Nova Eye’s iTrackTM Advance Canaloplasty Device Won’t be Cleared by Dec. 31

Nova Eye announced that it received feedback from the FDA that the agency will not clear its iTrackTM Advance glaucoma treatment device by year’s end as expected. 

The device, if cleared, would expand the company’s options for canaloplasty, a minimally-invasive surgery which reduces intraocular pressure to treat glaucoma. 

“The regulatory pathway for marketing clearance for canaloplasty in the USA is extremely rigorous and complex,” said Nova Eye CEO Tom Spurling.