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.
European venture capital firm Sofinnova Partners’ portfolio companies BioCorteX, Bioptimus, Cure51 and Latent Labs will benefit from the investor’s new partnership with tech giant NVIDIA.
Preparations for the reauthorization of the Medical Device User Fee Amendments for 2028-2032 are underway, with the US FDA announcing a public meeting for 4 August. After negotiations with industry and other stakeholders, a draft agreement is due to Congress by 15 January 2025.
Robert Foster, HHS deputy general counsel and chief counsel for food, research and drugs, is temporarily heading the Office of Chief Counsel, but a permanent appointee is expected after Michael Stuart's confirmation as HHS general counsel.
