BENGALURU: Bengaluru-based medical technology startup Inito on Monday 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 with the FDA, it said in a statement.
Initos Fertility Monitor is a small device that enables smartphones to perform lab-grade fertility diagnostic tests at home, it said.
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.
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.
"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.
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 per cent correlation with clinical-grade instrumentations which cost up to 100 times more and are ten times bigger, the statement said.