Boston Scientific plans to increase its stake in the vagus nerve stimulation (VNS) technology firm from nearly 15% to up to 20% of outstanding shares, after a Dec. 10 shareholder rights plan amendment clears the way. Signaling the potential for broader ties down the road, the move follows a roughly $50 mil. Boston Scientific investment earlier this year (1"The Gray Sheet" June 16, 2003, In Brief). Cyberonics, which holds FDA approval for adjunctive, drug-resistant epilepsy treatment, simultaneously announced the agency accepted for filing its October PMA supplement submission for adjunctive, drug-resistant depression treatment Dec. 9 (2"The Gray Sheet" Nov. 10, 2003, In Brief). Cyberonics has projected potential depression sales of over $1 bil. by 2010...
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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 EU is testing a groundbreaking “all-in-one” process for reviewing combined drug and diagnostic trials via a single application for coordinated assessment.
EU countermeasures against US tariffs suggest medtech categories exported to the EU could be targeted for tariffs. MedTech Europe and the German IVDs industry have stressed the negative effects this would have on patient care.
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.
