Investigational device exemption (IDE) applications for knee cartilage replacement products should include a detailed product description, manufacturing and packaging methodology, and nonclinical testing data to assess biological responses and toxicology, FDA advises in a July 9 1draft guidance
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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.
There is still no clarity on how life sciences will be treated in the final agreement.
NICE’s three-pronged lifecycle approach to healthtech evaluations includes late-stage assessments (LSA), which will be the focus of a short consultation in August.
Roche has taken steps to mitigate potential tariff exposure that include shifting inventories and increasing US production of medicines. The company also initiated a tech transfer for one of its most exposed products to a US manufacturing site.
