In A First, Bengaluru's Inito Clears FDA Regulatory Pathway For Fertility Monitor Devices

The clearance will allow Inito to launch its product in the US, and also give access to countries that have signed the MRA with the FDA

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Homegrown medical technology startup Inito on Monday announced that its fertility monitor has cleared the regulatory pathway of the US Food and Drug Administration (FDA). The Bangalore-based startup claims to be the first indigenously designed, engineered and manufactured home diagnostic device to have achieved this milestone. With this approval, the device can now be launched in the US and will also allow other countries those who signed Mutual Recognition Agreement (MRA) with the FDA to access it.

Inito Founders

Inito’s Fertility Monitor is a small device that enables smartphones to perform lab-grade fertility diagnostic tests at home. By measuring two fertility hormones in urine—estrogen and luteinizing Hormone (LH)—along with AI-based data analytics in the app, Inito understands the cycle variations for every individual user, giving highly accurate results unique to every woman’s body.

Founded in 2015 by IITians Ayush Rai and Varun AV, the startup aims to help people get healthier and happier while reducing the burden on the healthcare system and doctors. The startup is India’s first Y Combinator backed medical device startup.The startup’s  proprietary technology allows a single device to do dozens of diagnostic tests at home.

Commenting on the development, Rai, co-founder of Inito, said, “Inito has always been committed to building a global home diagnostic testing company headquartered out of India, and this milestone takes us one step closer to that ambition. The coming years will see home diagnostics become an integral part of the medical ecosystem, and we’re proud to be among the leaders of this revolution.”

“Clearing the FDA regulatory pathway speaks of the commitment and dedication of our team, who have upheld the highest standards of engineering, user experience, and clinical validation throughout the course of development,” he further added.

In a statement, the startup noted the clearance has come at a time when the country is grappling against the pandemic which is burdening the already stressed out healthcare system. It pointed out that couples who are facing trouble in conceiving are having a difficult time as they have nowhere to go. The company claimed that its fertility monitor offers millions of aspiring parents a chance to overcome these difficulties without stepping out of their homes.