AI Algorithm Gets FDA Breakthrough Device Designation
The algorithm, designed to help diagnose pulmonary hypertension earlier, aims to ensure patients get treatment sooner.
The algorithm, designed to help diagnose pulmonary hypertension earlier, aims to ensure patients get treatment sooner.
Counterfeit COVID-19 tests are being illegally imported into the US and being distributed to unsuspecting consumers across the country.
Recall of Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test the latest in string of recent Class I events.
Celltrion’s recall was labeled by the FDA as Class I, due to the kits possibly being distributed to non-CLIA certified users.
The changes affect the Office of Product Evaluation and Quality’s Office of In Vitro Diagnostics and Radiological Health.