The company says Biomonitor III documents suspected arrhythmias or unexplained syncope in patients who have experienced cardiac arrhythmias or who are at risk for cardiac arrhythmias.
Biotronik SE & Co. KG says its new injectable cardiac monitor offers superior signal clarity and battery life to competing systems, which allows physicians to monitor patients for arrhythmias in less time per case and at lower cost.
Biomonitor III, which earned a 510(k) from the US Food and Drug Administration in July, automatically records arrhythmias, including atrial fibrillation, bradyarrhythmia, asystole or a sudden increase or decrease in...
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.
