OMB Program Assessment Tool Benefits Medical Device Review Reduction
FDA's revised target for medical device review times would yield a nearly 10% reduction in total FDA days for half the premarket applications approved between fiscal 2005 and 2007
More from Archive
Editor’s note: This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.
Editor’s note: We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, content format or the method in which you receive and access Medtech Insight, or if you love it how it is, now is the time to have your voice heard.
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.
More from Medtech Insight
As AI tools make research fraud and résumé fraud easier than ever, life sciences companies need to take steps to protect themselves. Snedden Campbell CEO Ivor Campbell has some tips on successful strategies.
The timing aligns with Medtronic’s plan to spin off its $2.8bn diabetes unit, now named MiniMed. As a standalone entity, MiniMed will be more responsive to competition, regulatory shifts, and the diabetes technology needs of healthcare systems.
The EU’s extra layer of checks on clinical evidence is proving a difficult, and sometimes humiliating process, for many device companies whose products have come under the spotlight.