On September 17, 2026, FemPulse, a bioelectronic medicine company based in Vienna and San Francisco, announced that the FemPulse Ring had received CE Mark certification under the EU Medical Device Regulation (MDR) and is now listed in EUDAMED, the EU medical-device database. Urology Times covered the clearance on September 24. The ring is a wireless, wearable neuromodulation device for overactive bladder (OAB) that women insert vaginally, wear continuously and remove themselves. It sits in the upper vagina and uses eight programmable surface electrodes to stimulate the nerves that carry signals between the bladder and the spinal cord.

Why It Matters

Pelvic-health devices are where femtech hardware and sexual-wellness hardware increasingly share engineering, retention mechanics and body-safe materials questions. A continuously worn, self-managed intravaginal electronic device that clears the EU's stricter MDR regime sets a regulatory precedent for "wearable inside the body" categories, including future sensing and stimulation products that sit closer to sexual health. It also positions neuromodulation, which is usually delivered by surgically implanted stimulators, as a first-line consumer-managed therapy. That is the same shift from clinic to home that Elvie and Perifit made for pelvic-floor training. The business test is reimbursement and uptake in Europe before a U.S. readout around late 2027. Treat the efficacy claims as the company's until peer-reviewed pivotal data are published.

FemPulse says positive safety and efficacy data from four clinical studies supported the CE mark. In the U.S. the device is still investigational. Its pivotal trial, EVANESCE-II (NCT07195656), will randomise up to 151 women with OAB 2:1 to the ring or to the standard drug tolterodine. The primary endpoint is non-inferiority in mean change in daily voids at week 26, and Urology Times reports study completion is expected in December 2027. "I am excited that the over 50 million women in Europe suffering from OAB will now have access to our non-invasive, patient-friendly therapy," said urogynecologist Dr. Alexandra Haessler, the device's developer and FemPulse's founder and CMO. FemPulse GmbH president Thomas Huber said the company will use "AI-agentic direct outreach" to women who have "self-identified as without an acceptable treatment option." Named investors include former Medtronic chairman and CEO Bill Hawkins and German industrialist Jürgen Hambrecht.

Sources

Update — 2026-09-30

Initial entry — story first created.