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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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.
Exec Chat: Abbott’s Burton Talks About Abbott’s Plans To Address Chronic Pain With SCS
Allen Burton, the medical director of Abbott’s neuromodulation business and a leader in pain medicine, talked to Medtech Insight about the FDA’s new labeling for Abbott’s spinal cord stimulation devices that includes non-surgical back pain.
News We’re Watching: Medtronic To Buy EOFLow, Neuralink Cleared For Human Trials, NICE Backs Genetic Tests
This week, Medtronic said it would pay $738m for insulin patch firm EOFlow; Neuralink got an FDA OK for first-in-human trials; and UK agency NICE backed genetic tests for stroke patients and digital therapeutics for mental health conditions.