Mobile ultrasound developer Clarius Mobile Health said today it won FDA 510(k) clearance for its C3 and L7 Clarius wireless ultrasound scanners.
Clarius’ C3 multipurpose ultrasound scanner is designed to image the abdomen and lungs, with an incorporated virtual phased array for heart scans, while the L7 is designed for guiding procedures and imaging superficial structures.
“Clarius is the future of patient care. The image quality is amazing for any scanner, much less one that fits in my pocket. 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,” Dr. Steven Steinhubl of the Scripps Translational Science Institute said in a press release.
Clairus’ ultrasound scanners are wireless and operate with a mobile app on a smart device, and is designed to be highly portable for quick exams and to guide procedures such as nerve blocks and targeted injections, the New York-based company said.
“Receiving 510(k) clearance for our Clarius Scanners is a significant milestone for our company. 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,” chair & CEO Laurent Pelissier said in prepared remarks.
“Having used Clarius in an educational setting, I am excited about its potential to put ultrasound into the hands of more clinicians. Besides being portable and easy to use, I’m very impressed by the image quality produced by such a compact ultrasound machine,” Dr. Thomas Cook of 3rd Rock Ultrasound said in a prepared statement.