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FDA approves OD-OS navigated laser photocoagulation system
DALLAS — OD-OS, a subsidiary of SensoMotoric Instruments, received U.S. Food and Drug Administration approval for its Navilas laser for image-guided treatment of retinal disorders, the company announced.
The company was granted 510(k) clearance to market the patented device, according to a press release.
Navilas enables real-time imaging of the retina during laser photocoagulation for disorders such as diabetic retinopathy and diabetic macular edema, the release said. It provides a 50° field of view that can be panned, as well as live imaging of the fundus in true color, infrared, red-free and fluorescein angiography.
Additionally, Navilas enables surgeons to minimize neck and back strain associated with slit lamp examination, the release said.
Navilas was demonstrated at the Retina Congress in September and the American Academy of Ophthalmology meeting last month, where it was announced that post-treatment color overlay photographs indicated a microaneurysm hit rate of 92% for Navilas.