MeMed’s Diagnostics, BV Test and Key Platform Get 510(k) Clearance
MeMed has received 510(k) clearance from the FDA for its MeMed BV test, which is designed to distinguish between bacterial and viral infections.
Rather than focusing on detecting the presence of a microbe, MeMed’s technology analyzes the body’s immune response to infection, an approach that “allows robust diagnosis when the infection site is inaccessible or unknown, even when the pathogen is undetectable using conventional tests or when the cause of infection are emerging new pathogens,” the company said.
The test runs on the MeMed Key immunoassay platform that enables the measurement of multiple proteins without having to send samples to a remote laboratory for analysis. The “point-of-need” test enables better-informed antibiotic treatment decisions, the Haifa, Israel-based company said.