Natural Cycles uses an algorithm and other factors to determine which days a woman might be fertile.
Smartphone app Natural Cycles, the first app certified as a form of contraception in Europe, is setting its sights on the US next.
Though plenty of cycle-tracking apps exist, most of them don’t get the fertility window right. Natural Cycles uses a specially developed algorithm and other factors, including temperature, to determine which days a woman might be fertile. The certification is a “huge milestone,” says Natural Cycles co-founder Raoul Scherwitzl in an email.
The mobile health space is growing: about half of the 3.4 billion smartphone and tablet users will have downloaded mobile health apps by 2018, according to some estimates. And there’s no shortage of apps: there were 165,000 health apps available in 2015, according to reports. That number has almost certainly grown since, but very few health apps have been approved for medical purposes by the FDA; FDA approval requires clinical evidence and that’s expensive. New drugs cost about $1 billion to develop, but apps qualify as devices, so approval for them is cheaper at just $31 million to $350 million.
As for plans for US approval, Scherwitzl says the process is similar to the one in Europe. “You submit your dossier, including all your clinical data, to the FDA and they review it and approve it if it meets their standards,” he says.
Credit: The Verge