Inito’s Fertility Monitor is a small device that enables smartphones to perform lab-grade fertility diagnostic tests at home
Inito, a Bengaluru-based medical technology startup, announced that its fertility monitor has cleared the regulatory pathway of the United States Food and Drug Administration (FDA). 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 setup tests as per GMP standards, and company-wide Quality Management System, ensuring the reliability and efficacy of the device.
“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.