Diagnostics Regulatory News

The latest headlines on diagnostics regulation: FDA, CMS, and international regulatory agencies.

New Medicare rates established under PAMA will cause labs to scale back services, and in some cases shut down, the motion states.

The Class III Medical Device System License enables an early-risk assessment of the most common fetal genetic abnormalities in the first trimester of pregnancy.

The test from Banyan Biomarkers called the Brain Trauma Indicator measures the levels of the proteins UCH-L1 and GFAP that are released into the blood.

The immunoassay allows for the rapid detection of influenza types A and B antigens directly in nasal swab and nasopharyngeal swab specimens from symptomatic patients.

The test runs on the BD Viper LT system and detects 14 high-risk types of human papilloma virus.