A roundup of the significant new diagnostic tests and products that received regulatory approval in the US and around the world.
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In draft guidance, the FDA is proposing that medical device makers will need to consider how accessible their products are to underserved populations.
The FDA designated 213 submissions as breakthrough devices in 2021, the most awarded in a single year, by far.
On Jan. 11, the FDA warned consumers not to use COVID-19 tests from LuSys Laboratories, as they have not been approved for use in the US.