Medtronic's third recall of some hemodialysis catheters, data backs Nevro's spinal cord stim - podcast episode cover

Medtronic's third recall of some hemodialysis catheters, data backs Nevro's spinal cord stim

Aug 17, 202310 min
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Episode description

CathVision this week announced the FDA clearance of its PVI Analyzer and Signal Complexity algorithms for facilitating electrogram interpretation. The regulatory nod makes these artificial intelligence-based tools available to physicians. Fast Five hosts Sean Whooley and Danielle Kirsh explain what the algorithms are used for and what sets them apart from traditional EP recording systems. AngioDynamics received FDA breakthrough designation for its AngioVac system. The designation includes proposed indications for the use of AngioVac in the non-surgical removal of vegetation from the right heart. Find out what the company plans to do with the breakthrough nod and what executives see for the future of AngioVac. Tivic Health is planning to begin its vagus nerve stimulation trial after receiving Institutional Review Board (IRB) approval. Whooley shares details of the study, what the IRB approval means for Tivic and what the company hopes to achieve in the study. New data from a two-year trial of Nevro's spinal cord stimulation trial demonstrated durable pain relief and significant improvements in health-related quality of life. Learn some of the data points from the study and what doctors think about the results of the trial in today's episode. Medtronic's Mahurkar hemodialysis catheters are facing their third Class I recall. More than a million Mahurkar catheters have been recalled since July 2022. Whooley and Kirsh share the issue in this recall and how many devices are affected. Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast.
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Medtronic's third recall of some hemodialysis catheters, data backs Nevro's spinal cord stim | Fast Five Medtech News Podcast - Listen or read transcript on Metacast