August 2023 FDA Watch
Centers for Medicare & Medicaid Services proposes TCET pathway to expedite Medicare Coverage of newly approved breakthrough devices.
Centers for Medicare & Medicaid Services proposes TCET pathway to expedite Medicare Coverage of newly approved breakthrough devices.
The agency recently announced it will decide in December whether to grant clearance for a CRISPR therapy for treating sickle cell disease.
Abbott and Roche garnered the lion’s share of new 510(k) lab test approvals in 2022.
The test manufacturer is the first to gain IVDR certification for a companion diagnostic under the new regulation.
Here are what G2 Intelligence considers to be the 10 most significant FDA lab testing clearances of 2022, in rough chronological order.