Optovue’s iCam Receives FDA Clearance

FREMONT, Calif.— Optovue (SD-OCT) has received 510(k) clearance from the Food and Drug Administration for its latest product, the iCam Non-Mydriatic, compact fundus camera. The iCam camera produces 45-degree color fundus images of the eye as well as external ocular structures.

iCam is expected to release to the U.S. market in early Q2, followed by a global release, according to Optovue.