Biotronik Begins US Rollout Of PK Papyrus For Coronary Perforations
Executive Summary
The US FDA granted PK Papyrus a humanitarian device exemption (HDE) in late 2018, the first FDA approval of a device to treat coronary perforations since Abbott's Jomed Jostent earned an HDE in 2001.
You may also be interested in...
Biotronik Rolls Out Biomonitor III Injectable Cardiac Monitor
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.
AMA Establishes Principles For ‘Augmented Intelligence’
The American Medical Association has written a set of principles for augmented intelligence (AI) development and deployment in health care. The organization hopes these principles can shape “a consistent governance structure for advancements in health care technology.”
News We’re Watching: Boston Scientific Closes Relievant, Medtronic's PFA Earns CE Mark, And More
Medtech Insight's News We're Watching highlights medtech industry news developments you may have missed over the last few weeks.