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  • Regulatory NewsRegulatory News

    Vagal nerve stimulator for stroke rehab nabs FDA nod

    The first-ever vagal nerve stimulation system for chronic ischemic stroke rehabilitation has received approval through the US Food and Drug Administration’s (FDA’s) most stringent pathway.   The vagal nerve stimulation (VNS) system will be marketed by MicroTransponder as the Vivistim Paired VNS System. The device enters the market through FDA’s premarket approval pathway after receiving breakthrough device designation.   "People who have lost mobility in their hand...
  • Boehringer Ingelheim's Blot Clot Drug Cleared for NHS Use

    The UK's National Institutes of Health and Clinical Excellence (NICE), the country's cost containment agency, has cleared the use of Boehringer Ingelheim's alteplase (Actilyse) for the treatment of acute ischaemic stroke by the National Health Service (NHS) in  final guidance  issued on 26 September.   The guidance recommends starting treatment as early as possible within 4.5 hours after onset of stroke symptoms, and after intracranial haemorrhage has...