June 2023 FDA Watch
So far, it appears many post-PHE COVID-19 tests will be panels for detecting and differentiating among multiple respiratory viruses.
Bill Would Require Medicare to Cover New Breakthrough Devices for at Least 4 Years
The bill is designed to provide Medicare patients faster access to innovative technology approved by the FDA.
FDA Keeps COVID-19 EUA Pipeline Open While Working toward Transition
HHS secretary takes action to ensure that EUAs remain in effect until the “significant potential” for a COVID-19 PHE no longer exists.
What Happens to COVID-19 Tests after the EUA Pipeline Closes Down?
Companies in the COVID-19 diagnostic products market will need to decide whether to wind down their EUA-based investments.
FDA Watch: 2022 510(k) Lab Test Approvals Year in Review
Abbott and Roche garnered the lion’s share of new 510(k) lab test approvals in 2022.