FDA clears OCTA on robotic Maestro2 color fundus camera system
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The FDA granted 510(k) clearance for OCT angiography on the robotic Maestro2 OCT color fundus camera system, according to a press release from Topcon Healthcare.
Maestro2 is designed to provide “flexibility to leverage high-resolution images in the macula” when assessing age-related macular degeneration through 3 mm × 3 mm, 4.5 mm × 4.5 mm and 6 mm × 6 mm OCT angiography (OCTA) scans, according to the release. These scan settings also allow for wider areas of investigation for diabetic retinopathy and vein or artery occlusions.
Other features allow for comparison between subclinical OCT and OCTA findings with corresponding areas on true color fundus photographs, eye tracking for improved image quality, and en face OCTA imaging and Angio-B color coding to distinguish normal and abnormal retinal and choroidal vasculature.
Maestro2 is the only robotic OCT color fundus camera system with OCTA in the U.S., according to the release.
“Maestro with OCTA will provide deeper insights and increase clinician confidence while continuing the workflow advantage provided by Maestro’s robotic capture technology,” M. Lance Patton, chief commercial officer of Topcon Healthcare, said in the release.
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