in a basic or premium version, which are $6,900 and $9,900, respectively. 

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