CME America Announces a Follow-Up on the Voluntary Recall of BodyGuard® Infusion System Administration Sets
As part of CME America's commitment to quality, following the previously announced recall (April 27, 2020) of the BodyGuard® Infusion Pump Systems, the company conducted additional flow-rate accuracy testing. This testing revealed that some infusion sets do not meet the ±5% delivery accuracy for the system or the ±13% accuracy identified in the earlier recall notification. Therefore, the use of the pump system potentially could cause over-infusion or under-infusion of therapy and patient harm.
Elucid Bio: Study Demonstrates that AI Technology is Better Predictor of Stroke than Traditional Methods
The study, led by Dr. Brajesh Lal, Director of both the University of Maryland’s Center for Vascular Diagnostics and the NIH Vascular Imaging Core Facility, with participation by the Cleveland Clinic, Weill-Cornell, and Case Western, sought to improve prediction of Major Adverse Neurological Events (MANE; stroke, transient ischemic attack, and amaurosis fugax) by applying AI to traditional carotid imaging using the Elucid Bio vascuCAP software.
LuViva Advanced Cervical Span Awarded New CE Mark with Expanded Claims
The new CE Mark includes expanded claims for the use of LuViva by physicians for the early detection of cervical cancer.
BIOMODEX: Results of First Clinical Study Using Patient-Specific Brain Aneurysm Models for Pre-Procedural Rehearsals
Published in the Journal of NeuroInterventional Surgery (JNIS) this month, the findings demonstrates how use of the 3D printed aneurysm models for pre-procedural rehearsal allows physicians to rehearse for procedures more accurately and reliably.
Michael Enxing joins PainTEQ Board of Directors
With nearly three decades of executive experience, Enxing provides commercial know-how and strategic insight for medical device businesses.