A Medical Technology startup, Inito in Bengaluru has secured a class one approval from the US Foof and Drug Administration for the fertility monitor. Although they still need to go through the data of the clinical trials, the policy checks and the necessary requirements for manufacturing the product as per the US regulator. It is essential for the company to show that the fertility monitor is safe and accurate to use at home product.
Inito has been operational in India since 2018, they have developed the fertility monitor that can connect to any smartphone and get an accurate status of the fertility days of the couples. It gives the lab-grade diagnostic of the fertility tests at home. In the product, Inito tests the fertility hormones estrogen and Luteinizing Hormones (LH) in the urine, unlike the ovulation strips. As the ordinary ovulation apparatus normally looks at only the LH levels. A rise in the LH shows the beginning of the ovulation period.
After the Inito’s fertility monitor is connected to the smartphone through the Inito’s app. One can monitor the fertility period and status of their LH and estrogen. Inito asserted that they will show the fertility window and monitor the range of fertility over the six days.
In order to ensure the credibility and efficiency of the device, the company had conducted a sequence of tests including clinical tests and determined the standard manufacturing of the device. The study conducted by the IIT, Delhi found that the fertility monitor has reached 99.12% accuracy to the clinical grade diagnosis which apparently would cost a hundred times more.
Aayush Rai, Inito’s founder said that home diagnosis has become an integral part of the medical system and they are proud to have contributed to the innovation. They have also obtained the patent on the flat-lens technology that would help the people to get fertility diagnostics at home including diabetes, thyroid and also check for Vitamin D.
Inito also stated that apart from monitoring the fertility hormones, the device would also give an insight into the medical condition of the individual. For instance, a couple is trying to conceive but they may not know about the reason. It could be PCODs, the device would show the condition.
With the increasing trend among people majorly in the urban areas of marrying late. People believe that before marrying they should be well-settled in life with a good job and a stable salary. This often takes time resulting in late marriages. Many women, especially in urban areas, are increasingly becoming health conscious and image-conscious, this results in them either conceiving later in their lives. In 2018, it was found that around 10%-14% of people face fertility problems which are likely to increase due to the modern lifestyle in urban areas.
While developing the product, Inito found that people are supposed to dip the regular strips in the urine for at least 15 seconds however, it is observed that they dip the strip only for 5 seconds. This would often give them wrong results, if not accurate. They said that the fertility device, in this case, would tell the person that it is not dipped for the right time rather than giving the inaccurate result.
Founder of Inito, Rai also said that they will soon be launching two more products which would complete the fertility kit, it tests Progesterone and FSH. Although the clinical tests are done, the development is pending and the product will be launched soon in the market.