News

Article

AI Optics’ portable Sentinel Camera gains FDA 510(k) clearance

Key Takeaways

  • AI Optics' Sentinel Camera offers portable, high-quality retinal imaging without eye dilation, improving access to screening.
  • The device supports DICOM-compliant formats, facilitating integration with Electronic Health Record systems.
SHOW MORE

The Sentinel Camera aims to address critical gaps in retinal disease screening by offering a portable device that captures high-quality images that require no dilation of the eye.

(Image Credit: AdobeStock/Mohwet)

(Image Credit: AdobeStock/Mohwet)

AI Optics, an AI-focused medical device company, has received FDA 510(k) clearance for its Sentinel Camera, a handheld retinal imaging system.

The Sentinel Camera aims to address critical gaps in retinal disease screening by offering a portable device that captures high-quality images that require no dilation of the eye. According to the company, this eliminates the need for some patients to visit an eye specialist’s office. Additionally, the Sentinel Camera supports DICOM-compliant image formats, allowing integration with Electronic Health Record (EHR) systems.

Luke Moretti, co-founder and CEO of AI Optics, commented on the device and clearance in a press release from the company.

AI Optics FDA Cleared Sentinel Camera (Courtesy AI Optics)

AI Optics FDA Cleared Sentinel Camera (Courtesy AI Optics)

"Our vision with the Sentinel Camera is to eliminate barriers to retinal screening and ensure that every patient who needs screening has access," said Moretti "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, which will integrate seamlessly with the Sentinel Camera to deliver unparalleled accessibility and efficiency in retinal disease detection."

In addition to the clearance, AI Optics is developing AI-based retinal screening software for future integration. The company aims to provide a comprehensive end-to-end solution for detecting retinal diseases such as diabetic retinopathy, glaucoma, and macular degeneration.

AI Optics is also collaborating with NYU Langone Health with the goal of advancing the accessibility and implementation of retinal screening technology. According to the company, this clearance “marks a pivotal step in this journey, enabling the integration of high-quality, portable imaging into diverse healthcare environments.”

References:
  1. AI Optics Receives FDA Clearance, Increasing Patient Access to Retinal Screening. Press Release. Published January 28, 2025. Accessed January 28, 2025.https://investors.apellis.com/news-releases/news-release-details/apellis-receives-approval-syfovrer-pegcetacoplan-australia

Newsletter

Don’t miss out—get Ophthalmology Times updates on the latest clinical advancements and expert interviews, straight to your inbox.

Related Videos
(Image credit: Ophthalmology Times) NeuroOp Guru: Using OCT to forecast outcomes in ethambutol optic neuropathy
(Image credit: Ophthalmology Times) Dilsher Dhoot, MD, on the evolution of geographic atrophy therapy: where are we now?
(Image credit: Ophthalmology Times Europe) Anat Loewenstein, MD, shares insights on the real-world results of remote retinal imaging
(Image credit: Ophthalmology Times) Two-wavelength autofluorescence for macular xanthophyll carotenoids with Christine Curcio, PhD
(Image credit: Ophthalmology Times) FLIO and the brain: Making the invisible visible with Robert Sergott, MD
(Image credit: Ophthalmology Times) Structure-function correlates using high-res OCT images with Karl Csaky, MD, PhD
(Image credit: Ophthalmology Times) SriniVas Sadda, MD, on high-res OCT of atrophic and precursor lesions in AMD
(Image credit: Ophthalmology Times) Christine Curcio, PhD, shares histology update supporting review software and revised nomenclature for <3 μm OCT
© 2025 MJH Life Sciences

All rights reserved.