# iHealthScreen

近期获得 FDA 510(k) 批准（K253704），用于其 AI 驱动的自动化糖尿病视网膜病变筛查软件 iPredict DR。

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

- 国家: United States

## 可核验事实

| 事实 | 数值 | 来源 |
| --- | --- | --- |
| 融资 | $345万 (2026-05-13) | https://ihealthscreen.org/investors/executive-summary, https://physicianaitools.com/companies/ihealthscreen/ |
| 监管批准 | iPredict-DR获得FDA 510(k)许可（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 |
| 认证 | 获CE认证用于筛查老年性黄斑变性（AMD）、糖尿病视网膜病变（DR）和青光眼 (2026-09-01) | https://ihealthscreen.org/investors/executive-summary, https://physicianaitools.com/companies/ihealthscreen/ |
| 监管批准 | 在澳大利亚（TGA）、英国（MHRA）和阿联酋获得监管批准 (2026-09-01) | https://ihealthscreen.org/investors/executive-summary, https://physicianaitools.com/companies/ihealthscreen/ |
| 营收 | 年营收$660,339（2024年） (2024-12-31) | https://www.sec.gov/Archives/edgar/data/1968655/000196865525000002/comb_bal_PL_2024.pdf |
| 生产基地 | 纽约Richmond Hill(总部);澳大利亚Melbourne;阿联酋Abu Dhabi;孟加拉国Dhaka | https://www.ihealthscreen.org/contact-us |

独立来源: businesswire.com, fda.innolitics.com, morningstar.com, physicianaitools.com, sec.gov

## 技术

- [AI 光学相干断层扫描筛查](https://cn.bioecon.ru/technology/ai-optical-coherence-tomography-screening/)