The orthopedics manufacturer announced in a recent filing that the US Health and Human Services watchdog has asked for a range of records related to health-care consulting arrangements.
Federal investigators are looking at Zimmer Biomet Holdings Inc.’s health-care consulting deals, the orthopedics giant said in an Aug. 8 public filing.
The quarterly filing with the US Securities & Exchange Commission says that the Department of Health & Human Services Office of the Inspector General in June requested “a variety of...
A Texas court's decision against US FDA regulation of lab-developed tests (LDTs) has introduced new uncertainties for clinical labs. Industry stakeholders are now worried about potential future regulations while also managing existing compliance requirements. Recent conference discussions underscored the complexities of FDA oversight.
A study from Babson Diagnostics published in the peer-reviewed Journal of Applied Laboratory Medicine showed that capillary blood sample volume issues can overcome historical challenges, such as poor quality, through a technique called assay miniaturization.
Fujirebio Diagnostics' Alzheimer's disease test, Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, has been cleared by the US FDA.
