Image: Mira

Mira is the creator of an at-home test that offers a personalized and lab-quality tracking system for monitoring women’s reproductive health. It uses patented AI algorithms to accurately measure the levels of major hormones in a woman’s urine to provide a holistic view of a woman’s reproductive health.

Today the company announces that it has received a greenlight from the FDA for its Progesterone (PdG) Confirm Wand allowing its entry into the US market. Progesterone is an essential hormone responsible for regulating the menstrual cycle and preparing a person’s body for pregnancy. Monitoring progesterone levels in the blood can help confirm ovulation, which is important for an individual who wishes to get pregnant. 

Progesterone testing is a gold standard for ovulation monitoring, providing valuable insights into a person’s cycle health and ability to conceive and carry a fetus. It is an essential aspect of fertility treatments and helps diagnose possible causes of infertility. However, continuous monitoring of pregnanediol glucuronide is required for more accurate diagnosis and monitoring treatment progress.

Mira provides a safe, non-invasive, and fast alternative for hormone testing from the comfort of a bathroom. “The Mira system is considered as a Class I medical device, which means that it has minimal to no potential risk to the user. Getting reviewed and passing FDA’s rigorous review proves that it’s safe and effective” says Sylvia Kang, CEO of Mira. To be FDA-registered, all medical devices, like Mira, need to submit requirements like clinical trials and performance research to FDA. 

Most other Class I and II medical devices have an FDA clearance but not an approval. FDA only gives its approval to Class III devices, which has a high risk potential to health. Breast implants and pacemakers fall into this category.

The PdG Confirm wand is the newest addition to the company’s existing line of hormone test wands. Prior to its launch, Mira offers two hormone wands, the Mira Fertility (luteinizing hormone) and Mira Fertility Plus (luteinizing hormone + estrogen).

“With the launch of our PdG wands, we now have a complete system hormone test package that gives individuals a holistic view of their cycle and obstetric health. For existing and future Mira users, obtaining the FDA mark for Confirm wands means that the device is now approved as an accurate tool to confirm ovulation”, continues Kang. 

Mira’s Confirm Wand is compatible with the Mira Analyzer, a high-precision fluorescent-based testing device that uses patented machine learning to track a person’s unique and ever-changing hormone patterns measured over time, further setting the AI-powered Mira System apart from OTC ovulation strips. These patterns are displayed in easy-to-understand visual and numerical data along with personalized insights on their reproductive health, on the Mira App. Mira’s Confirm wand can be used as a standalone or in combination with other Mira wands.

“Mira’s ability to accurately measure and track progesterone levels at home is a technological breakthrough helping to support women on their journey to conception”, says Apurva Shah, a board-certified OB/GYN and Member of the Mira Medical Advisory Board. “Until now, there was a lack of clarity on the progress of the cycle after the predicted fertility window detected with at-home LH kits. PdG wands provide the much needed clarification by confirming ovulation and sustained luteinization until the first detection of pregnancy”, adds Dr.Shah.

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