MDR coding revamp: CDRH has a new 1Web site to help companies understand the new Medical Device Reporting (MDR) coding system that goes live July 1, marking the system's first redesign since its inception. FDA is addressing limitations of the current system, which has undefined or ambiguous codes, no formal process to request new codes and no hierarchical structure (2"The Gray Sheet" March 3, 2008, p. 9). Come July 1, the new codes can be used in Form 3500A mandatory adverse event reports, as well as any other device-related event reporting, such as clinical study and patient safety reporting. FDA anticipates it will stop accepting the old codes by April 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.
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.
