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Guidant/EVT Lesson Learned: Post Senior Compliance Execs To Acquired Unit
Integration of a parent firm's adverse event reporting and compliance structure into a subsidiary should begin immediately upon acquisition, as illustrated by Guidant's experience with Menlo Park, Calif. unit Endovascular Technologies
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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.
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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.
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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.
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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.