Endovascular device maker launches second-generation Jetstream G2 peripheral atherectomy catheter for removing plaque, calcium buildup, thrombus and fibrotic lesions in lower limb arteries after receiving 510(k) clearance Feb. 2. Peripheral artery disease affects around 12 million Americans and is associated with high blood pressure, diabetes, heart disease, stroke and aging, the firm says. Jetstream G2's design enhancements over the first-generation Jetstream, which received FDA clearance in September 2008, include an aspiration port that is separate from the cutting mechanism to provide greater aspiration efficiency and a masticating system located within the port to help break aspirated material into smaller pieces before removal, the firm explains
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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.
While HistoSonics is awaiting the CE mark in Europe, it hit a major milestone by securing early limited market access in Great Britain under a Unmet Clinical Need Authorization (UCNA), bringing its noninvasive histotripsy treatment to patients with liver tumors.
Manufacturing shifts, financial planning, and supply chain changes are among the adjustments that medtech leaders are making to Trump-era tariffs. Medtech Insight’s review of first-quarter earnings calls reveals how firms are navigating the impact and uncertainty of evolving trade policies.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Thirty-six documents have been posted on the tracker since its last update.
