First genetic test for warfarin sensitivity cleared: Nanosphere's Verigene multiplex nucleic acid test for genetic variations that influence metabolism of the common blood-thinner warfarin is 510(k)-cleared Sept. 17. FDA updated the labeling of warfarin in August to explain that patients with variations in the CYP2C9 and VKORC1 genes may respond differently to the drug (1"The Gray Sheet" Aug. 20, 2007, p. 9). Other firms developing warfarin test kits include AutoGenomics, Nanogen, Third Wave Technologies and Luminex
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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.
2026 reimbursement calculations for the list of hybrid DRGs – a mechanism to incentivize day cases over inpatient surgery – will be issued in few weeks’ time. The medtech industry has made its demands known.
An interactive look at medtech and diagnostics deals made during July 2025. Data courtesy of Biomedtracker.
The FDA's Device Clinical Trial Snapshot Pilot, aimed at increasing trial transparency and diversity, has been canceled following President Trump’s anti-DEI executive order. Critics warn this may hinder trial transparency, impacting public health and demographic data accessibility.
