Digital Diagnostics vs Exo
Exo Iris is a pocket-sized ultrasound with cardiac, lung and fluid AI. Its buyers are bedside clinicians, with Fort Bend County EMS and Geisinger as the vendor's case studies. openFDA lists eight 510(k) records between August 2021 and February 2026, including Lung AI in April 2025. An August 2026 release offers a subscription-free option after a one-time activation, with the price handled through the Exo Store or its sales address.
LumineticsCore checks adults 22 or older with diabetes for more than mild diabetic retinopathy, and its indication names a single camera, the Topcon NW400. The vendor says an operator takes two images per eye and the result comes back within 30 seconds. Zufall Health and Cahaba Medical Care, both customers the vendor names, are among the sites that buy it. Its FAQ says Digital Diagnostics cannot provide pricing, sells only to healthcare providers, and points to CPT 92229 for reimbursement.
The input marks the difference: a Topcon retinal photograph for LumineticsCore, a probe held to the patient for Exo Iris.
Radiology · Reviewed November 2, 2026
Digital Diagnostics
by Digital Diagnostics Inc.
LumineticsCore: De Novo authorized autonomous AI that detects more than mild diabetic retinopathy from retinal photos.
Exo
by Exo Imaging, Inc.
Handheld ultrasound with FDA-cleared AI for cardiac, lung and fluid assessment, for point-of-care clinicians.
When to pick each one
Digital Diagnostics
- Reads retinal photos for diabetic retinopathy
- Indicated for the Topcon NW400 camera
- Reimbursable under CPT 92229, per the vendor
Exo
- Pocket ultrasound with cardiac, lung and fluid AI
- Subscription-free option after one-time activation
- Eight 510(k) records since August 2021
Score
Each row shows points earned of points available under the published rubric.
Digital Diagnostics
28of 100
Exo
28of 100
| Dimension | Digital Diagnostics | Exo | Difference |
|---|---|---|---|
| FDA clearance | 18 / 18 | 18 / 18 | 0 |
| HIPAA / SOC2 / BAA | 0 / 10 | 0 / 10 | 0 |
| EHR integrations (count) | 0 / 4.2 | 0 / 4.2 | 0 |
| Top-3 EHR coverage (Epic / Oracle / Athena) | 0 / 2.4 | 0 / 2.4 | 0 |
| Peer-reviewed papers | 0 / 18.2 | 0 / 18.2 | 0 |
| RCT / meta-analysis / systematic review | 0 / 7.8 | 0 / 7.8 | 0 |
| Funding & adoption signal | 3 / 12 | 3 / 12 | 0 |
| Pricing transparency | 2.5 / 5 | 2.5 / 5 | 0 |
| Years in market | 0 / 6 | 0 / 6 | 0 |
Scroll horizontally to see every column.
Pricing
Digital Diagnostics
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price. |
Exo
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price verified. |
Evidence
Digital Diagnostics
FDA decisions
K213037 (opens in new tab)510(k)2022-06-17
IDx-DR v2.3
K203629 (opens in new tab)510(k)2021-06-10
IDx-DR
DEN180001 (opens in new tab)De Novo2018-04-11
IDx-DR
Exo
FDA decisions
K260217 (opens in new tab)510(k)2026-02-24
AI Platform 2.2 (AIP002)
K243239 (opens in new tab)510(k)2025-04-24
Lung AI (LAI001)
K242359 (opens in new tab)510(k)2024-11-20
Strain AI (SAI001)
K240953 (opens in new tab)510(k)2024-08-05
AI Platform 2.0 (AIP002)
K232501 (opens in new tab)510(k)2023-11-17
AI Platform (AIP001)
Show 3 more
K230497 (opens in new tab)510(k)2023-06-22
Bladder AI (AIBV01)
K222198 (opens in new tab)510(k)2022-11-09
Exo Iris (EI2001)
K211527 (opens in new tab)510(k)2021-08-20
Exo Iris
Compliance and integrations
Documented from each vendor’s own pages.
| Spec | Digital Diagnostics | Exo |
|---|---|---|
| Free tier | ||
| HIPAA | ||
| SOC 2 Type II | ||
| EHR integrations | Not specified | Not specified |
| Founded | n/a | n/a |
| HQ | US | US |
Scroll horizontally to see both columns.
Common questions
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