• Strategy
  • Payers
  • AI
  • Cybersecurity
  • Device Development
  • Studies/Published Research
  • Ethics
  • Regulatory
  • Digital Biomarkers
  • Data Science
  • Companion Diagnostics
  • Clinical Care
  • Digital Therapeutics
  • Academic Research
  • Virtual Reality
  • RWE
  • Digital Endpoints
  • Medical Devices (Class II and Class III)
  • Commercialization
  • Clinical Trials
  • Drug-Device Combinations
  • SaMD
  • Remote Patient Monitoring
  • Patient Engagement
  • Profiles/Q&A

AEYE Health Eye Screening Approved


AEYE Health, an AI-based retinal imaging and diagnostics provider, has received FDA 510(k) clearance to market its diagnostic screening system for diabetic retinopathy.

The approval is based on pivotal Phase III study results demonstrating the technology's accuracy. Combined with the need to obtain only a single image per eye and the rare need to dilate, the AEYE solution is well-suited for use in primary care. In addition, screening diabetics for retinopathy using AI has recently become reimbursable in the United States using the newly approved CPT code 92229 for AI-diagnostic screening.

Over 422 million people worldwide at risk of diabetic retinopathy, a condition that is best diagnosed with a comprehensive eye exam. And more than 90% of vision loss caused by this disease can be avoided with early detection and treatment, further demonstrating a need in for easier screening at the point of care.

Read the full press release.

© 2024 MJH Life Sciences

All rights reserved.