Nine people have died from bacterial meningitis linked to cochlear implants, the FDA has warned. At least 25 cases of the disease have been diagnosed worldwide in children and adults ranging in age from 21 months to 63 years, the agency said in its first ever "Web Notification" designed to disseminate information quickly.
Nine people have died from bacterial meningitis linked to cochlear implants, the FDA has warned. At least 25 cases of the disease have been diagnosed worldwide in children and adults ranging in age from 21 months to 63 years, the agency said in its first ever "Web Notification" designed to disseminate information quickly.
So far, two out of three manufacturers have reported cases of bacterial meningitis and surveys of cochlear implant centres suggest...
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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.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 50 documents have been posted on the tracker since its last update.
Finland has initiated a project to improve the effectiveness of the monitoring of software intended for medical use and to ensure that software placed on its market meets the requirements set for it.
The Milner Institute, the on-campus hub for start-up acceleration at Cambridge University, hosted its annual Pitch Day on July 1. Start-ups Panakeia, PathwayBio and Sentinal4D presented diagnostic technologies.
