Mira's Confirm Wand Receives a Greenlight From the US FDA as an Accurate Tool to Confirm Ovulation
Mira's newly released progesterone test wands is now listed as an FDA-registered over-the-counter tool to detect pregnanediol glucuronide for the confirmation of ovulation.
PLEASANTON, Calif., October 25, 2021 (Newswire.com) - Mira's Progesterone (PdG) Confirm Wand received a greenlight from the FDA, allowing its entry into the US market.
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 need to submit requirements such as clinical trials and performance research to the FDA.
The PdG Confirm Wand is the newest addition to the company's existing line of hormone test wands. Prior to its launch, Mira had two hormone wands, Mira Fertility (luteinizing hormone) and Mira Fertility Plus (luteinizing hormone + estrogen).
"With the launch of PdG wands, we now have a complete system 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 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. This further sets 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 the users' reproductive health, on the Mira App.
Mira's Confirm Wand can be used as a standalone or in combination with other Mira wands. A 2021 study found that, when wands used in combination, Mira shows 28.6% higher accuracy than its major competitor and is able to detect whether ovulation has occurred with 99% accuracy, correlating with results of standard lab tests.
"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 LH kits. PdG wands provide the much needed clarification by confirming ovulation and sustained luteinization until the first detection of pregnancy," adds Dr. Shah.
Mira is the first at-home solution to offer a personalized and lab-quality tracking system for monitoring women's hormones. It uses patented AI algorithms to accurately measure levels of major female hormones to provide a holistic view of the reproductive health. Mira is FDA-approved, clinically approved, and OB-GYN recommended.
For more information on Mira, visit miracare.com.
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