The FDA has listed Mira’s new Mira Ovum Wand as an over-the-counter tool to detect the follicle-stimulating hormone (FSH) in urine. Starting October 2022, the product will be available to U.S. customers. The wands help monitor FSH levels to predict approaching menopause. They can also be used to monitor fertility and find possible causes of reproductive issues for women after 35.

Menopause has been a taboo subject for many generations. The lack of relevant education results in numerous misconceptions about this time in women’s lives. Studies show that to this date, one-third of women do not research the topic before they experience menopause. A survey of 1,039 American women ages 40-65 finds that 45% of them didn’t know the distinction between perimenopause and menopause. The Mira Ovum Wand can provide information to help understand perimenopause, predict menopause and address the symptoms early. FSH tracking can also help track the effectiveness of hormone replacement therapy to make it more targeted and personalized.

Tracking the follicle-stimulating hormone is essential for women in their 20s, 30s, or 40s because it directly impacts their ability to get pregnant. To predict approaching menopause or track changes in fertility, a person needs to test over several days for two or more cycles. Mira allows users to safely and regularly monitor their FSH levels at home without the need for constant and painful blood tests. And unlike FSH test strips, Mira provides lab-accurate numbers and data points that are saved and analyzed to give users personalized health insights. Users can also choose to share this data with their medical provider.

“The Mira Ovum Wand further expands our capabilities in at-home hormone testing. We can now provide accurate lab-like results for LH, E3G, PdG, and FSH. The launch reinforces Mira’s goal to support women throughout their lives by helping them understand their hormones at any age, be it puberty, adulthood, or later years. This knowledge grants the ability to make informed fertility decisions and eliminates the dread associated with the word “menopause.” So, women can go through this journey with confidence and awareness,” says Sylvia Kang, CEO of Mira.
Mira offers a whole line of hormone test wands, including Mira Fertility (luteinizing hormone), Mira Fertility Plus (estrone-3-glucuronide and luteinizing hormone) and Mira Confirm (pregnanediol glucuronide). Like its predecessors, the new Mira Ovum Wand is compatible with the Mira Analyzer. This high-precision testing device uses machine learning to track changing hormone patterns over time, making Mira more effective than regular ovulation strips. The analyzer can be connected to Mira App to display clear numerical data along with personalized insights on the user’s reproductive health.

Source: Company Press Release