Inito clears US FDA regulatory pathway for Fertility Monitor

Inito, a Bengaluru-based medical technology startup, has said its Fertility Monitor has cleared the regulatory pathway of the United States Food and Drug Administration (FDA).

By clearing this, Inito has become the first designed, engineered and manufactured in India home diagnostic device to achieve this milestone. This 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.

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 & 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.

The US FDA maintains strict regulatory control over all medical devices to ensure accuracy and safety for the end-user. Over the course of more than a year, Inito’s flagship device has been subjected to a series of clinical studies, manufacturing facility set-up tests as per GMP standards, and company-wide Quality Management System, ensuring the reliability and efficacy of the device.

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

“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
of 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 percent
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.

Inito is India’s first Y Combinator backed medical device startup building the next generation of home diagnostic devices that are not just accurate and reliable, but are also smart and easy to use.

Pic source: Inito

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