Clot removal device gains 510(k) clearance earlier than expected, will compete with Stryker’s Merci clot retrieval system.
Medtronic Minimally Invasive Therapies will launch its SolitaireFR revascularization device for acute ischemic strokes in the U.S. next month following receipt of 510(k) clearance, the firm announced March 5.
The FDA clearance comes several weeks earlier than expected. During the firm’s Jan. 26 first-quarter earnings call, the device maker...
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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.
After receiving FDA clearance for its Genio sleep apnea implant, Nyxoah plans a major US rollout despite a patent suit from rival Inspire Medical. Genio offers bilateral nerve stimulation as a CPAP alternative, with strong trial results.
Draeger Medical has recalled certain SafeStar and TwinStar ventilation filters after reports of serious injuries caused by misleading carbon dioxide readings.
The UK device regulator wants to align health institution device exemptions with its evolving policy of agile regulation of medtech in the British market. It asks stakeholders to complete a survey by Sept. 15.
