Digital Diagnostics vs Eko Health (2026)
Both bring cleared AI diagnosis into primary care, and they differ in who makes the call. Digital Diagnostics' LumineticsCore detects more than mild diabetic retinopathy from retinal images and returns a result at the point of care with no physician reading the image: refer to an eye care professional, rescreen in 12 months, or image quality insufficient. In 2018 it became the first autonomous AI diagnostic system authorized by FDA. Eko Health's digital stethoscopes record heart sounds and a single lead ECG during a routine exam, and cleared models flag structural murmurs, atrial fibrillation and low ejection fraction. The result goes to a clinician, including when a nurse or medical assistant captured the recording. Digital Diagnostics decides on its own inside a narrow, validated task; Eko assists a clinician across several heart findings.
- Diabetic retinopathy detection that returns a result at the point of care without a physician reading the image.
- The first autonomous AI diagnostic system authorized by FDA, through De Novo in 2018, with later 510(k)s.
- Three clear outputs: refer, rescreen in 12 months, or image quality insufficient.
- Digital stethoscopes and cleared models for murmurs, atrial fibrillation and low ejection fraction.
- Capture by medical assistants and nurses at intake, with a clinician reading the result.
- A published clinician price of $119.99 a year for Eko+.
This comparison is published by AI Health Index, an independent research platform that compares healthcare AI vendors objectively. Digital Diagnostics and Eko Health are each graded against the same capability taxonomy, from each vendor's own public materials and the regulatory record, under the AI Health Index verification standard. No vendor pays for placement, and no vendor has reviewed this page. How this evidence is graded
Plain facts
| Fact | Digital Diagnostics | Eko Health |
|---|---|---|
| Primary category | Diagnostics & Genomics | Diagnostics & Genomics |
| Founded | 2010 | 2013 |
| Headquarters | Coralville, Iowa, United States | Emeryville, California |
| Website | digitaldiagnostics.com | ekohealth.com |
Side by Side
Select any grade to read the note behind it.
Product updates
The latest logged changes from each vendor, newest first, each linked to its source.
Eko Health
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Product / capability
Eko launched CORE 300, an FDA cleared stethoscope whose single chestpiece twists between traditional listening and Cardiac, Pulmonary and All Purpose digital modes, with up to 35 times amplification, active noise cancellation and an on device heart rate display.
Source
Each vendor in one paragraph
Written to be quoted whole. Each paragraph opens the AI Health Index profile of the vendor: what the product is, who buys it and what it does.
Digital Diagnostics, founded in Coralville, Iowa as IDx Technologies by retina specialist and computer engineer Michael Abramoff, MD, PhD, builds autonomous AI diagnostic systems. Its flagship, LumineticsCore (cleared as IDx-DR), detects more than mild diabetic retinopathy including macular edema from retinal images and returns a result at the point of care without physician interpretation of the image: refer to an eye care professional, rescreen in 12 months, or insufficient image quality.
Source: AI Health Index, September 2026
Eko Health makes digital stethoscopes and FDA-cleared software that analyzes heart sounds and a single-lead ECG recorded during a routine exam. The models flag structural heart murmurs in adults and children, atrial fibrillation in adults, and low ejection fraction (40 percent or below) in adults at risk of heart failure.
Source: AI Health Index, September 2026
Questions buyers ask
How do Digital Diagnostics and Eko Health work with the EHR?
For Digital Diagnostics, the regulatory record for the current versions describes DICOM image submission, and results reach the provider through the company's systems, including SphereDx, which it lists as a diagnostic results platform.
With Eko Health, the product's Medicare billing needs a documented overread, and nothing published says how results and that review reach the chart. From the AI Health Index, drawn from each vendor's own published materials and the regulatory record, verified September 29, 2026. No vendor pays for placement.
How do Digital Diagnostics and Eko Health handle patient data?
In Digital Diagnostics' case, the 2022 clearance summary (K213037) shows the path the data takes: client software sends images to analysis on dedicated servers hosted in a secure datacenter, so images leave the site.
For Eko Health, the enterprise terms and conditions give Eko a perpetual, irrevocable, royalty-free license to use customer data in de-identified or aggregated form for any purpose, naming the development of its algorithms, and assign it all rights in aggregated statistics. From the AI Health Index, drawn from each vendor's own published materials and the regulatory record, verified September 29, 2026. No vendor pays for placement.
Which settings and specialties do Digital Diagnostics and Eko Health cover?
With Digital Diagnostics, the pivotal trial ran prospectively at primary care sites, so the setting of use is the setting validated. Pediatric evidence exists (the SEE study) and is outside the authorized indication.
In Eko Health's case, the clinical scope is cardiac detection: structural murmur for adults and children, atrial fibrillation for adults, and low ejection fraction for adults at risk of heart failure, with capture by medical assistants and nurses at intake. Primary care is validated in the UK trial and the prospective US valve study, and each cleared model has its own validation population. From the AI Health Index, drawn from each vendor's own published materials and the regulatory record, verified September 29, 2026. No vendor pays for placement.
What evidence is published for Digital Diagnostics and Eko Health?
For Digital Diagnostics, the SEE study (Diabetes Care, 2021) extended safety, efficacy and equity testing to a youth population outside the authorized indication. A review in Ophthalmology Science assessed LumineticsCore alongside EyeArt and AEYE Diagnostic Screening and gathered implementation experience from academic health systems, which places the product in a third party comparison.
With Eko Health, an independent evaluation at Oregon Health and Science University (International Journal of Cardiology, 2025) found the earlier murmur model detected valve disease with 39.3 percent sensitivity and 82.3 percent specificity against echocardiography in 1,029 patients. From the AI Health Index, drawn from each vendor's own published materials and the regulatory record, verified September 29, 2026. No vendor pays for placement.
Related comparisons
Other published head to head assessments involving these vendors or their closest peers. The full set for this category is on the Diagnostics & Genomics page.
Both records were reviewed on this site in September 2026. Eko publishes its clinician price; Digital Diagnostics does not publish one.
Ask Digital Diagnostics who is accountable when an autonomous result is wrong, and ask Eko what share of flagged patients go on to confirmed disease.