Topcon Healthcare has received US Food and Drug Administration (FDA) 510(k) clearance for its optical coherence tomography angiography (OCTA) technology on the robotic Maestro2 OCT color fundus camera system, making it the first and only robotic OCTA device available in the United States.
The upgraded Maestro2 system offers 3×3, 4.5×4.5, and 6x6 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 or artery occlusions, the company said in a press release. The device’s PinPoint Registration feature allows precise comparison of OCT findings with color fundus photos as well as eye-tracking technology to reduce image artifacts.
Topcon says that most customers who already own the Maestro2 will be able to upgrade to the technology.