Gyroscope Therapeutics has received 510(k) clearance from the FDA for the Orbit subretinal delivery system, according to a press release.
The system is indicated for subretinal microinjection of balanced salt solution or BSS Plus at the back of the eye. The procedure would help prevent the need for vitrectomy and eliminate the need for retinotomy creation to access the subretinal space.
“The Orbit SDS is exquisitely designed to target the subretinal space, with the aim of providing precise and consistent dosing,” Khurem Farooq, CEO of Gyroscope Therapeutics, said in the (Read more...)
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