Bengaluru: Inito, a Bengaluru-based medical technology startup, has announced that 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 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.
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 setup tests as per GMP standards, and company-wide Quality Management System, ensuring the reliability and efficacy of the device.
