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Inito clears US FDA regulatory pathway for fertility monitor

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Becomes first Indian home diagnostic device startup to achieve the milestone

Bengaluru-based home diagnostics startup Inito’s fertility monitor has cleared the regulatory pathway of the United States Food and Drug Administration (FDA, which paves the way for the product’s launch in the US, and also allows access to countries that have signed the Mutual Recognition Agreement (MRA) with the FDA.

Y Combinator backed medical device startup 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 luteinising 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.

As part of the US FDA’s process to ensure accuracy and safety of medical devices for end-users, Inito’s flagship device was subjected to a series of clinical studies, manufacturing facility setup tests as per GMP standards, and company-wide Quality Management System, over the course of more than a year.

The clearance of the regulatory process of the fertility monitor for the US market comes at a particularly critical juncture due to the ongoing COVID-19 pandemic. The rapid spread of the disease has overwhelmed an already burdened healthcare system, with hospitals focused entirely on its treatment and containment.

As a result, many couples facing trouble conceiving have been left with nowhere to turn. This issue is especially pressing given the difficulty many couples face in getting pregnant, with 1 in every 3 couples taking over six months to conceive. Inito’s fertility monitor offers millions of aspiring parents a chance to overcome these difficulties without stepping out of their homes.

“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,” said Aayush Rai, co-founder, Inito. “Clearing the FDA regulatory pathway speaks to 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 added.

Inito’s patented ‘Flat-lens’ technology allows dozens of diagnostic tests for fertility, diabetes, Vitamin D, thyroid etc. and more on a single device connected to a smartphone. A study by IIT Delhi determined the device to achieve a 99.12 per cent correlation with clinical-grade instrumentations which cost up to 100 times more and are 10 times bigger. As of now, the device supports fertility tests and other tests like diabetes, thyroid and Vitamin D tests are soon to be added to the device.

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