FemPulse Receives FDA IDE Approval for Wearable Overactive Bladder Therapy
• FemPulse has received FDA IDE approval to begin its EVANESCE II pivotal clinical trial for its overactive bladder (OAB) therapy in women.
• The FemPulse Ring, a vaginally-inserted wearable device, provides continuous neuromodulation therapy as a non-surgical alternative for OAB.
• The EVANESCE II trial will compare the FemPulse Ring against first-line medication, aiming to establish it as a viable first-line treatment option.
• FemPulse's technology has advanced to the final stage of regulatory approval in the EU, with potential commercial availability in 2025.
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