Disetronic Swiss Facility QS Problems Draw Warning Letter, Import Alert
Roche Diagnostics is working with FDA to resolve quality systems issues uncovered at the Burgdorf, Switzerland facility of recently acquired insulin pump maker Disetronic Medical Systems
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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.
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Dublin-based Neuromod has closed a €10m ($10.9m) series B funding round to bring a "new standard of care" to patients with tinnitus.
If medtech becomes embroiled in the EU-US trade war, access to critical and innovative medical devices will be under threat.
The US FDA is seeing more staff turnover this week, with CDRH deputy director for science Douglas Kelly announcing his departure while the agency gets a new chief counsel and chief of staff.