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Tethys Builds A Case For Pre-Diabetes Algorithm-Based Screening
Diagnostics start-up Tethys Bioscience is laying the groundwork for its first product - a lab test it says will improve screening of the more than 50 million people at near-term risk for developing type-2 diabetes and help identify the best candidates for early-stage intervention
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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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Terumo will acquire OrganOx for about $1.5bn, adding the only FDA-cleared liver normothermic perfusion device to its portfolio. Analysts don’t expect the buyout to have a significant impact on competition, but the deal marks a strategic shift for Terumo into transplant medicine.
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A Johns Hopkins University study found publicly traded companies are responsible for 90% of recalled AI-powered medical devices. The study attributes this link to lower clinical validation, especially among smaller companies, and advocates for increased clinical trials to enhance device safety.
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Medicare’s device coverage process is “a system in crisis,” consultant Bruce Quinn warned at the NextGen Dx Summit. He criticized bloated NCDs, stalled advisory committees, and years-long delays, urging CMS to streamline LCDs and adopt a six-month “fast-track” model to speed innovation access.