Published in Products

Topcon Healthcare receives FDA 510(k) clearance for robotic OCTA on the Maestro2 OCT color fundus camera system

Topcon Healthcare, Inc. announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for OCTA on the robotic Maestro2, making it the first and only robotic OCT color fundus camera system with OCTA available in the U.S.

Maestro2 – The Robotic OCT Fundus Camera from Topcon, now with OCTA

“The integration of OCTA into Maestro2 adds additional clinical horsepower to an already outstanding instrument without sacrificing ease of use,” said M. Lance Patton, chief commercial officer for Topcon Healthcare.

“With its single-touch image acquisition, Maestro has been an enormous success. It is the reason Topcon has achieved the #1 market position globally for OCT devices.1 Maestro with OCTA will provide deeper insights and increase clinician confidence while continuing the workflow advantage provided by Maestro’s robotic capture technology.”

The integration of OCTA into Maestro2 adds additional clinical horsepower to an already outstanding instrument without sacrificing ease of use.

The Maestro2 offers 3×3, 4.5×4.5, and 6x6mm OCTA scans, which provide the flexibility to leverage high-resolution images in the macula when assessing AMD, as well as examination of wider areas needed for diabetic retinopathy and vein/artery occlusions.

Additional features include:

  • PinPoint Registration™ allows the clinician to compare subclinical OCT and OCTA findings with corresponding areas on the true color fundus photograph
  • OCTA Eye Tracking improves image quality and reduces motion artifact
  • Enface OCTA imaging and Angio B color-coding facilitate a better understanding of of normal and abnormal retinal and choroidal vasculature

Due to the valuable clinical information it provides and the automated capture, we anticipate that most new Maestro purchases will include the OCTA option. Doctors can also purchase OCTA upgrades for most existing Maestro2 devices.

For more information on the Maestro2 with OCTA, contact your local Topcon Healthcare representative or visit topconhealthcare.com/maestro2.


Reference
  1. Ophthalmic Diagnostic Equipment Report: Global Analysis for 2023 to 2029, Market Scope, July 2024.