FDA Clears Gyroscope Therapeutics’ Subretinal Delivery System

Gyroscope Therapeutics has received 510(k) clearance from the FDA for its Orbit syringe that enables surgeons to access the subretinal space at the back of the eye.

The device is indicated for microinjection into the subretinal space and is designed to avoid damaging the eye by eliminating the need for removal of the eye’s vitreous gel.

The syringe, which delivers a controlled amount of salt solution to a targeted site, also eliminates the need to create a hole in the retina to access the subretinal space.