FDA Seeks ‘Phantom’ Retina With An Eye Toward OCT Device Bench Testing

After receiving a grant last year, CDRH researchers are working toward a consensus phantom eye model to allow for standardized bench testing for optical coherence tomography device submissions.

Optical coherence tomography imaging is playing a growing role in ophthalmology diagnosis, but it is lacking something that other established imaging modalities have: a consensus “phantom” eye model to bench test image quality, say FDA researchers.

The agency wants to collaborate with others to address that issue. Funding awarded last year from FDA’s Critical Path Initiative...

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