THE FIRST QUALITY-RELATED DEVICE 'CLOSE-OUT' LETTER was sent by FDA to manufacturer Z-Medica on March 1, officially closing out a December 2009 warning letter that cited the firm for four violations of the Quality System Regulation. Z-Medica's close-out letter came surprisingly fast, given initial expectations from CDRH's Office of Compliance that close-outs could take up to a year. How quickly future close-out letters are issued depends on the specific violations and whether a follow-up inspection is needed, said Larry Spears, deputy director of regulatory affairs in the compliance office. Attorneys debate whether Z-Medica deserved the close-out letter and whether the contents were sufficient. Z-Medica explains how it fixed its quality problems and gained resolution with FDA in less than five months
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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.
Broad participation by EU member states in a new pilot to test a unified procedure for evaluating applications for combined drug and IVD studies shows they recognize its value, says Monique Al, vice-chair of the Clinical Trials Coordination Group.
MedTech Europe is ready to become involved and shape Europe’s Life Sciences Strategy and help drive regulatory simplification from the top to make the EU “the world’s most attractive place for life sciences by 2030.”
The UK government’s blueprint to deliver an NHS "fit for the future" was released on July 3.
