Ona Health
PRE-CLEARANCE MEDICAL DEVICE CANDIDATE

Diagnostic equity at the edge.

Edge-first AI medical imaging built for primary care. Designed for the communities specialist coverage doesn't reach.

Built for the field

Offline-capable

Models run on device. No internet required for clinical inference. Ensures continuous care in remote or infrastructure-poor environments.

Independent benchmark methodology

Performance assessed using independent clinical data not used in model development. Methodology and detailed results shared with qualified partners under NDA.

Designed for non-specialists

Built for technologists and primary-care providers. Multi-language support planned (English and Swahili). Minimal training required.

Regulatory pathway
Quality framework
External validation
U.S.-incorporated
Mission-driven

“I started Ona because the gap between where medical AI exists and where it's needed is unacceptable. The communities with the fewest specialists are the ones AI imaging hasn't reached — and the architectures that work in tier-1 hospitals don't fit primary care in resource-constrained settings.

We're building edge-first AI imaging for the clinics that current technology has skipped. Pre-revenue. Pre-clearance. Building deliberately, in the open, with the right partners.

If your work touches diagnostic equity, primary care, or underserved populations — let's talk.”

— Keyse Arre, Founder

Partner with us in the build.

We are pre-revenue and pre-clearance. Our commitment is to clinical integrity and architectural transparency. If your work aligns with diagnostic equity for primary care — we want to talk.