An FDA advisory panel recommended a collection of activities to mitigate risk in the use of Bayer Healthcare’s Essure permanent contraceptive device, but dozens of patients describing hypersensitivity, extreme pain, insert migration, irregular bleeding, ectopic pregnancy and perforation events urged FDA to recall the device.
More information about risks linked to Bayer HealthCare LLC ’s Essure permanent female sterilization device and about potential removal of the device needs to be provided to patients and physicians, FDA advisors said Sept. 24.
The agency's Obstetrics and Gynecology Device Advisory Panel met at FDA's Silver Spring, Md., headquarters, to consider implications of 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.
The Development Bank of Wales and London-based Parkwalk Advisors led an investment round of £5m, almost doubling Ceryx Medical's total investment to date.
SS Innovations reported its first SSi Mantra 3 robotic cardiac surgery in South America as it prepares to file for US FDA de novo clearance and a CE mark. The firm aims to challenge Intuitive Surgical with a lower-cost, flexible system targeting US and European markets.
Innovative Healthcare is asking for a permanent injunction against Johnson & Johnson subsidiary Biosense Webster after winning a $442 million antitrust verdict. The injunction aims to prevent continued anticompetitive practices in the electrophysiology catheter market.
