FDA clears app-based ultrasound from Clarius

Ultrasound technology start-up Clarius Mobile Health has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Clarius C3 and Clarius L7 app-based ultrasound scanners.

The Clarius ultrasound device. Both Clarius C3 and Clarius L7 are designed to connect with iOS and Android smartphones and tablets, the company said. Unlike other app-based ultrasound devices that draw power from the mobile device they are connected to, the Clarius systems have their own rechargeable battery pack, which can be exchanged when it runs low.

Clarius C3 is a multipurpose ultrasound scanner that can image the abdomen and lungs; it also incorporates a virtual phased array for quick scans of the heart. Clarius L7 is designed to help clinicians guide procedures and image superficial structures.