Firm gains 510(k) clearance for its Jetstream G3 peripheral atherectomy catheter for the treatment of peripheral vascular disease, Pathway announces Jan. 13. G3 features a new distal cutter and enhanced aspiration efficiency, allowing the device to cut and remove disease better than previous versions, the company notes. The new device will be "particularly desirable for long, diffusely diseased segments, including calcifications, chronic total occlusions and traditional 'no stent' zones," according to cardiologist Tom Shimshak, M.D., who is quoted in the company's release. Pathway Medical's G2 catheter launched in February 2009 (1"The Gray Sheet" Feb. 9, 2009)
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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.
