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Topcon Healthcare Receives FDA 510(K) Clearance for Robotic Oct Angiography on the MAESTRO2 Oct Colour Fundus Camera System

Topcon Healthcare 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 colour fundus camera system with OCTA available in the U.S.

“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.

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

It is the reason Topcon has achieved the #1 market position globally for OCT devices. Maestro with OCTA will provide deeper insights and increase clinician confidence while continuing the workflow advantage provided by Maestro’s robotic capture technology.”

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 Registratioallows the clinician to compare subclinical OCT and OCTA findings with corresponding areas on the true colour fundus photograph
  • OCTA Eye Trackingimproves image quality and reduces motion artifact
  • Enface OCTA imaging and Angio Bcolour-coding facilitate a better understanding of normal and abnormal retinal and choroidal vasculature

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

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