Center for Devices and Radiological Health director's office and office of compliance and surveillance enforcement divisions tentatively are scheduled to move from current facilities at 1390 Piccard Drive to new offices at 2094 Gaither Road in Rockville, Maryland in early July. The new building also is expected to house some staffers from the center's office of training and assistance. OCS' administrative and bioresearch monitoring divisions are set to move to an adjacent site at 2098 Gaither Road by early August.
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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 study from Babson Diagnostics published in the peer-reviewed Journal of Applied Laboratory Medicine showed that capillary blood sample volume issues can overcome historical challenges, such as poor quality, through a technique called assay miniaturization.
The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.
Moves are at last underway for a more specific focus on orphan and pediatric devices. They are a start; but experts are calling for more to support this sector.
