FDA Authorizes PJI Test

In a news release issued last week, the U.S. Food & Drug Administration announced marketing authorization of the Synovasure Lateral Flow Test Kit to CD Diagnostics Inc. The test will allow surgeons to detect “periprosthetic joint infection (infection around a joint replacement) [PJI] in the synovial (lubricant) fluid of patients being evaluated for revision surgery,” according to the release. While the test will determine whether infection is present, it does not identify the type of infection. This is the first FDA authorization of a diagnostic test for joint infection. Full story.