Clarius vs Digital Diagnostics
An obstetrics office is Clarius's buyer. The scanner shows its image on a phone or tablet, and the vendor says OB AI returns BPD, HC, AC and FL measurements. openFDA names Clarius OB AI alongside Bladder AI and Prostate AI.
A primary care clinic with a diabetic panel is LumineticsCore's buyer. The vendor says it diagnoses more than mild diabetic retinopathy from retinal photos in adults 22 or older with diabetes and no prior retinopathy diagnosis. Its indication names the Topcon NW400 camera, with two photos per eye. FDA granted De Novo DEN180001 in April 2018, and the product code PIB is titled diabetic retinopathy detection device. The vendor sells only to healthcare providers.
The two do different jobs. Clarius is ultrasound at the visit and LumineticsCore is retinal photography, so owning both would mean two separate workflows.
Radiology · Reviewed November 2, 2026
Clarius
by Clarius Mobile Health
Wireless handheld ultrasound scanners with FDA-cleared onboard AI tools for bladder, prostate, OB and cardiac measurement.
Digital Diagnostics
by Digital Diagnostics Inc.
LumineticsCore: De Novo authorized autonomous AI that detects more than mild diabetic retinopathy from retinal photos.
When to pick each one
Clarius
- Handheld scanner with the image shown on a phone or tablet
- Vendor says OB AI measures BPD, HC, AC and FL
- Bladder AI and Prostate AI have separate FDA decisions
Digital Diagnostics
- De Novo DEN180001, product code PIB for retinopathy detection
- Vendor indication names the Topcon NW400 camera
- Vendor says the result arrives within 30 seconds
Score
Each row shows points earned of points available under the published rubric.
Clarius
53of 100
Digital Diagnostics
28of 100
| Dimension | Clarius | Digital Diagnostics | 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 | 12.7 / 18.2 | 0 / 18.2 | +12.7 |
| RCT / meta-analysis / systematic review | 7.8 / 7.8 | 0 / 7.8 | +7.8 |
| 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
Clarius
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price verified. |
Digital Diagnostics
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price. |
Evidence
Clarius
FDA decisions
K253593 (opens in new tab)510(k)2026-03-02
Clarius Ejection Fraction AI
K250226 (opens in new tab)510(k)2025-05-08
Clarius Median Nerve AI
K243853 (opens in new tab)510(k)2025-04-16
Clarius Prostate AI
K233955 (opens in new tab)510(k)2024-06-14
Clarius OB AI
K232257 (opens in new tab)510(k)2023-11-13
Clarius Bladder AI
Show 1 more
K222406 (opens in new tab)510(k)2023-01-23
Clarius AI
Peer-reviewed
3 PubMed records name Clarius.
- Can handheld ultrasound probes reliably measure transabdominal prostate and bladder volumes? A prospective randomized point-of-care ultrasound study. (opens in new tab)
- Artificial Intelligence-Assisted Lung Ultrasound for Pneumothorax: Diagnostic Accuracy Compared with CT in Emergency and Critical Care. (opens in new tab)
- Validation of Handheld Ultrasound Devices for Point of Care Use in Rheumatology Study- Focus on Synovitis, Doppler Activity, Erosions, and Tendon Lesions. (opens in new tab)
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
Compliance and integrations
Documented from each vendor’s own pages.
| Spec | Clarius | Digital Diagnostics |
|---|---|---|
| Free tier | ||
| HIPAA | ||
| SOC 2 Type II | ||
| EHR integrations | Not specified | Not specified |
| Founded | n/a | n/a |
| HQ | n/a | US |
Scroll horizontally to see both columns.
Common questions
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