Medtronic says it reached the necessary trial enrollment to support PMA approval for its IN.PACT Admiral drug-eluting balloon catheter to treat atherosclerosis in the superficial femoral artery. On the same day, CR Bard said it was prepared to submit its final PMA module for its Lutonix drug-eluting balloon by year’s end.
Medtronic PLC and CR Bard Inc. appear to be in a close race to become the first to market a drug-eluting balloon catheter in the U.S. Both firms announced major milestones this week for pivotal trials of their drug-eluting balloons targeting the peripheral arteries.
Medtronic said June 3 it has enrolled more than 1,000 patients in clinical studies of its IN.PACT Admiral paclitaxel-eluting balloon. The firm says those patients will provide enough data to...
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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.
An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.
TRiCares presented data from the first-in-human study for its tricuspid valve replacement system – Topaz – at EuroPCR 2025 on 22 May.
The US’ 90-day suspension of higher “reciprocal tariffs” will expire on 9 July, raising fears that the 31% tariff rate on Swiss medtech and other goods exported to the US might make a comeback. While the tariff situation changes on an almost daily basis, medtechs should forearm for any eventually, say local business organizations.
