Medtronic gets temporary pacemaker approval:
This article was originally published in Clinica
Executive Summary
Medtronic's (US) model 5348 single chamber temporary pacemaker was been cleared by the US FDA in time for it to go on display at the AHA meeting. The simple 9 V device also features atrial arrhythmia management and can store sufficient energy to maintain pacing while its battery is changed.
You may also be interested in...
New OSP Director To Guide CDER-Wide IT Upgrades; System Enhancements Speed ANDA Assessments
Generic Drug Structured Assessment for Bioequivalence launched in 2023 and has been used in 40 ANDA reviews so far.
New EU Approvals
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add two new products, including Ryzneuta, Evive Biotechnology's treatment for chemotherapy-induced neutropenia.
Pair Of Deaths Linked To Recalled Vyaire Medical Respiratory Devices
The US FDA has labelled a recall of more than 6 million Airlife respiratory support devices class I. The recall covers devices manufactured in 2017 or earlier that can fail to provide adequate ventilation.