The company announced the US launch of the AcQCross Qx transseptal dilator/needle. It is specifically designed to help deploy Boston Scientific’s Watchman left-atrial appendage closure device, but it is part of the left-heart access device portfolio that Acutus recently sold to Medtronic.
Acutus is rolling out the AcQCross Qx left-heart access system for use with Boston Scientific’s TruSeal and FXD delivery systems for its Watchman left-atrial appendage closure devices.
In February 2022, the US Food and Drug Administration cleared the latest model of AcQCross Qx as an integrated...
A Japanese study of Watchman LAA closure devices found that leaks of any size after implantation raise the risk of stroke. The study comes shortly after the US FDA issued an early alert for the Watchman access systems.
A late-August batch of device classifications from the US FDA includes genetic tests from 23andMe, hand-held spinal surgery tools, and several IVDs.
Amendments to Germany’s – barely in force – health reform law will be decided after the summer break. The new DRGs payments plan and service groups will be reviewed, but critics fear for the law’s future.
