While standard neurostimulators are open-loop systems that stimulate continuously or intermittently according to preprogramming, RNS is a more targeted, closed-loop system that monitors brain activity in real time and provides electrical stimulation to interrupt troubling patterns that might cause a seizure.
FDA approved NeuroPace Inc.’s RNS neurostimulator system Nov. 14 for drug-refractory epilepsy. It is the first responsive neurostimulator device approved by the agency, intended to detect abnormal brain activity and normalize it before a patient experiences a seizure.
While standard neurostimulators are open-loop systems that stimulate continuously or intermittently according to preprogramming, RNS is a more targeted, closed-loop...
Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
The EU product information for Novo Nordisk’s semaglutide medicines is to be updated to include non-arteritic anterior ischemic optic neuropathy as a side effect with a frequency of “very rare.”
The Pink Sheet explores how regulatory approvals for Leqembi differ around the world, and looks at what is coming next.
Experts from EUCOPE explain why the Council of the EU’s position on the proposed overhaul of the general pharmaceutical legislation could offer more predictability for companies than the commission’s initial offering.
