Limbix (by BigHealth)
Evidence-based digital therapeutics for adolescent mental health and behavioral activation.
The first FDA-cleared autonomous AI for point-of-care medical diagnosis.
Digital Diagnostics (formerly IDx) represents the pinnacle of autonomous medical AI, specifically known for IDx-DR, the first-ever AI system cleared by the FDA to provide a diagnostic decision without the need for a clinician to interpret the image or results. By 2026, the technical architecture has evolved into a multi-modal platform that integrates directly into the primary care workflow, utilizing sophisticated deep learning models trained on vast datasets of retinal images. The system is designed to close the care gap for diabetic retinopathy, a leading cause of blindness, by moving the diagnostic event from specialist clinics to front-line primary care offices. Its market position is solidified through the 2026 expansion of CPT code 92229, allowing for standardized reimbursement of autonomous AI interpretations. The platform features robust DICOM compatibility, seamless EHR bi-directional integration (Epic, Cerner), and edge-computing capabilities that process high-resolution fundus images in under a minute. As a Lead AI Solutions Architect would note, its competitive advantage lies not just in its neural network accuracy, but in its rigorous clinical validation and the 'Autonomous' designation, which removes the human bottleneck in diagnostic pipelines.
A proprietary deep learning ensemble that provides a 'refer' or 'no refer' diagnostic result without human clinician over-read.
Evidence-based digital therapeutics for adolescent mental health and behavioral activation.
Predictive clinical and operational intelligence to fight death and waste in healthcare.
Predictive medical data and clinical insights for streamlined enterprise underwriting.
The professional medical network for clinicians, providing HIPAA-compliant AI and telehealth solutions.
Verified feedback from the global deployment network.
Post queries, share implementation strategies, and help other users.
Edge-AI that analyzes fundus image quality (focus, illumination, field of view) in real-time during the capture process.
Native support for HL7 and FHIR standards for seamless ingestion of patient data and export of diagnostic results.
Combines deep learning with deterministic feature-based algorithms to ensure clinical safety and explainability.
Full-stack encrypted diagnostic pipeline ensuring data at rest and in transit are protected.
System automatically generates the necessary documentation to trigger CPT code 92229 billing.
Infrastructure designed to support future autonomous modules for skin cancer and other conditions (in development).
Diabetic patients often fail to visit an ophthalmologist for their annual eye exam, leading to preventable vision loss.
Registry Updated:2/7/2026
Diagnostic report is generated in <60 seconds.
Clinician discusses results immediately and refers if necessary.
Lack of access to specialized eye care in rural or underserved areas.
Health systems struggle to meet HEDIS quality measures for diabetic eye exams.