MedOne Surgical announced the FDA 510(k) clearance of its MicroDose Injector device for low volume ophthalmic injections into the subretinal space. The pneumatically driven syringe system allows the surgeon to utilize a pneumatic air source, such as a vitrectomy system, to deliver a low volume injection into the subretinal space. The pneumatic system allows complete surgeon control, superior to manual injections, while reducing waste of the injectate, according to MedOne Surgical. The MicroDose, combined with one of the company’s subretinal cannulas, provides the optimal system for subretinal injections.
“While currently being used for delivery of low volume injections, we are excited about the role the MicroDose Injector may play in the delivery of ground breaking, sight saving treatments being developed around the world such as gene and stem cell therapies,” Bruce Beckstein, President of MedOne, said in a company news release.
The MicroDose Injector is commercially available for use now.