Aptitude Medical Systems

Stories

FDA grants Aptitude first 510(k) clearance for next-gen Metrix COVID test

As of September 2026: First 510(k) clearance for Metrix COVID test; expanding to other assays

The FDA granted Aptitude Medical Systems its first 510(k) clearance for the next-generation Metrix COVID test, a handheld molecular diagnostic for at-home and clinic use. The test delivers roughly three times the analytical sensitivity of the original emergency-authorized version and returns results 30% faster.

Updated Sep 18