Topcon Receives FDA Clearance for OCT Angiography on the Maestro2 System

Topcon Healthcare has received FDA 510(k) clearance for OCT angiography (OCTA) on the company’s Maestro2 robotic OCT color fundus camera system.

Topcon, state the Maestro2 offers 3×3-mm, 4.5×4.5-mm, and 6×6-mm OCTA scans, which provide the flexibility to leverage high-resolution images in the macula when assessing age-related macular degeneration, as well as examination of wider areas needed for diabetic retinopathy and vein/artery occlusions.

The system also features the company’s PinPoint Registration, which allows the clinician to compare subclinical OCT and OCTA findings with corresponding areas on the true color fundus photograph; OCTA eye tracking, which improves image quality and reduces motion artifact; and Enface OCTA imaging and Angio B color-coding, which facilitate a better understanding of normal and abnormal retinal and choroidal vasculature.

The company anticipates that most new Maestro purchases will include the OCTA option because of the valuable clinical information it provides and the automated capture. Also, OCTA upgrades can be purchased for most existing Maestro2 devices, stated Topcon.