TruScreen's cervical cancer screening technology has been certified for use in Mexico.
The government certification means TruScreen's device can be sold to government hospitals and public entities, and be marketed and promoted to the general public in Mexico.
TruScreen chief executive Martin Dillon said the Mexican market was strategically significant for the company's growth plans in the broader Latin American region.
With 30 million Mexican women of screening age, he estimated the potential market at $100 million a year.
"Our next step now is to build from these approvals to penetrate into those government hospitals and government programmes in Mexico," he said.
The company has also been given permission to market its technology in China.