The worldwide voluntary removal comes in response to reports that the pin that connects the valve to the delivery system sometimes releases prematurely, most likely due to excess tension created during manufacturing.
Boston Scientific Corp.’s Lotus transcatheter aortic valve business has run into trouble again with the company announcing a voluntary worldwide recall of all Lotus valve devices, including Lotus with Depth Guard, from all commercial and clinical sites.
The company announced Feb. 23 it was removing the devices from the field after receiving reports that the pin that connects the valve to the delivery system may release prematurely....
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.
