We believe diagnostic AI must meet the same evidentiary standard as any other clinical decision support tool — rigorous validation, transparent methodology, and radiologist control at every step.
Diagnosify was founded in 2021 by a team of diagnostic radiologists, computer vision researchers, and clinical informaticists who had spent careers at the intersection of medical imaging and computational analysis.
The founding team observed a consistent pattern across academic medical centers: imaging volume was growing faster than radiologist capacity, and existing software tools were not designed to close the gap with clinical rigor. They set out to build something different — a system validated on real patient populations, designed to reduce diagnostic errors rather than introduce them.
After three years of clinical research collaboration with twelve academic medical centers, Diagnosify launched its commercial platform in 2024 with FDA 510(k) clearance already in hand.
Four principles that guide every product decision, clinical study, and customer engagement.
Performance claims are grounded in prospective studies with pre-registered endpoints. We do not publish sensitivity without specificity. We do not claim generalizability without diverse validation cohorts.
Our models are designed to augment radiologist judgment, not replace it. Every finding includes a confidence score, and radiologists retain full override authority with documented audit trails.
Clinical value is only realized when AI tools fit within existing workflows. We optimize for sub-10-second inference, zero-footprint integration, and minimal change management burden on clinical staff.
All validation studies are published in peer-reviewed journals with full methodology disclosure. Model limitations, known failure modes, and edge case performance are documented and shared with customers.
Clinical scale achieved through rigorous research collaboration and commercial deployment.
Diagnosify's Scientific Advisory Board comprises radiologists, medical informaticists, and clinical AI researchers from leading academic institutions in the United States and Europe.
The board provides independent review of our validation study designs, evaluates model performance claims, and advises on emerging regulatory guidance from the FDA, EMA, and international standards bodies.
Advisory board members are disclosed in our annual transparency report, published each January.
Read the Transparency Report