Genio system
Commercial- Indications
- Moderate to severe Obstructive Sleep Apnea
Company intelligence / Profile preview
FemPulse has completed earlier clinical studies and received FDA Investigational Device Exemption (IDE) approval in December 2024 to begin its pivotal EVANESCE II trial for overactive bladder in women. The device offers a minimally invasive alternative to pharmaceutical and surgical treatments by providing continuous neuromodulation via a vaginal ring. The system has also advanced to the final stage of the EU Medical Device Regulation process for commercial clearance
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