May Health Gets CE Mark Approval for PCOS Fertility Device

• May Health has obtained CE Mark approval for its Anavi System, aimed at treating infertility associated with PCOS
• This certification was made possible by the EU Medical Device Regulation (EU MDR)

May Health, a firm that specializes in developing medication and device solutions for women with polycystic ovary syndrome (PCOS), has received CE Mark approval for its Anavi System, which has been developed for treating infertility associated with PCOS.

This approval under the European Union Medical Device Regulation (EU MDR 2017/745) enables May Health to market its device within Europe.

PCOS is estimated to affect 10-13 percent of women worldwide and is considered the most prevalent endocrine disease affecting women of childbearing age. In fact, it is one of the major causes of infertility in females as well.

In most cases, females with PCOS face irregularities or an absence of ovulation because of hormonal imbalances in the ovaries. Although primary medications are used as a major means for ovulation induction, these are not effective for all females.

In such scenarios, when failure occurs, treatment is advanced to more invasive and expensive therapies such as laparoscopic surgery and in vitro fertilization (IVF), so much so that some females refrain from such treatment modalities.

The Anavi System is designed for women with PCOS-related infertility that is non-responders, non-candidates, or non-adherent with first-line medications, and is intended to be a one-time in-office treatment.

The System is based on the adaptation of concepts from Laparoscopic Ovarian Surgery to a direct ultrasound-guided, in-office device.

Employs focalized radiofrequency energy to address a small part of the ovarian tissue, hopefully to resume ovulation, providing a hope for those patients who are not yet ready to proceed with IVF.

CE Mark approval was based on safety and feasibility trial results from clinical studies carried out in Europe and the United States.

These studies were performed on women with PCOS who were an ovulatory or had irregular ovulations and who had not achieved response to conventional drug treatment or were not able or unwilling to undergo the treatment.

Preliminary outcomes from the 2025 European Society of Human Reproduction and Embryology Annual Meeting reported that a considerable number of patients had ovulation within 12 months of the procedure, with some achieving pregnancy. Mild procedure-related adverse events included vaginal bleeding, pain, and headaches.

The CE Mark allows May Health to start the commercial distribution of Anavi System in European countries. At the same time, May Health is also performing the REBALANCE study in the United States. This is a pivotal trial aimed at paving the way for approval of U.S. FDA market clearance.

Company representatives highlighted that the approval is a step forward with regards to treating PCOS-induced infertility among women and said that the potential of an office-based, non-hormonal therapy obtaining ovulation is a good thing.