Firm submits PMA application to treat medically refractory partial onset epilepsy with its RNS System implant. The device is unique in that it is designed to detect abnormal electrical activity in the brain and then deliver small amounts of electrical stimulation to suppress a seizure before it occurs - referred to as responsive neurostimulation. This "differs from the continuous or intermittent stimulation provided by commercially available neurostimulation systems," the company explains. The privately held firm's 191-patient randomized pivotal U.S. trial showed that the device reduced seizure frequency by 37.9% after three months compared to 17.3% for sham treatment - a statistically significant difference, according to NeuroPace. While Cyberonics' VNS Therapy vagus nerve stimulation implant is currently the only FDA-approved implant for drug refractory epilepsy, Medtronic expects to gain U.S. approval for its DBS deep brain stimulation implant for epilepsy later this year following an FDA panel endorsement in March (1"The Gray Sheet" March 15, 2010)
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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.
Fujirebio Diagnostics' Alzheimer's disease test, Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, has been cleared by the US FDA.
Post-market surveillance regulations for medtech system users in Great Britain coming into force on 16 June will make new data requirements under new compliance deadlines.
The consumer genomics firm will operate as a subsidiary, while Regeneron plans to leverage its database for drug discovery and trial design efforts.
