Advanced Neuromodulation Systems CE-marks Genesis IPG (implantable pulse generator) system:
This article was originally published in Clinica
Advanced Neuromodulation Systems has CE-marked for sale in Europe its Genesis totally implantable pulse generator spinal cord stimulator for pain relief. The Plano, Texas-based company says a decision is expected imminently from the US FDA as to whether the product can be reclassified as a class II device (from class III). The reclassification will allow ANS to submit the device to the FDA via the 510(k) marketing clearance process rather than the PMA route, which usually involves a longer procedure.
You may also be interested in...
As the MHRA prepares to grant approval to the Oxford/AstraZeneca vaccine, Wockhardt is set to supply 100 million doses for the UK government’s own use and its WHO commitments. The company is also in talks with global vaccine developers to manufacture their COVID-19 vaccines for emerging economies
A combined final opinion on the European Chemicals Agency’s proposed microplastic restriction is expected from ECHA committees by year-end, at which point the European Commission will consider whether and when microplastic must be removed from all leave-on cosmetic products marketed in the EU.