Israeli Medtech First-in-Human Studies Abroad: Caucasus, Central Asia or Latin America

General information, not legal or regulatory advice. Sources checked on 25 October 2026. bioaccess® is not affiliated with any company named on this page, and describes other companies only by what they publish themselves.

What the registry shows

• Magenta Medical: NCT07293923 lists sites in Georgia and Israel.
• Endomatic: NCT06099106 lists a site in Tashkent, Uzbekistan.
• ENTire Medical: NCT06438185 lists sites in Uzbekistan and Israel.
• Sanoculis: studies such as NCT05638321 list a site in Armenia.
• Precise Bio: NCT07325097 lists sites in Armenia and Israel.

We describe these studies only by their public registry entries and draw no conclusion about any company’s choices.

Standards and U.S. data acceptance

The U.S. Food and Drug Administration (FDA) accepts device data from outside the United States under 21 CFR 812.28 when the study follows good clinical practice (GCP), has independent ethics review and informed consent, and FDA can validate the data. The rule is the same whether the sites are in Central Asia, the Caucasus or Latin America.

How Latin America compares

• Same FDA rule: 21 CFR 812.28.
• Published clocks: our Panama hub publishes 3–5 week ethics approval and a 6–8 week average to first patient with bioaccess® coordination; our Brazil hub publishes 6–10 weeks for ANVISA plus ethics review.
• Time zone: 0–2 hours from U.S. Eastern.
• U.S. continuity: bioaccess® is headquartered in Miami; its sister organization Amavita Research Services runs a Miami device and early feasibility study site.
• Trade-offs: Spanish or Portuguese documents and investigational import permits.

More: FIH in Chile · FIH in El Salvador · Uzbekistan · Kazakhstan · Georgia · Armenia · Clinical Accelerator comparison · Vantage Clinical comparison

Frequently asked questions

Where do Israeli device companies run FIH studies abroad?

Public ClinicalTrials.gov records show Israeli sponsors with sites in Georgia, Uzbekistan and Armenia, among others.

Can Latin American FIH data support FDA submissions?

Yes, under 21 CFR 812.28, if GCP is followed and FDA can validate the data.

Next step

Weighing Central Asia or the Caucasus against a Latin American start? Schedule time with Julio G. Martinez-Clark, CEO of bioaccess®, or come on the Global Trial Accelerator podcast to talk through your FIH plan.