Notal Vision Home Optical Coherence Tomography (OCT) System
Overview
The Notal Vision Home Optical Coherence Tomography (OCT) System, also known as SCANLY Home OCT, is an Artificial Intelligence (AI)-based, patient self-operated device designed for the remote monitoring of neovascular age-related macular degeneration (NV-AMD) between scheduled clinic visits. The system comprises the SCANLY Home OCT device and the Notal Health Cloud. Patients use the compact device at home to capture spectral-domain OCT images, typically in less than one minute per eye. These images are automatically transmitted via a built-in wireless connection to the Notal Health Cloud for analysis.
The proprietary, AI-based Notal OCT Analyzer (NOA) performs automated detection, segmentation, and estimation of the volume of intraretinal and subretinal hypo-reflective spaces (HRS), which are crucial biomarkers in managing NV-AMD. Physicians can access and review patient data, including annotated B-scans and trends in HRS volume, through a secure, HIPAA-compliant web portal (SCANLY Portal). The system allows physicians to set eye-specific notification criteria and receive alerts when fluid levels suggest disease reactivation, enabling personalized, on-demand treatment decisions. The Notal Vision Monitoring Center provides comprehensive support, including patient education, training, insurance verification, and adherence monitoring, ensuring ease of use for both patients and practices.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- Patient self-operated home OCT device
- AI-based Notal OCT Analyzer (NOA) for automated image analysis
- Visualization and quantification of intraretinal and subretinal hypo-reflective spaces (biomarkers for nvAMD)
- Automatic transmission of images to Notal Health Cloud via wireless connection
- HIPAA-compliant web portal (SCANLY Portal) for physicians
- Physician-set notification criteria and alerts for changes in fluid levels
- Comprehensive remote patient monitoring service by Notal Vision Monitoring Center
- Support for insurance verification, patient enrollment, training, and adherence monitoring
- Established CPT codes for remote OCT billing
- High-resolution spectral-domain OCT imaging
Use Cases
- Monitoring neovascular age-related macular degeneration (NV-AMD) between office visits
- Enabling personalized treatment decisions based on real-time disease activity
- Early detection of disease reactivation (e.g., fluid buildup)
- Reducing treatment burden and optimizing in-office visit frequency
- Providing continuous insights into disease status for retina specialists
- Complementing existing standard of care treatments for wet AMD
What Physicians Need to Know
The SCANLY Home OCT offers a valuable tool for personalized, continuous monitoring of neovascular AMD patients between office visits, potentially reducing treatment burden and improving disease insights. Physicians should clearly communicate that this device is for monitoring diagnosed nvAMD and not for initial diagnosis or replacing scheduled in-office examinations or treatment decisions. Setting individualized fluid volume thresholds for alerts through the Notal Vision Monitoring Center portal is crucial for effective patient management. Consider patient visual acuity (20/320 or better recommended for successful self-imaging) and cognitive ability for optimal adherence and image quality.
The system integrates seamlessly with the Notal Health Cloud for automated image transmission and AI analysis by the Notal OCT Analyzer (NOA). Data and physician notifications are accessible via a HIPAA-compliant web portal. The Notal Vision Monitoring Center provides comprehensive support, including patient enrollment, device setup, and adherence monitoring, effectively extending the clinic's reach into the patient's home. The system supports a remote patient monitoring paradigm, complementing existing standard-of-care treatments.
Details
| Category | Ophthalmology AI, Wearables & Remote Monitoring (RPM) |
| Pricing |
No direct cost to the practice; billed to the patient or their insurance.
|
| Deployment | Cloud-based (Notal Health Cloud) with a patient-operated hardware device and a web-based physician portal. |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
1 AI-estimated Granted De Novo authorization (DEN230043) on May 15, 2024, as a Class II home monitoring ophthalmic imaging device. It is indicated for visualization, segmentation, and estimation of intraretinal and subretinal hypo-reflective spaces in eyes diagnosed with neovascular age-related macular degeneration (NV-AMD). |
| Integrations | |
| EHR | Not specified |
| Specialties | Ophthalmology |
What the Web Says
The Notal Vision Home Optical Coherence Tomography (OCT) System, marketed as SCANLY, is an FDA-approved, patient-operated device designed for remote monitoring of neovascular age-related macular degeneration (nAMD). It allows patients to perform daily self-scans at home, which are then analyzed by an AI-based algorithm (Notal OCT Analyzer or NOA) for fluid detection and quantification. Physicians can access this data through a secure web portal, enabling more personalized and timely treatment decisions, potentially reducing the burden of frequent in-office visits for patients and healthcare providers.
Overall: PositiveStrengths
- Enables daily self-monitoring of nAMD from home, reducing the need for frequent office visits.
- High patient usability and adherence, with studies showing high success rates for self-imaging (91-97%) and consistent scanning.
- AI-powered analysis (NOA) provides reliable and repeatable detection and quantification of retinal fluid, comparable to expert graders and in-office devices.
- Facilitates more personalized and optimized treatment decisions by providing physicians with continuous, real-world data on disease activity.
- Potential for significant cost savings to the healthcare system by avoiding unnecessary treatments and optimizing visit schedules.
- Reduces patient and caregiver burden associated with frequent travel to clinics for monitoring.
Limitations
- Some disagreement (17%) between the AI algorithm and human expert graders on fluid status, particularly involving subretinal fluid.
- The generalizability of some study findings may be limited by the relatively small number of physicians, patients, and eyes included.
- While FDA-cleared, the SCANLY Home OCT is not yet widely available.
- Physician decisions in some studies were based solely on anatomical data from home OCT, without visual acuity changes, which may not reflect all clinical considerations.
- The cost of the device and monitoring program for patients and the healthcare system is a factor, though potential savings are also highlighted.
- Initial concerns from physicians about troubleshooting issues and data accessibility, though these were largely alleviated with Notal Vision's support.
Based on reviews from: vertexaisearch.cloud.google.com, Ophthalmology Retina, Ophthalmology Science, Journal of VitreoRetinal Diseases, Retina, Review of Optometry, Retinal Physician, Ophthalmology Management, Macular Degeneration Association, The Ophthalmologist
Last updated: 2026-07-18
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