The United Kingdom's National Institute for Health and Clinical Excellence denies Johnson & Johnson/Cordis' appeal of its Feb. 1 recommendation that the National Health Service only cover drug-eluting coronary stents if the device costs no more than £300 ($597) more than a comparable bare-metal stent (1"The Gray Sheet" Feb. 4, 2008, p. 10). 2In a decision released July 23, NICE's appeals panel, which met in April, discounts Cordis' arguments, concluding that NICE's recommendation does not exceed its legal powers or violate its established procedures and is consistent with the scientific evidence. There is no possibility of further appeal within NICE, but interested parties can seek permission form the High Court to apply for judicial review within three months, the panel writes. The denial of the appeal coincides with NICE's re-release of its 3final guidance on drug-eluting coronary stents outlining its recommendations
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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.
During MD&M East last week, regulatory consultant Darren Reeves reminded device manufacturers that the time to get ready to comply with the new Quality Management System Regulation is now.
Handheld diagnostics are more powerful, accessible and clinically relevant than ever. Medtech Insight spoke to companies behind such technologies to learn how they work and discuss their commercial models.
An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.
