Edwards Lifesciences' Sapien 3 transcatheter aortic heart valve is now labeled in Europe for use in patients who face an intermediate risk from open-heart surgery, matching a recent US development. Meanwhile, Boston Scientific's next-generation Lotus Edge TAVR device gained a CE mark.
Medical device giants Edwards Lifesciences Corp. and Boston Scientific Corp. have obtained new CE marks on their transcatheter aortic valve replacement (TAVR) products, the companies announced at the ongoing Paris Course of Revascularization (PCR) London Valves meeting in London.
Edwards’ Sapien 3 valve has been granted a CE mark to use the device in patients suffering from severe, symptomatic aortic stenosis who are at intermediate risk for open-heart surgery....
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.
