OptoVue Obtains 510(k) Clearance for RTVue OCT’s Normative Database

OptoVue, an ophthalmic instrument company, has obtained 510(k) clearance for the RTVue OCT unit’s Normative Database (NDB). The company rolled out a fourier/spectral domain OCT in the United States.

The spectral domain was first cleared by the Food and Drug Administration (FDA) for retinal and corneal imaging applications. The NDB for the RTVue device includes more than 600 eyes. It is the largest NDB to be cleared by FDA for an OCT instrument.

OptoVue’s Senior Director of Clinical Research, Mike Sinai stated that the clearance confirms the management and protocols of the company, which has reached the level required by the FDA. The clearance shows the efficiency and safety of the NDB based on the current standard of FDA.

Sinai added that the NDB is the only database that takes into account the signal strength of the scan and the age of the patient. These factors provide clinicians a high level of confidence in the NDB, which is used as a reference tool for assessing the retina nerve fiber thickness.