MedMira's rapid HIV tests edges closer to the US:
This article was originally published in Clinica
Executive Summary
MedMira's Reveal Rapid HIV test is to enter the final leg of the US pre-market approval (PMA) process, after the company received notification of the date for a comprehensive pre-approval inspection by the FDA. If the inspection is successful, the three-minute Reveal test "would be the only such device with PMA approval in the US", said Stephen Sham, the Toronto, Ontario firm's chairman and CEO. MedMira noted that its US distributor, American Health Diagnostics, has already placed an initial order for 500,000 Reveal test kits to be shipped pending receipt of the PMA.