Optovue receives FDA clearance of iCam
Optovue has received 510(k) clearance for its iCam non-mydriatic, compact fundus camera.
Fremont, CA-Optovue has received 510(k) clearance for its iCam non-mydriatic, compact fundus camera.
The iCam produces 45-degree color fundus images of the eye as well as external ocular structures. iCam includes a variety of functions and features that produce high-quality image documentation and management of ocular health. A 12-bit CCD image sensor provides deep, rich colors with lower noise than 8-bit CMOS sensors. An LED light source is used for reduced peak light energy to the eye as well as longer life.
The device includes simple joystick control, focusing and positioning aids to expedite the photography process while an easy user interface enables image review and EMR communication.
iCam is expected to release to the U.S. market in Q2, followed by a global release.
