On 9th November 2020, Inito, a Bengaluru-based medical start-up received approval from the US Food and Drug Administration (FDA) for launching its Fertility Monitor in the U.S. The co-founder of the company, Aayush Rai has informed The Indian Express that it is a very proud moment for the people of the company. Aayush also mentioned that they are very glad that their invention can be implemented on a global level and not just in the U.S. or India. The company has made a breakthrough that Aayush mentions as a development for the rest of the world from India. The Fertility Monitor has passed all the rules of the FDA and all set for launch in the international market.
Inito received Class One approval
Fertility Monitor is a home-based user testing product and thus has to go through various scrutinies to prove that it is safe to use. The Fertility Monitor received class one approval and it means that according to FDA it is a device with the lowest degree of risks. This is a very impressive invention for a start-up to receive a class one approval given that the use of medical instruments is very sensitive. The company is still required to show the clinical trial data, pass all the levels of scrutiny for manufacturing requirements, and other rules of the U.S. regulator. The main goal of the Fertility Monitor is to see if it works both safely and accurately.
Work environment
As the U.S. has grant approval for the Inito Fertility Monitor, they are preparing for setting up an operation in the U.S. Inito should strictly abide by the U.S. regulatory standards apart from creating a huge user base and run smooth production operation. Many factors especially the physical environment should be maintained at an optimum condition for proper production. For example, temperature is one of the major factors that play a role in using medical devices. So, a lot of pre-processing is required before production starts in the U.S.
How the device will work?
The Inito smart Fertility Monitor can be connected to a user’s smartphone by installing the app for Android or iOS. This will help couples give a clearer view of the most fertile days when they are trying to conceive. Many couples struggle to conceive and hence it is a huge advantage to get access to such a device at home. Inito doesn’t work like the regular ovulation strips rather it combines testing for both estrogen and Luteinizing Hormone (LH). Many ovulation testing kits are available on the market but they only test the LH level. But, the presence of high LH is not the only indication of high chances of fertility.
So, Inito’s Fertility Monitor measures both the estrogen and LH level and connects it to the phone’s app, and shows a certain period of six days as the fertility window. The smart monitor not only displays the level of estrogen and LH but also shows the probability of fertility from low to high in the six-days window. Moreover, through the level of these hormones, other health issues can be predicted as well. If you observe an abnormal level of estrogen and LH you can then consult the doctor to figure out if there is any other complexity in your body. The company through this invention is trying to help figure out couples the best time to conceive as according to the Indian Society of Assisted Reproduction (ISAR), 10-14% of couples in India face fertility issues.
More about Inito
In India, Inito sells its Fertility Monitor along with strips via Amazon. Currently, Bangalore is their biggest market but their market is also growing in tier-2 and tier-3 cities. Aayush said that the product they have developed requires a very educational background to adopt it quickly. Since sexual education is still a subject of taboo in our country, maybe the product is taking time to expand in small cities.
Inito’s developments are very forward-thinking and show an accurate result. This company is the first-ever medical device start-up from India to secure funding from Y-Combinator. The company plans to add more hormones to the test both in the field of fertility and beyond. The company will further focus on testing for thyroid, vitamin D, testosterone, and HBa1c.
Annasha Dey is an NIT student, who apart from studying engineering is also a content writer. She has a great interest in photography, writing, reading novels, and travelling as well. She is a foodie who loves socializing and hanging out with her friends. She is also a trained Kathak dancer and a big fashion enthusiast. Dey also loves watching TV series, which includes F.R.I.E.N.D.S. and Big Bang Theory. To be a better writer she prefers to read more