Royal Philips Gets FDA Green Light for Mobile Ultrasound System

Dutch healthcare and electronics giant Royal Philips said Thursday it received FDA 510(k) clearance for the VISIQ ultra mobile ultrasound system, enabling scans of obstetrics patients to be performed at any time in a wide range of clinical environments.

The miniaturized tablet-plus-transducer system offers greater mobility, performance and simplicity, and lays the foundation for future portable ultrasound products, the company says.

Clinicians can easily capture high-quality images, take measurements and share data with the system’s built in Wi-Fi, Royal Philips notes. The VISIQ starts up quickly, has long battery life, and the smart transducer fits comfortably in a user’s hand, the company adds.

“VISIQ allows physicians to perform on-the-spot diagnostic scans, limiting the need for patients to go to multiple locations or schedule return visits,” said Gene Saragnese, CEO of imaging systems at Philips Healthcare said.

The device is already commercially available in China, East Africa, France, Germany and India. — Kellen Owings

Subscribe to Devices & Diagnostics Letter for complete coverage of the medical devices industry. Click here for more information.