Win For Axonics As England’s NICE Says Rechargeable Neuromodulation Is Cost-Effective
Health technology assessment body NICE is consulting on draft guidance that recommends Axonics' device for overactive bladder.
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The US FDA approved Axonics’ r-SNM sacral neuromodulation system for treating overactive bladder and urinary retention on 14 November. The agency approved the same device for treating chronic fecal incontinence on 9 September. Axonics expects r-SNM to rival Medtronic's InterStim II non-rechargeable sacral neuromodulation system, but Medtronic claims the r-SNM technology infringes on Medtronic’s intellectual property.
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add seven new products, including Nulibry, BridgeBio/Sentynl's orphan drug for treating molybdenum cofactor deficiency Type A.
Investigational products from Ultragenyx and MinervaX secured a place on the European Medicines Agency’s priority medicines scheme this month.