Investigational Device Exemption

An IDE must be submitted for devices that are considered significant risk prior to beginning clinical trials.

BNP tests Reducing the time to treatment for patients with heart failure

HPV Tests Helping to allay women's fears about a life-threatening disease

Molecular Diagnostics for Influenza Making point-of-care diagnosis possible

Rapid Influenza Detection Tests Helping doctors decide who needs antivirals, and who needs chicken soup