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Bengaluru startup Inito gets USFDA approval for fertility fertility monitor

Saransh Pandey

Intern
  • November 04, 2020
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    The company in its statement said that this had led the way for the product's launch in the US, and also allows access to countries that have signed the Mutual Recognition Agreement with the FDA.

Inito a Bengaluru-based medical technology startup announced that its Fertility Monitor has successfully cleared the regulatory pathway of the United States Food and Drug Administration (FDA). The company in its statement said that this had led the way for the product's launch in the US, and also allows access to countries that have signed the Mutual Recognition Agreement with the FDA. Initos 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 said it understands the cycle variations for every individual user, giving highly accurate results unique to every woman's body. According to Aayush Rai, Co- Founder of Inito  said that the coming years will see home diagnostics become an integral part of the medical ecosystem, and they are proud to be among the leaders of this revolution. 

The US FDA maintains strict regulatory control over all medical devices to ensure accuracy & 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. 

Inito said its patented 'Flat-lens' technology allows dozens of diagnostic tests for fertility, diabetes, Vitamin D, and Thyroid, among others, 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 instrumentation which cost up to 100 times more and are ten times bigger, the statement said. 

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