Adaptive Optics (AO) Retinal Imaging System

The FDA's Center for Devices and Radiological Health (CDRH) intends to solicit a complete Adaptive Optics (AO) Retinal Imaging System, with a sources sought notice response deadline of May 12, 2026, at 4:00 PM Eastern Time.

The system will be deployed at the FDA White Oak Campus in Silver Spring, Maryland, in the Optical Diagnostic Devices Laboratory to support ophthalmic research programs, including adaptive optics biomarker development, regulatory science tools advancement, and retinal phantom development for testing standards. The FDA seeks a single contractor to provide hardware, software, delivery, installation, and operator training. Collaborative research will involve the National Eye Institute, University of Maryland Baltimore, and Johns Hopkins University Wilmer Eye Institute.

Hardware must incorporate pupillary reflectance imaging and non-contact transscleral flood illumination using infrared LED and SLD light sources (750–890 nm), with lateral optical resolution of 2–3 micrometers, 1-micrometer pixel pitch, 300-micrometer focusing range, cellular view field angle greater than 6.5 × 6.5 degrees, 30 × 30-degree fundus overview field angle, minimum 4 mm pupil diameter, and refractive error adjustment from +15 D to –15 D. Acquisition time must be under 3 seconds. Software must enable simultaneous live widefield and cellular-level imaging, pupil alignment feedback, and follow-up image comparison. The system operates on 100–240 V, 50–60 Hz input with maximum power consumption of 450 W.

This is market research only and will not result in contract awards. NAICS 334510 (Electromedical and Electrotherapeutic Apparatus Manufacturing) applies, with a small business size standard of 1,250 employees. Contact Contract Specialist Freshta Javid at freshta.javid@fda.hhs.gov.