Firm notes that it has not yet heard from FDA on whether an advisory committee review will be required for its left ventricular assist device, intended as a bridge to transplant.
HeartWare International Inc. is aiming for PMA approval of its first left ventricular assist device by later this year, the company told analysts during a Jan. 9 session of the JP Morgan Healthcare Conference in San Francisco.
HeartWare had previously anticipated an FDA advisory panel review of its flagship HVAD pump by the end of 2011, and...
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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.
A surgeon at Ochsner Health in New Orleans was able to successfully remove a rare and dangerous tumor from a patient’s spine using cutting-edge technology that would have otherwise made the procedure too risky.
An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.
The FDA's new Commissioner’s National Priority Voucher program aims to expedite drug approvals significantly. Device firms like XVIVO advocate for a similar initiative for devices, emphasizing the potential for faster reviews and improved patient access to lifesaving technologies.
