FDA has conditionally approved a 425-patient trial, called SHIELD II, comparing Thoratec's HeartMate PHP to Abiomed's Impella 2.5. The company expects the study to begin in the third quarter.
Thoratec Corp. expects its SHIELD II trial testing its HeartMate PHP catheter-based heart-pump in patients undergoing high-risk coronary interventions to begin enrolling patients at up to 60 U.S. sites in the third quarter of 2015.
The company announced May 26 that FDA has conditionally approved an investigational device exemption for SHIELD II and expects FDA...
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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.
