Modular PMA Guidance Issued As Program’s Premarket Approval Yield Grows

FDA's new guidance on modular premarket approval applications includes measures designed to ensure ample time for reviewers to evaluate the submissions

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Patients With Movement Disorders Will Benefit From Medtronic’s Expanded MRI Labeling For DBS

 
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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.

Podcast: Lung Life AI CEO Shares Regulatory And Reimbursement Journey For Lung Cancer Diagnostic

 

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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Under Pressure: How To Safeguard The EU Responsible Person

 

The roles and responsibilities of EU medtech’s persons responsible for regulatory compliance vary widely in role and risk exposure. The recent TEAM-PRRC meeting highlighted how vulnerable they can be and the steps to protect themselves.

Viome’s CEO To Expand Into Clinical Diagnostics ‘For Which There Are No Solutions’ With AI, RNA Test

 
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Viome Life Sciences accelerates its push into clinical diagnostics with studies in colorectal cancer and a major partnership with Microsoft to scale its molecular data analysis platform. Viome leverages RNA analysis and AI to detect disease at the molecular level and personalize preventive health.

Philips Ramps Up US Production, Seeks To Swiftly Move On From New FDA Warning Letter

 
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Philips puts its latest “disappointing” warning letter into context, while announcing progress in regulatory performance, expanded US production and tariff resilience plans