FemPulse has won CE Mark certification under the EU Medical Device Regulation for the FemPulse Ring, a self-inserted vaginal neuromodulation device the company positions as a non-surgical, drug-free first-line option for overactive bladder. The Minnesota company announced the certification on 17 September 2026, opening the European market to a device that remains investigational and unapproved in its home country.
A ring the patient inserts and removes herself
FemPulse’s device is a foldable silicone ring, self-retained in the upper vagina once inserted, carrying eight programmable surface electrodes. It delivers mild electrical stimulation intended to act on the nerves that control bladder function, aiming to reduce the sudden, hard-to-control urge to urinate that defines overactive bladder (OAB). The company describes it as a wearable, continuous-use device a patient inserts and removes herself, without surgery, an implant, or a daily pill. Dr. Alexandra Haessler, a fellowship-trained urogynecologist and the device’s inventor, developed the technology before FemPulse was built around it.
“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.” Dr. Alexandra Haessler, urogynecologist and inventor of the FemPulse Ring — 17 September 2026 announcement
The FemPulse Ring, in four numbers
Figures from FemPulse’s public announcements.
What FemPulse's CE mark actually certifies
A CE Mark under EU MDR means an EU notified body has assessed the device against European safety, quality and clinical-performance requirements — it is the legal basis to market the device in the EU, comparable in function to an FDA clearance or approval but issued by a private notified body rather than a government regulator. FemPulse says the FemPulse Ring is now listed in EUDAMED, the EU’s public device database; Regulatory News was unable to independently pull that EUDAMED record before publication and will update this page if that changes. The company has not named the notified body that reviewed the device or disclosed the specific clinical endpoints the four supporting studies measured.
Three reasons this isn't just another neuromodulator
No implant, no surgery
Where most nerve-stimulation therapies for OAB require an implanted device, the FemPulse Ring is inserted and removed by the patient herself, closer in form factor to a menstrual cup than a surgical implant.
A physician-inventor's own device
Dr. Alexandra Haessler, a practicing urogynecologist, developed the underlying technology herself before FemPulse was built around it.
Two regulatory tracks running in parallel
The device already holds an FDA-approved Investigational Device Exemption for a U.S. pivotal trial, alongside this newly won EU CE Mark — two separate paths toward two separate markets.
Where a self-inserted ring sits among implanted options
Neuromodulation for overactive bladder is not a new idea; it is a crowded field of mostly implanted or percutaneous devices. Medtronic’s InterStim system, a market-leading implanted sacral neuromodulator, and Axonics’ smaller, rechargeable implantable system both require a surgical procedure to place. Medtronic’s Nuro and BlueWind Medical’s Renova iStim take a less invasive route, delivering stimulation through the skin or a small implant near the ankle. FemPulse’s pitch is that its ring skips implantation altogether.
FemPulse against other OAB neuromodulation devices
| Device | Placement | Regulatory status | What sets it apart |
|---|---|---|---|
| FemPulse Ring | Self-inserted vaginal ring; no implant | EU MDR CE Mark (September 2026); U.S. pivotal trial ongoing under FDA IDE | Patient inserts and removes it herself; no surgery required |
| InterStim (Medtronic) | Implanted sacral neuromodulation device | FDA-approved; long-established market leader | Surgically implanted; continuous therapy without daily patient action |
| Axonics system | Implanted, rechargeable sacral neuromodulation device | FDA-approved | Smaller implant and longer battery life than earlier implanted systems, per the maker |
| Renova iStim (BlueWind Medical) | Small implant near the ankle, tibial neuromodulation | In pivotal trial | Positioned as a less invasive alternative to sacral neuromodulation |
From each company’s own public product descriptions; not a head-to-head clinical comparison.
Overactive bladder therapeutics, two forecasts to 2030
Global OAB burden vs. a fragmented device market
FemPulse cites more than 50 million women in Europe with OAB; the global figure is commonly estimated at roughly one in five women. No single published market-size consensus exists for OAB neuromodulation devices specifically, unlike the drug side of the category.
Sources: FemPulse, CE Mark announcement, 17 September 2026
Regulatory News outlook
We expect FemPulse’s addressable market to grow with word-of-mouth adoption among women who have already rejected surgery or long-term medication, rather than by displacing implanted systems whose patients have typically failed more conservative options first.
How we got here: No independent, device-specific market-size forecast for non-implanted OAB neuromodulation exists yet; we treat the company’s own 50-million-women Europe figure as an upper bound on addressable patients, not a revenue estimate, since only a fraction of any patient population adopts a newly certified device in its first years on the market.
Two separate regulatory tracks, an ocean apart
From a U.S. trial green light to a CE mark
- December 2024
FDA IDE approval
FDA approves an Investigational Device Exemption for FemPulse’s U.S. pivotal clinical trial — a separate track from any EU regulatory activity.
- 15 September 2026
Clinical data announced for ICS
FemPulse says clinical data will be presented at the International Continence Society’s annual meeting.
- 17 September 2026
EU MDR CE Mark certified
The FemPulse Ring wins CE Mark certification, opening the EU market; the company says it is now listed in EUDAMED.
- 9 October 2026
ICS presentation, Maastricht
FemPulse clinical data scheduled for presentation at the International Continence Society annual meeting.
- Not yet dated
U.S. pivotal trial completion
No completion date or FDA submission date has been disclosed for the U.S. track.
The two tracks matter because they run on different clocks and different evidence bars: the EU CE Mark rests on four completed studies the company has not fully detailed, while the FDA path requires a dedicated pivotal trial under the IDE granted in December 2024, with no disclosed completion date. A European commercial launch does not shorten the American one.
- EU commercialization: FemPulse’s European operations run through a Vienna, Austria subsidiary; the company has not disclosed specific launch countries or a rollout timeline.
- U.S. status: investigational only; a pivotal trial is ongoing under the FDA’s December 2024 IDE approval, with no disclosed completion date.
- Not yet public: the notified body that reviewed the CE Mark application, the specific endpoints from the four supporting clinical studies, and total funding raised to date.
Sources & further reading
- FemPulse, “FemPulse Ring Gains CE Mark Certification for the EU,” press release, 17 September 2026. globenewswire.com
- “Fempulse Ring secures CE mark for overactive bladder in women,” BioWorld, 17 September 2026. bioworld.com
- ClinicalTrials.gov, “FemPulse Therapy for Overactive Bladder in Women,” NCT03784170. clinicaltrials.gov
- FemPulse, “FemPulse Receives FDA IDE Approval for the Pivotal Clinical Trial of its Wearable Bioelectronic Device for Overactive Bladder in Women,” press release, 11 December 2024. globenewswire.com
- FemPulse, “FemPulse Clinical Data to be Presented at ICS on October 9,” press release, 15 September 2026. globenewswire.com
Regulatory News reports on public regulatory documents. It is not legal advice, and the primary sources above govern. If we have made an error, we will say so in public: see corrections.
Frequently asked questions
What did FemPulse win, and when?
CE Mark certification under the EU Medical Device Regulation (MDR) for the FemPulse Ring, announced 17 September 2026. The company says the device is now listed in EUDAMED, the EU’s device database; Regulatory News was not able to independently pull that record before publication.
What does the FemPulse Ring do?
It is a foldable silicone vaginal ring that a woman inserts and removes herself, carrying eight programmable electrodes that deliver mild electrical stimulation to nerves controlling bladder function, intended as a non-surgical, drug-free first-line option for overactive bladder.
Is the FemPulse Ring available in the United States?
No. It remains investigational in the U.S. FDA approved an Investigational Device Exemption for FemPulse’s pivotal trial in December 2024, which is separate from and unrelated to this EU CE Mark; a U.S. approval would require its own FDA submission after that trial completes.
What evidence supported the CE Mark?
FemPulse says the certification was supported by data from four completed clinical studies showing positive safety and efficacy results. The company has registered earlier feasibility studies of the device on ClinicalTrials.gov.
