The US Food and Drug Administration's user fees for individual device submissions will increase by about 4% beginning October 1, and the annual registration fee will rise by 5.5% in FY 20161.
The US Food and Drug Administration's user fees for individual device submissions will increase by about 4% beginning October 1, and the annual registration fee will rise by 5.5% in FY 20161.
This is a switch from last year when rates for individual submission fees actually declined in FY 2015 compared to...
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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.
Faction Imaging has come out of stealth mode following six years of research and development studying medical imaging workflows in India, Japan and the US.
Remepy is exploring two potential regulatory pathways to support this strategy. The first is a combination product pathway that would formally integrate software and drug into a single therapeutic entity. The second is the FDA’s Prescription Drug Use-Related Software (PDURS) pathway.
An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.
