Ultrasound on your iPhone: FDA approval for mobile-integrated scanner

The integration of mobile and medical devices continues with the FDA awarding 510(k) clearance to Clarius Mobile Health’s C3 and L7 Wireless Ultrasound Scanners.

The handheld, battery-powered scanners are compatible with iOS and Android devices and are intended for quick bedside procedures, such as guiding nerve blocks or targeted injections. The scanner connects to tablets or smartphones via a secure Wi-Fi connection and transfers the images to be viewed, manipulated, or saved.

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

One major advantage of the Clarius devices is cost; care providers could purchase several of the C3 or L7 systems for the price of a single traditional compact ultrasound machine.

The FDA approval of these mobile ultrasound scanners is consistent with the growth of the mobile imaging market, dating back to the 2011 approval of the first mobile diagnostic radiology app. While unfit for primary diagnostic reading, they can serve as cost-effective extensions of workstations, according to a Pharmacy and Therepeutics study.

Integration of mobile devices at every stage of care brings efficiency improvements, including increased convenience of evidenced-based medicine at the point of care and improved accuracy of patient documentation, said the same study.

While hardware costs for tablets and smartphones can be substantial, mobile ultrasound is far from their only application within a practice. Clinicians can utilize clinical decision support apps or diagnostic apps displaying DICOM data, and educators can use interactive e-books and encyclopedias.  The wide variety of uses bolsters the value proposition and softens the blow of a several-hundred-dollar device.

"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."