# iHealthScreen

recently received FDA 510(k) clearance (K253704) for iPredict DR, AI-powered software for automated diabetic retinopathy screening.

Source: https://en.bioecon.ru/companies/ihealthscreen/
Updated: 2026-07-20

- Country: United States

## Verifiable facts

| Fact | Value | Source |
| --- | --- | --- |
| Funding | $3.45 million (2026-05-13) | https://ihealthscreen.org/investors/executive-summary, https://physicianaitools.com/companies/ihealthscreen/ |
| Regulatory approval | FDA 510(k) clearance for iPredict-DR (K253704) (2026-07-02) | https://fda.innolitics.com/device/K253704, https://www.businesswire.com/news/home/20260708049235/en/iHealthScreen-Receives-U.S.-FDA-510k-Clearance-K253704-for-iPredict-DR-an-AI-Powered-Software-for-Automated-Diabetic-Retinopathy-Screening, https://www.morningstar.com/news/business-wire/20260708049235/ihealthscreen-receives-us-fda-510k-clearance-k253704-for-ipredict-dr-an-ai-powered-software-for-automated-diabetic-retinopathy-screening |
| Certification | CE certification for screening AMD, DR, and Glaucoma (2026-09-01) | https://ihealthscreen.org/investors/executive-summary, https://physicianaitools.com/companies/ihealthscreen/ |
| Regulatory approval | Regulatory approvals in Australia (TGA), UK (MHRA), and UAE (2026-09-01) | https://ihealthscreen.org/investors/executive-summary, https://physicianaitools.com/companies/ihealthscreen/ |
| Revenue | $660,339 annual revenue (2024) (2024-12-31) | https://www.sec.gov/Archives/edgar/data/1968655/000196865525000002/comb_bal_PL_2024.pdf |
| Production site | Richmond Hill, New York (Headquarters); Melbourne, Australia; Abu Dhabi, UAE; Dhaka, Bangladesh | https://www.ihealthscreen.org/contact-us |

Independent sources: businesswire.com, fda.innolitics.com, morningstar.com, physicianaitools.com, sec.gov

## Technologies

- [AI optical coherence tomography screening](https://en.bioecon.ru/technology/ai-optical-coherence-tomography-screening/)