Edwards Lifesciences is on track to earn an expanded indication for its Sapien 3 transcatheter aortic valve replacement (TAVR) system – possibly earlier than expected – as the Sapien 3 observational study shows that patients deemed to be at intermediate risk for surgical complications may have better one-year outcomes with the TAVR system than surgical valve replacement.
Edwards Lifesciences is on track to earn an expanded indication for its Sapien 3 transcatheter aortic valve replacement (TAVR) system – possibly earlier than expected – as the Sapien 3 observational study shows that patients deemed to be at intermediate risk for surgical complications may have better one-year outcomes with the TAVR system than surgical valve replacement.
Vinod Thourani of Emory University in Atlanta presented these results of the Sapien 3 observational study April 3 at the...
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Medtronic announced it received expanded MRI labeling for its DBS systems, which is critical, given that almost 70% of all DBS-eligible patients will likely need an MRI at some point in their care, says Ashwini Sharan, CMO for Medtronic Neuromodulation.
In this episode, Medtech Insight reporter Natasha Barrow speaks to LungLife AI CEO Paul Pagano. Lung Life AI is a US-based AIM-listed medical technology company that has developed a liquid biopsy test for the early detection of lung cancer called Lung LB. Pagano runs through the highlights of Lung Life AI journey to date and its future ambition for a strategic partnership. He also provides advice to similar diagnostic companies seeking reimbursement andcompliance with the US FDA Lab Developed Test ruling.
Openwater is currently focusing on EMS applications of its AI-powered stroke detection technology, both in-hospital and prehospital, such as in ambulances and urgent care centers.
Tala Fakhouri said the agency’s use of the AI tool in the review process has generated lots of questions.
Ahead of the ADA conference, Abbott announced Tandem as the fourth partner to integrate Abbott’s dual glucose-ketone sensor with automated insulin delivery. Expanded Medicare CGM coverage, FDA label expansions and new ADA guidelines position Abbott to grow its CGM footprint in a competitive market.
