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.
A patient, Dena Lawler, is suing Boston Scientific and the US FDA over alleged harm from a spinal stimulator device. Lawler claims inadequate regulatory review allowed dangerous modifications to the device, which then caused her pain and other health issues. She is calling for reconsideration of the device approvals.
Route 92 says it has reached a settlement with Q’Apel Medical over patent claims concerning its Tenzing delivery catheters.
With a projected FDA submission within the next two to three years, Harbinger is prioritizing cancers based on lethality, prevalence, and unmet diagnostic need. Pancreatic and biliary cancers – often diagnosed at late stages and lacking established screening programs – will be among the initial targets.
