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FDA grants 510(k) clearance to Topcon's robotic Maestro2 for OCTA

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4 min read

Topcon Healthcare, Inc. has received 510(k) clearance from the FDA for optical coherence tomography angiography (OCTA) on the robotic Maestro2 fundus camera system—making it the only robotic OCTA device currently available in the United States.

We’ll start with the basics: Tell me about the Maestra2.

Maestro2 is a robotic OCT fundus camera system designed to assess both retinal structure and vascular function in “unparalleled detail,” as the device is marketed, in one single scan.

Plus: Its OCT reference data capabilities extend to the following:

  • Optic nerve
  • Retinal nerve fiber layer (RNFL)
  • Ganglion cell
  • Macular thickness

I need a visual of this.

See a demo of the camera.

(And access Topcon’s training videos for how to operate it.)

Now talk features.

Notable key components of the Maestro2 include:

  • Robotic OCT and fundus camera (for user-friendly accessibility)
  • Full 360° rotating touchscreen
  • OCTA-enabled aerial views of the retinal vasculature at “predefined levels relevant to disease”
  • Color-coding for identifying normal and abnormal blood flow
  • 12x9 mm 3D wide scan for capturing the macula and optic disc
  • True color fundus photography in high-definition (simultaneously captured with white light, 24-bit color)

Zero in on this OCTA.

The new OCTA feature of the Maestro2 is intended to provide clinicians with deeper insights and increased confidence, according to Topcon CCO M. Lane Patton.

As for scan width, with OCTA, the fundus camera now offers the following:

  • 3x3 mm
  • 4.5x4.5 mm
  • 6x6 mm

What this enables: Ideally, these width ranges give clinicians the flexibility to use high-resolution images in the macula when examining AMD—plus the ability to examine wider areas in instances of diabetic retinopathy (DR) and vein/artery occlusions.

What other new components are included?

With this OCTA addition, the fundus camera also provides:

  • PinPoint Registration
    • Allows clinicians to compare subclinical OCT and OCTA findings with corresponding areas on a true-color fundus photograph
  • OCTA Eye Tracking
    • Results in reduced motion artifact and improved image quality
  • Enface OCA imaging and Angio B
    • Color-coding enables better distinction between normal and abnormal blood flow

Nice! Can the Maestr02 still connect to a reference database?

Indeed it can. Specifically, the device can integrate with Topcon’s clinical image and data management system: Harmony.

About Harmony: This solution is designed to streamline clinical practice workflow and organize all ophthalmic clinical data with just one screen.

The resulting capabilities:

  • Minimization of transcription errors
  • Reduced need for instrument-specific software
  • Customizable reporting
  • Vendor-neutral connecting (enabling all devices, regardless of type or brand)
  • Secure browser-based access
  • Telehealth portal for second opinion consulting/referrals

So what if I already have the Maestro2 (sans OCTA)?

The company noted that clinicians who already own the device can purchase the OCTA option for most existing Maestro2 devices.

And for any new purchases: The fundus camera will automatically include the OCTA option.

That’s a relief. So how can I purchase this?

Get in touch with your local Topcon representative by contacting the company.

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