Considering aCROss Medical? How Georgia and Armenia Compare with Latin America for Device First-in-Human Studies

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

What aCROss Medical says about itself

According to its own website, aCROss Medical is based in Tbilisi, Georgia, and supports clinical studies in Georgia, Armenia, Israel and Uzbekistan. Its site publishes testimonials from device companies including PATH EX, CorNeat Vision, BrainsGate and BioGenCell. We make no claims about its services beyond what it publishes.

The country question

On ClinicalTrials.gov (pulled 25 October 2026), 52 industry-sponsored studies with a 2021-or-later start list a site in Armenia. See our Georgia and Armenia guides for the regulatory paths.

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

Is bioaccess affiliated with aCROss Medical?

No. bioaccess® is not affiliated with aCROss Medical.

Will the FDA accept data from Georgia, Armenia or Latin America?

It can, under 21 CFR 812.28, case by case.

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.