Notal Vision Home OCT lets patients scan their own retinas at home

In the five-week study that FDA reviewed, patients' home OCT scans agreed with clinic scans on retinal fluid, with a PPA of 0.864 and an NPA of 0.849. No gain in vision was shown.

  • Not rated a person

    Patients imaged themselves at home in the study, and FDA states that it has not been demonstrated whether the benefits will result in improved visual outcomes.

Depth runs from 1, a convenience or time saved, to 5, a life or a livelihood preserved.

Status
Intended benefit.
Evidence

foundstudiedreportedclaimed

An independent regulatory document supports the benefit.

Compared with

Clinic OCT scans graded by the reading center within 24 hours. Measured.

The system’s part
Not isolated. The agreement figures come from graders at a reading center who read the home scans, so they measure the imaging. The AI's own outlines were compared with graders in a separate study, and no study compared care with and without the device.
Limits
Not yet checked.
Costs and harms
Not yet checked.
Later
Not yet checked.

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Benefit type
Improved Physical Health
System
Notal Vision Home Optical Coherence Tomography (OCT) System with the Notal OCT Analyzer (NOA)
Made by
Notal Vision, Inc.
Used by
Notal Vision (001 Study at seven US sites, with patients imaging themselves at home, and 006 Study at six US sites)
Where
Patients' homes and seven US clinical sites (001 Study); six US sites (006 Study)
Stage
In a pilot
Date
, when the source was published
Kind
Aggregate result
Broad benefit
Estimating the Quantifiable Characteristics of Products, Events, or Information, Monitoring Processes, Materials, or Surroundings
Collections
Scrutiny and findings
Last revised
31 October 2026

Sources

  1. Regulatory document, by authors with no tie to the system.

    U.S. Food and Drug Administration, Center for Devices and Radiological Health. De Novo classification request for Notal Vision Home Optical Coherence Tomography (OCT) System (DEN230043): decision summary. Granted 2024-05-15.

    The PPA was 0.864 (95% CI 0.802, 0.926; p=0.043)

Details

AI system

Workflow

Patients set up the device with an on-screen tutorial and imaged themselves every day for five weeks. Remote technical support was available, and the reading center reviewed daily scans.

Follow-up

Conditions for replication

The patient must have visual acuity of 20/320 or better and be able to calibrate the device. Home scans must not replace or delay scheduled clinic visits.

Entry details

Sector

Healthcare.

Purpose

Notal Vision built the Home OCT System to let patients with neovascular age-related macular degeneration image their retinas at home between clinic visits. Its AI marks fluid-like spaces for their physicians.

Not yet checked: model, release, provider, role, configuration, inputs and outputs, autonomy, human oversight, AI contribution, beneficiaries, reach, distribution and access, duration, every measurement question, every money question, ownership and control, dependencies, cross-border connections, geopolitical implications, replication attempts, availability, institutional decision, grounds, action and result, success criterion, every evidence question, observed or intended, alternative assessments, related entries, other identifiers, category mappings.

Cite this record

Peter H. Vartanian. (2026). Notal Vision Home OCT lets patients scan their own retinas at home (AIBD-0768). Artificial Intelligence Benefits Database, edition of 31 October 2026. https://petervartanian.xyz/aibd/records/AIBD-0768.html (archived at https://doi.org/10.7910/DVN/AADSII, version 4.0)

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