Inito, a Bangalore based medical technology startup announced that its Inito-fertility monitor has got clearance for regulatory pathway by the United States Food and Drug Administration (USFDA) on 2nd November 2020 to support fertility testing and realize cycle variations of every user giving the most exact results by enabling smartphones to carry out lab-grade fertility diagnostic tests at home. It is all set up for operations in the US.
Inito is the world’s first comprehensive at-home diagnostics device and App, founded in 2015. It’s Inito smart fertility monitor can connect to a user’s smartphone via iOS app or Android and give them a clearer insight into the most fertile days for couples striving to conceive. Inito incorporates testing for both estrogen and Luteinizing Hormone. The monitor links to Inito’s app and can measure both estrogen and LH to display the fertility window for couples. The app professes to show a fertility window of six days, ranging from low peak to high fertility.
The US Food and drug administration carried on firm regulatory control over all medical devices to ensure exactness and well-being for the end-user. The fertility monitor had to go through various inspections to confirm that it is safe to use. The Monitor received class one approval which means that according to the Food and drug administration it’s a device with the lowest degree of risks. The approval facilitated the way for the device launch in the US, and also let it access to countries that have signed the Mutual Recognition Agreement with the food and drug administration.
“We are very proud of the fact that we have built something that is of a global standard and meets all the norms set out by the FDA. We are not just building it for India, but for the world from India,” Aayush Rai, co-founder of Inito.
A study conducted by IIT Delhi shows that the device attained a 99.12% correlation with clinical-grade instrumentations that cost up to 100 times more and are ten times bigger.