EYECARE Topcon Healthcare Receives FDA 510(k) Clearance for OCTA on Robotic OCT Color Fundus Camera System By Staff Friday, September 13, 2024 12:21 AM OAKLAND, N.J.—Topcon Healthcare, Inc., a provider of robotic medical devices and digital health care solutions, has 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 what the company claims is the first and only robotic OCT color fundus camera system with OCTA available in the U.S. The Maestro2 offers 3×3mm, 4.5×4.5mm and 6x6mm OCTA scans, according to the company, 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. "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 number one 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.” Doctors can purchase OCTA upgrades for most existing Maestro2 devices, according to the company. For more information on the Maestro2 with OCTA, click here.