Initos Fertility Monitor is a small device that enables smartphones to perform lab-grade fertility diagnostic tests at home.

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 and 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 and safety for the end-user. Over the course of more than a year, Initos flagship device has been subjected to a series of clinical studies, manufacturing facility set up tests as per GMP standards, and company-wide quality management system, ensuring the reliability and efficacy of the device. “Inito has always been committed to building a global home diagnostic testing company headquartered out of India, and this milestone takes us one step closer to that ambition. 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 percent correlation with clinical-grade instrumentations which cost up to 100 times more and are ten times bigger, the statement said.

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Bengaluru: Over 320 children and adolescents died every day from AIDS and AIDS-related causes in 2018, states a recent report released by the UN International Children’s Emergency Fund (UNICEF).

To take care of the health needs of such children, Desire Society was set up in 2005 in Hyderabad. The NGO now has presence in five states, including in Karnataka (Bengaluru), and an overseas office in the United States. It focuses on disadvantaged children, with special emphasis on HIV-positive victims, children abandoned by one or both parents, children of sex workers, truck drivers, and kids who have been abused and those belonging to vulnerable socio-economic sections.

The NGO wants to ensure that no children in the country lives life as a HIV-positive. “We have been providing medical, nutritional and educational needs of our children. We have not lost a single child under our care. This year, we will focus on holistic development of our children,” said Shubash, co-founder and vice-president, Desire Society.

The NGO runs four programmes – Supply of supplementary nutrition through health camps, ICH (Institutional Care Homes), IEC (Information, Education, Counselling) – Knowledge-building and empowerment of infected children – and summer camps as an annual social event which are fun-based gatherings meant exclusively for children with HIV/AIDS.

Desire focuses on educating these children, helping them get employed, get married and start a family. Since HIV transmission from the parent to a child can be prevented, the organisation believes that children supported by it are eligible to get married. Desire boasts of taking care of next generation kids as well if their parents don’t survive.

One of the major impediments HIV-infected children face is the social stigma, which deprives them of school education. Once children are taken under its wings, Desire puts them under the medical observation of its healthcare team.

The children are made to take drugs regularly and on time as unless a patient takes antiretroviral therapy (ART), there are no results.

Regular counselling sessions are conducted to inculcate positive thinking in young minds. “Our aim is to work towards ensuring that no children in the country will be living a life of a HIV-positive. One of our present challenges is that we do not have our own land for the care centre. We have to pay a high rent so we are in need of funds to build a separate building for boys’ accommodation,” Mr Shubash said.

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