Biotronik Begins US Rollout Of PK Papyrus For Coronary Perforations
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.
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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.
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.”
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