FDA Greenlights More Emergency Devices for Ongoing COVID Fight
Published Date: 1/21/2026
Notice
Summary
The FDA just gave the green light for certain medical devices to be used during the COVID-19 emergency. This means doctors and hospitals can use these devices faster to help fight the virus, keeping everyone safer. These authorizations started as soon as they were issued, making sure help arrives right when it’s needed most.
Analyzed Economic Effects
2 provisions identified: 2 benefits, 0 costs, 0 mixed.
EUA reissue for LumiraDx antigen test
The FDA re‑issued an Emergency Use Authorization for the LumiraDx SARS‑CoV‑2 Ag Test on June 10, 2025, allowing its emergency use to diagnose COVID‑19. The notice says the authorization is effective on its date of issuance and that FDA concluded the test may be effective for diagnosing COVID‑19 and that no adequate, approved, and available alternative exists.
EUAs for multianalyte COVID/Flu tests
The FDA authorized multianalyte tests that detect SARS‑CoV‑2 and influenza A/B: Aptitude Medical Systems Inc.'s Metrix COVID/Flu Test was issued on February 21, 2025, and Healgen Scientific LLC's Healgen COVID‑19/Flu A&B Ag Combo Rapid Test Cassette (Swab) was issued on June 10, 2024. These EUAs say the tests may be effective for simultaneous detection and differentiation of SARS‑CoV‑2 and influenza and are effective on their issuance dates.
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