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AI Optics receives FDA 510(k) clearance for handheld retinal imaging system

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4 min read

The FDA has granted 510(k) clearance to AI Optics Inc. for its Sentinel Camera, a portable retinal imaging system for retinal screenings.

Let’s start with this company.

Headquartered in New York, New York, AI Optics is a private medical device and digital health company developing retinal screening technology via the use of artificial intelligence (AI) and portable hardware.

Its product portfolio thus far:

  • Sentinel Camera (more information on that in a moment)
  • Sentinel Pro (not yet FDA-cleared; currently only intended for investigational use)
    • A next-generation device incorporating AI-based disease screening modules with the Sentinel Camera’s portable imaging technology—combining them into a single device that can be integrated into existing clinical workflows.
      • The target diseases to diagnose: Diabetic retinopathy (DR), age-related macular degeneration (AMD), and glaucoma

The design intent behind both products: “To make early diagnosis reliable, efficient, and user-friendly,” according to AI Optical.

Now talk about the Sentinel Camera.

This handheld retinal camera is small, lightweight, and portable—enabling point-of-care retinal imaging so some patients can skip the visit to a retinal specialist’s clinical practice.

  • To note: The Sentinel also supports non-dilated imaging (in lieu of pupil dilation via eye drops), which can be useful for repeated assessments to monitor ocular changes in response to treatments.

And what features does it include?

The Sentinel is equipped with a usability-targeted user interface and a rechargeable battery.

Other components and capabilities encompass:

  • Optical system in a portable form factor
  • Built-in image processing
  • Capturing of color and infrared (IR) retinal images

Notably: The camera also supports DICOM-compliant image formats, enabling electronic health records (EHR) system integration for streamlined care coordination, billing, and data sharing.

So where can this be used?

The device is intended to be user-friendly, accessible, and practical—not to mention affordable—for the following clinicians and environments:

  • General healthcare providers (optometry and primary care)
  • Retail health clinics
  • Home health settings

"Our vision with the Sentinel Camera is to eliminate barriers to retinal screening and ensure that every patient who needs screening has access," stated Luke Moretti, AI Optics co-founder and CEO.

And when will it be available?

That’s to be determined—as is the price (though the company has emphasized its affordability).

Gotcha. Any other company announcements to know about?

Yes! AI Optics also announced a strategic collaboration with New York University (NYU) Langone Health, in which the duo will work to “advance the accessibility and implementation of retinal screening technology.”

  • The key goal of this partnership: Address the challenge of preventable blindness across the globe.

Also: No specific details were provided on what these plans will entail exactly; however, AI Optics disclosed that NYU Langone Health holds equity in the company.

And what else is on the agenda for AI Optics?

The company is reportedly developing AI-based retinal screening software for future integration into the Sentinel Camera.

  • The plan: To provide a comprehensive end-to-end solution for retinal disease detection.

"This FDA clearance not only validates our significant progress to breaking down screening barriers but also sets the stage for our future AI-powered screening solutions,” Moretti stated.

Lastly, this isn’t the first retinal screening technology to be cleared, is it?

Indeed it is not. In fact: In 2022, the FDA cleared AEYE Health’s AEYE Diagnostic Screening (AEYE-DS) for DR.

Fast forward to May 2024: The FDA cleared the AEYE-DS with a new indication—the first-ever fully autonomous AI portable screening for DR.

Plus, see here and here for details on a retinal camera and retinal screening tech, respectively, still in the works.

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