GE Healthcare’s handheld ultrasound device, the Vscan, hit the market in the U.S., Europe, India and Canada today.
The device, which is roughly the size of a smart phone, won 510(k) clearance from the Food & Drug Administration, CE Mark approval in the European Union and a Medical Device License from Health Canada. GE ran a study of the device’s use in real-world setting before a wider release.
Vscan consists of a small, handheld device very similar to a flip-phone, connected to an ultrasound wand. GE Healthcare claims the device "offers the image quality that until recently was only available with a console ultrasound," according to a press release. Its battery is good for one hour, or about 30 two-minute patient scans. It links to a computer via a USB port so its data can be downloaded. The company said it’s designed for abdominal, cardiac, urological, fetal/OB, pediatric, thoracic/pleural, primary and special care applications.