The European review and certification company Tüv Süd gave Organic Cycles a CE certificate in February, and that implies the app is currently considered a medical device for contraception in Europe. Scherwitzl claims the program has repeatedly demonstrated in a set of studies that it boosts the effectiveness of conventional planning procedures to acquire the CE certification. Bodies are firms whereas the European Medicines Agency gives certification for pharmaceuticals like Tüv, which computes medical instruments. EU member states pick the notified bodies, which are organizations that assess whether devices fulfill with requirements. Scherwitzl says the approval route that is identical was followed by Natural Cycles .
The app works like this: each dawn, users measure their temperature, logging it. Natural Cycles employs an algorithm to calculate if the day is green, red, when fertility is likely, or meaning not fertile and utilizing protection is recommended. The Swedish-based company charges #39.99 ($52) for a yearly program, which contains a thermometer, or #5.99 ($7.80) each month. The company says its clinical studies have revealed that the program is effective for contraception, “comparable to the contraceptive pill,” and it has over 300,000 consumers in 161 nations.
The mobile wellness space is growing: about half of the 3.4 billion smartphone and tablet computer users may have downloaded mobile health programs by 2018, according to some quotes. And there is no lack of programs: there were 165,000 health apps available in 2015, according to reports. That number has improved since, but the FDA has approved for medical purposes health apps; signs is required by FDA approval and that is expensive. New drugs cost approximately $1 billion to develop, but apps qualify as apparatus, so approval for them is more economical at just $31 million to $350 million.
Real-world data — which is gathered from sources away from regular clinical trials — may “provide powerful insight into the benefits and risks of medical devices, including how they’re used by medical care providers and patients,” says Deborah Kotz, an FDA spokeswoman, in an email. The FDA is “working to execute” a national test system for wellness technologies to be certain that information is top quality and trustworthy.
There are limitations , namely that the program does not prevent STDs. And it will not stop users from having unprotected sex during their fertile period, either. In actuality, about half of the women in a study of pure Cycles got pregnant because they had unprotected sex while the app said they had been fertile. A condom might have prevented that.
In terms of strategies for US approval, Scherwitzl says the practice resembles the one in Europe.
Though plenty of cycle-tracking apps exist, most of these do not get the fertility window right. Natural Cycles uses a specially developed algorithm along with other factors, including temperature, to determine which days a woman may be fertile. The certificate is a “huge milestone,” says Natural Cycles co-founder Raoul Scherwitzl in an email.
Natural Cycles’ certificate in the united kingdom is a “big step in the right direction,” Jennings says. It means that users can make certain that the thermometer that is corresponding and the program operate nicely, ” she says. “What we don’t know is its effectiveness if it’s analyzed under rigorous study,” Jennings says. “I expect that will be coming.”
She noticed that the FDA has not yet cleared, granted, or approved any fertility programs.
The research involved women who were using the app without “any interactions with healthcare professionals,” states Scherwitzl. He claims the whole pharmaceutical industry is directed at this model, “because regulators demand it.”
“At the crux of any regulatory certification is strong, clinical proof that the item works as intended,” Scherwitzl states. “Our ambition is to get Natural Cycles certified in every state of the world.” His spouse, particle physicist Elina Berglund — part of this Nobel Prize-winning group that discovered the Higgs boson and he — founded the business together. Though she had used a hormonal implant as birth control for decades, they wanted to change to the rhythm method to prevent pregnancy, just if Berglund did want to get pregnant later.
“The printed research (to date) does not meet contraceptive efficacy standards,” Jennings says. “It may well be that such a research has been done, but it is not available in the published literature.”
Smartphone app Natural Cycles, the program licensed in Europe as a kind of contraception, is setting its sights next.