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.
The European inspection and certification company Tüv Süd gave Natural Cycles a CE certification in February, which means the app is now considered a medical device for contraception in Europe. To get the CE certification, Scherwitzl says the app has repeatedly demonstrated in a series of clinical studies that it improves the effectiveness of traditional planning methods. Notified bodies are companies like Tüv, which certify high-risk medical devices, whereas the European Medicines Agency gives certification for pharmaceuticals. EU member states pick the notified bodies, which are organizations that assess whether medical devices meet requirements set out in legislation. Scherwitzl says Natural Cycles followed the same approval path as the Durex Condom.
“At the core of any regulatory certification is strong, clinical evidence that the product works as intended,” Scherwitzl says. “Our ambition is to have Natural Cycles certified in every country of the world.” He and his wife, particle physicist Elina Berglund — part of the Nobel Prize-winning team that discovered the Higgs boson — founded the company together. Though she’d used a hormonal implant as birth control for years, they wanted to switch to the rhythm method to avoid pregnancy, just in case Berglund did want to get pregnant later.
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.
Source: The Verge
