Despite failing to move on a bill to restrict FDA oversight of lab developed tests (LDT) or reintroducing the bill in recent sessions, Rep. Michael Burgess, R-Texas, says he still supports the idea and is still working on trying to limit the agency's authority.
A top Republican on the House Energy and Commerce Committee says he is still considering legislation to limit FDA from regulating laboratory developed tests (LDT).
Speaking at the Personalized Medicine Coalition (PMC) annual luncheon on April 15 at the National Press Club, Rep. Michael Burgess,...
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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.
A Japanese study of Watchman LAA closure devices found that leaks of any size after implantation raise the risk of stroke. The study comes shortly after the US FDA issued an early alert for the Watchman access systems.
A late-August batch of device classifications from the US FDA includes genetic tests from 23andMe, hand-held spinal surgery tools, and several IVDs.
Amendments to Germany’s – barely in force – health reform law will be decided after the summer break. The new DRGs payments plan and service groups will be reviewed, but critics fear for the law’s future.
