Companies
iHealthScreen
recently received FDA 510(k) clearance (K253704) for iPredict DR, AI-powered software for automated diabetic retinopathy screening.
- Country
- United States
Growth
iPredict DR
Coverage
| CN | EU | US | |
|---|---|---|---|
| diagnostics-medtech | ✓ | ✓ | ✓ |
Regulatorsfdaemanmpa
Verifiable facts
| Fact | Value | Source |
|---|---|---|
| Funding | $3.45 million (2026-05-13) | ihealthscreen.org · physicianaitools.com |
| Regulatory approval | FDA 510(k) clearance for iPredict-DR (K253704) (2026-07-02) | fda.innolitics.com · businesswire.com · morningstar.com |
| Certification | CE certification for screening AMD, DR, and Glaucoma (2026-09-01) | ihealthscreen.org · physicianaitools.com |
| Regulatory approval | Regulatory approvals in Australia (TGA), UK (MHRA), and UAE (2026-09-01) | ihealthscreen.org · physicianaitools.com |
| Revenue | $660,339 annual revenue (2024) (2024-12-31) | sec.gov |
| Production site | Richmond Hill, New York (Headquarters); Melbourne, Australia; Abu Dhabi, UAE; Dhaka, Bangladesh | ihealthscreen.org |
Independent sources: businesswire.com · fda.innolitics.com · morningstar.com · physicianaitools.com · sec.gov
Technologies
| Name | Cluster | Risk | |
|---|---|---|---|
| AI optical coherence tomography screening | diagnostics-medtech | Low | → |
Compiled by BIOECON from primary sources.
Compliance
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