With recent test recalls announced by Universal Medtech and QuidelOrtho, such products now make up one-third of 2023 total recalls listed by the FDA.
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.