FDA will publicly announce actions it will take on Bayer’s Essure permanent birth control device at the end of February 2016 following its full review of the medical literature, adverse events reports, and input received during and after a September 24 advisory panel meeting on Essure, the agency said in a posting on its website.
FDA says it plans to announce the outcome of its evidence review of Bayer HealthCare LLC’sEssure permanent birth control device at the end of February 2016.
The device, which has been the subject of more than 5,000 adverse event reports, was the subject of a Sept....
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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.
