The Cellularis Discovery by Early Sight

The Cellularis Discovery by Early Sight is a pioneering commercial clinical adaptive optics retinal camera selected to support the FDA’s Ophthalmic Devices Program in advancing the development of novel cellular imaging biomarkers. This device enables high-resolution imaging of retinal cells, providing critical data to accelerate the translation of innovative ophthalmic technologies from research to clinical application. The system will serve as a foundational tool for creating new analytical methods and diagnostic tools aimed at improving early detection and monitoring of retinal diseases. The Food and Drug Administration has issued this forecast to signal intent to procure the Cellularis Discovery system under NAICS code 334516, aligning with its mission to foster medical device innovation and clinical translation. While the solicitation number and set-aside details are not yet available, the contract will be managed by the FDA’s CDRH Acquisition Liaison, with contact information publicly listed as cdrhacquisitions@fda.hhs.gov. The contracting officer role remains to be determined, and the device will be deployed at an unspecified location to support FDA’s research and regulatory activities in ophthalmology.