Digital Diagnostics
Founded 2010 · 66 employees on LinkedIn · 11 known investors
Healthcare technology company whose FDA-cleared autonomous AI diagnoses diabetic retinopathy from retinal images at the point of care.
Also known as Digital Diagnostics Inc. · IDx · IDx-DR
Founders & leadership
Investors · 11
Also in the syndicate · 6
Company profile
researched Aug 2026Digital Diagnostics is a healthcare technology company that builds artificial intelligence systems that diagnose disease by analyzing high-quality medical images. Its flagship product, LumineticsCore (formerly IDx-DR), is an autonomous AI diagnostic system that detects diabetic retinopathy, including diabetic macular edema, from fundus images without requiring a physician to review the images. Results are returned within 30 seconds of image submission, allowing primary care and other non-specialty sites to deliver a specialty-level exam and refer onward only the patients who need follow-up care. The company also offers SphereDx, a hosted platform for delivering diagnostic results from Digital Diagnostics systems, and training courses for the Luminetics product line.
The company positions its work around bioethical principles and has worked with regulators, providers, payers and patient advocacy groups to establish autonomous diagnosis as a standard of care. Cited industry firsts include the first FDA De Novo clearance for an autonomous AI diagnostic, real-world clinical launch and EHR integration of such a system, and creation of CPT category 1 code 92229 for autonomous AI billing and payment. LumineticsCore is referenced in the American Diabetes Association's 2020 Standards of Care in Diabetes and in the American Academy of Ophthalmology's diabetic retinopathy Preferred Practice Pattern. Research efforts extend to additional uses of fundus imaging, including glaucoma, and to disease detection beyond the eye.
Founding story
The company was originally founded by Michael Abramoff, MD, PhD, a fellowship-trained retina specialist, computer scientist and neuroscientist who is a professor of ophthalmology and visual sciences at the University of Iowa with a joint appointment in the College of Engineering. LumineticsCore was the AI diagnostic platform he had envisioned years earlier, and the company was later led in partnership with co-founders John Bertrand (CEO) and Seth Rainford (President and COO).
Business model
Digital Diagnostics sells AI diagnostic systems to healthcare providers, with LumineticsCore deployed in clinical settings such as primary care, value-based care groups and retail locations, integrated with electronic medical record systems including Epic. Provider adoption is supported by reimbursement under CPT code 92229 and by quality-measure benefits under HEDIS, MIPS and Stars ratings, plus the hosted SphereDx results platform and product training offerings.
Revenue derives from provider adoption of its AI diagnostic systems, supported by third-party reimbursement of autonomous AI exams under CPT code 92229, alongside the SphereDx results platform and product training.
Traction
Published case studies report clinical and operational results: diabetic retinal exam adherence at Johns Creek Primary Care rose from 16.2% to 50.7% year over year; at Cahaba Medical Care one in three people tested were diagnosed with diabetic retinopathy within 90 days; Urban Health Plan moved from 40% below its target of 1,000 annual eye exams for diabetes every six months to 60% above target; at Tarzana Treatment Centers time-to-follow-up fell from 60 days with a remote reading network to 5 days; in one health system annual eye exam rates rose from 65.2% to 72.8%, above the 90th percentile HEDIS benchmark of 67.89%; and 30.3% of patients referred after an AI-based exam followed up at a university eye institute versus 11.5% after teleophthalmology. A randomized trial in Bangladesh reported a 40% productivity gain for medical caregivers using autonomous AI. As of August 2022 the company reported accelerating commercial traction and total capital raised of more than $130 million.
Latest developments
In August 2022 the company closed a $75 million Series B round led by KKR, with Ali Satvat of KKR and Stephen Weiss of Cedar Pine joining the board, and stated the proceeds would fund the product roadmap, distribution expansion and sales and marketing. Luke Miller, previously Chief Legal Officer, Chief Compliance Officer and Corporate Secretary from 2021 to 2025, is listed as Chief Executive Officer, and the company says it is launching additional AI platforms for detecting a range of diseases in the eye and beyond.
▸Full profile — market position, technology, go-to-market, geography, history
Market position
The company describes itself as a leader in healthcare AI and states that LumineticsCore is the most researched autonomous AI diagnostic solution for diabetic eye disease and the first FDA De Novo cleared autonomous AI in health care. Its systems are in use at health systems across the United States.
Digital Diagnostics emphasizes being the first company to obtain FDA clearance for an autonomous AI that diagnoses at the point of care without physician input, an explicit bioethical design framework, an established reimbursement pathway through CPT code 92229, inclusion in ADA and AAO clinical guidance, and a body of real-world evidence and peer-reviewed publications supporting its diabetic eye disease product.
Technology
Autonomous AI algorithms analyze retinal (fundus) camera images to produce a diagnosis of diabetic retinopathy and macular edema without physician interpretation, returning a result within about 30 seconds. The system was validated in a prospective, preregistered clinical trial and received FDA De Novo clearance; it integrates with electronic medical records such as Epic, and results are delivered through the SphereDx hosted platform. Research is under way on additional fundus-image-based diagnostics, including glaucoma.
Go-to-market
The company sells directly to healthcare providers and health systems, supports deployment with EMR integration and operator training, and works with regulators, payers, quality organizations and patient advocacy groups to secure reimbursement and quality-measure recognition. It publishes case studies and peer-reviewed research as commercial evidence and stated in 2022 that it would expand its distribution footprint and sales and marketing capacity.
Primary care practices, community health centers, health systems, value-based care groups and retail healthcare locations serving patients with diabetes; named users include Tarzana Treatment Centers, Cahaba Medical Care, Johns Creek Primary Care, Zufall Health Center, OSF HealthCare, AbsoluteCare, Urban Health Plan, University Medical Center and Stanford Health System.
Geography
Headquartered in Coralville, Iowa, with deployments at health systems across the United States; published research also covers a randomized trial conducted in Bangladesh.
History
The company grew out of decades of research by founder Michael D. Abramoff, MD, PhD, on automated image analysis and on how clinicians diagnose disease. In April 2018 it became the first company to receive FDA clearance for an AI diagnostic platform that makes a diagnosis at the point of care without physician input, following a prospective, preregistered clinical trial at primary care sites. Subsequent milestones include creation of CPT code 92229 in 2019, an NCQA clarification to HEDIS measures in 2019 confirming use of autonomous AI for diabetic retinopathy diagnosis, inclusion in the ADA's 2020 Standards of Care in Diabetes, a CMS proposed rule in August 2020 covering CPT 92229 in a reimbursable primary care setting, publication of an ethical framework for autonomous AI by Dr. Abramoff in November 2020, and a CMS language update in early 2023 replacing "automated diagnosis" with "autonomous diagnosis." The product was rebranded from IDx-DR to LumineticsCore.
Compiled by commissioned research from 8 cited public sources — announcements, filings, and press listed under research sources below.
Key figures
latest reportedCompany-reported or press-reported figures, each dated to when it was claimed — not independently audited.
Timeline · 8
launches, deals, and filingsLuke Miller, who served as Digital Diagnostics' Chief Legal Officer, Chief Compliance Officer and Corporate Secretary from 2021 to 2025, is listed as Chief Executive Officer.
CMS replaced "automated diagnosis" with "autonomous diagnosis" in the language for CPT code 92229, defining autonomous AI as diagnosis or clinical management decisions that do not require physician intervention.
The round brought total capital raised to more than $130 million and added KKR's Ali Satvat and Cedar Pine's Stephen Weiss to the board of directors. Proceeds were designated for the product roadmap, distribution expansion, and sales and marketing.
$75M source ↗
The Centers for Medicare and Medicaid Services published a proposed rule for coverage of CPT code 92229, permitting use of autonomous AI in a reimbursable primary care setting.
CPT code 92229 was established as the first autonomous AI category 1 code for billing and payment.
The National Committee for Quality Assurance issued a clarification to its HEDIS measures confirming the use of autonomous AI to diagnose diabetic retinopathy.
Digital Diagnostics received FDA clearance (De Novo) for IDx-DR, later renamed LumineticsCore, becoming the first company with an AI diagnostic platform that makes a diagnosis at the point of care without physician input, following a prospective, preregistered clinical trial at US primary care sites.
Dated company events from announcements, filings, and press; legal rows summarize public dockets and regulator releases.
In the news
▸Research sources · 8
primary sources listed
- Digital Diagnosticsdigitaldiagnostics.com · web
8 public sources were cited for this profile; the first-party ones are listed here.
Frequently asked questions
- What does Digital Diagnostics do?
- Healthcare technology company whose FDA-cleared autonomous AI diagnoses diabetic retinopathy from retinal images at the point of care.
- Who are Digital Diagnostics's investors?
- Digital Diagnostics's investors include 8VC, Alpha Edison, Optum Ventures, OSF Ventures, Kinderhook.