A Modern Approach to Polycystic Ovary Syndrome (PCOS)
What it means for people who
Introducing: Ovarian Rebalancing™
May Health has developed an investigational treatment intended to restore ovulation. Through targeted ovarian ablation, this one-time treatment aims to lower androgen production, which has been shown to restore ovulation using other techniques. Ovarian Rebalancing™ can be done conveniently in an outpatient setting — no hormones necessary.
No One PCOS Experience Is the Same
That’s why we believe that along with modern treatment options, patients and physicians also need more knowledge.
We’re committed to bringing you information that’s objective and accessible — starting now — so that you can make the best decisions, whether it’s for yourself or your patients.
More to Come
We can’t make any claims about the treatment at this time, and for good reason.
May Health is in the clinical trial stage where we’re following FDA and EU regulations to validate the overall safety and effectiveness of the treatment. We look forward to eventually offering our treatment to patients in the US and Europe once FDA approval is granted in the US, and a CE Mark is granted in Europe.
The Process
To Launch and Offer a Medical Device in the US and Europe
Step 1: Device Discovery and Concept
Research for a new device begins in the laboratory.
Step 2: Preclinical Research — Prototype
Devices undergo non-clinical testing to answer basic questions about safety.
Step 3: Pathway to Approval
Devices are tested on people to make sure they are safe and effective.
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Step 4: FDA & European Notified Body Review
Teams thoroughly examine all of the submitted data related to the device and make a decision to approve or not to approve it.
Step 5: Post-Market Safety Reporting
The FDA and European Competent Authorities monitor device safety once products are available for use by the public.
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