FDA Will Drop “Cycle” Goals, Prioritize Interactive Device Reviews
FDA is proposing to eliminate premarket review interim "cycle" goals in order to prioritize more informal, interactive reviews and final approval decision times under a plan for reauthorization of the medical device user fee program released April 16
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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.
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Though the advance of remote medical device technology allows for better at-home care, it comes with challenges and risks, says AdvaMed, which has published a safety bulletin guiding stakeholders on the operation of remote devices.
Partnership, positive communication and passion were all key in establishing a regulatory route for groundbreaking genetic testing technology for hereditary diseases. So said Fulgent Genetics’ executives interviewed by MTI about their technology’s development pathway.
Fresh off de novo clearance, Biolinq plans to launch its needle-free CGM for type 2 diabetes not on insulin in early 2026. Pricing has not been disclosed, but “won’t be too far apart” over rivals Abbott’s Lingo and Dexcom’s Stelo CGMs, CEO Rich Yang said.