Digital Diagnostics vs Ibex Medical Analytics (2026)
Two cleared diagnostics at opposite ends of the autonomy spectrum. Digital Diagnostics issues a diabetic retinopathy result with no physician reading the image, under the authorization that created autonomous diagnosis in the United States in 2018, with a pivotal trial run in primary care and equity built into its design. Ibex flags cancer on a slide a pathologist still signs: its Galen Second Read clearance rests on a reader study of 772 cases read by 12 pathologists at four sites, in which sensitivity rose with the device, and its trust center publishes a business associate addendum and names ISO 27001, HITRUST and other certifications. Neither competes with the other clinically. Together they mark the two poles a buyer should keep distinct: a product that decides needs pivotal evidence in the population it will serve, and a product that assists needs to show clinicians do better with it.
- It issues a diagnosis with no clinician reading the image, under the authorization that created the category in 2018.
- Equity was an input to its pivotal trial design rather than a disclosure added afterward.
- There is a reimbursement pathway for the workflow rather than a value argument, which decides whether a primary care clinic runs the test at all.
- Its trust center publishes a business associate addendum that reaches subcontractors and names ISO 27001, HITRUST and BSI C5 among its certifications, with reports on request.
- The Galen Second Read clearance rests on a multi site reader study of 772 cases, with pathologists' sensitivity rising from 90.5 to 93.9 percent with the device.
- For a laboratory signing out cancer diagnoses, the published reader study and business associate terms answer the questions procurement will ask first.
This comparison is published by AI Health Index, an independent research platform that compares healthcare AI vendors objectively. Digital Diagnostics and Ibex Medical Analytics 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 | Ibex Medical Analytics |
|---|---|---|
| Primary category | Diagnostics & Genomics | Digital Pathology AI |
| Founded | 2010 | 2016 |
| Headquarters | Coralville, Iowa, United States | Tel Aviv, Israel |
| Website | digitaldiagnostics.com | ibex-ai.com |
Side by Side
Select any grade to read the note behind it.
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
Cancer diagnostics company selling Galen, AI applications that analyze H&E whole slide images for prostate, breast and gastric cancer and return results into laboratories' existing image management and laboratory systems through partners including Roche, Philips, Proscia and Sectra.
Source: AI Health Index, September 2026
Questions buyers ask
How do Digital Diagnostics and Ibex Medical Analytics 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 Ibex Medical Analytics, the 510(k) summary describes the cleared product ingesting slides automatically from the scanner and image management system, with the diagnosis documented in another system such as the LIS. From the AI Health Index, drawn from each vendor's own published materials and the regulatory record, verified September 28, 2026. No vendor pays for placement.
How do Digital Diagnostics and Ibex Medical Analytics 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.
The Data Protection Addendum (last updated February 2026), linked from the trust center, lets Ibex delete customer personal data 21 days after receipt unless a different period is agreed in the purchase confirmation, and requires deletion from Ibex's and its sub-processors' systems at termination or on written request. From the AI Health Index, drawn from each vendor's own published materials and the regulatory record, verified September 28, 2026. No vendor pays for placement.
Which settings and specialties do Digital Diagnostics and Ibex Medical Analytics 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 Ibex Medical Analytics' case, the company sells Galen for prostate, breast and gastric biopsies and says its models were developed from more than 10 million slides from multiple pathology institutes. From the AI Health Index, drawn from each vendor's own published materials and the regulatory record, verified September 28, 2026. No vendor pays for placement.
What evidence is published for Digital Diagnostics and Ibex Medical Analytics?
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 Ibex Medical Analytics, the Galen Second Read 510(k) summary (K241232) reports a standalone study on 347 benign-diagnosed cases at three sites and a reader study on 772 cases (396 with cancer, 376 benign) read by 12 pathologists at four sites, three in the United States, each case read with and without the device after a two week washout. From the AI Health Index, drawn from each vendor's own published materials and the regulatory record, verified September 28, 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.
The two occupy opposite ends of the autonomy spectrum in diagnostics and that is the substance of the comparison: one issues a result with no clinician in the loop, the other flags suspicious tissue on a slide a pathologist signs. The evidence demanded should differ accordingly. Digital Diagnostics publishes no security attestation of any kind and no business associate terms for provider customers; Ibex publishes its business associate addendum. In Ibex's reader study specificity fell with the device while sensitivity rose, and in pathology, staining and scanner variation between laboratories remains a large uncontrolled variable.