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.
Axonics Modulation Technologies Inc. is fighting Medtronic PLC in both the incontinence-treatment device market and in the courtroom.
Axonics’ rechargeable sacral neuromodulation (r-SNM) system competes with Medtronic’s InterStim and InterStim II sacral neurostimulation systems, which are indicated for treating urinary retention, overactive bladder and chronic fecal incontinence in...
The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.
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Fujirebio Diagnostics' Alzheimer's disease test, Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, has been cleared by the US FDA.
