Swedish regulator says contraceptive app works as marketed

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The Swedish Medical Merchandise Company has determined that Pure Cycles, the primary app to be certified for contraceptive use, works prefer it says it does. It launched an investigation into the app after Stockholm’s Södersjukhuset hospital reported that it brought about 37 undesirable pregnancies. That quantity was taken from a research involving 668 girls who went to the hospital searching for an abortion. Now, the Swedish MPA has closed its investigation after concluding that the speed of reported unplanned pregnancies amongst Pure Cycles customers is consistent with the standard use effectiveness charge of 93 %, primarily based on a study of over 22,000 girls that the corporate performed in 2017.

The regulator got here to that call after wanting into stories of unplanned pregnancies amongst girls who used the app between January and June 2018. However even the quantity in Södersjukhuset’s report checks out: 37 out of 668 girls exceeds the 93 % effectiveness charge. When requested in regards to the hospital’s report, Pure Cycles insisted that the numbers have been “consistent with what [it] talk as the danger of undesirable being pregnant with typical use, and which is akin to different kinds of contraception.” The Swedish MPA initially requested the corporate to point the danger of unintended being pregnant within the app’s directions. For the reason that utility already rolled out an replace with that change earlier this 12 months, although, the corporate did not need to do something further for the company to shut its investigation.

Pure Cycles determines the times customers are fertile by scanning their physique temperature and monitoring their menstrual cycle. It then marks their fertile days in pink, so that they’d know when to make use of further safety. Because it’s the primary app to be licensed for contraceptive use, it does not come as a shock that it is being scrutinized from each angle. To date, although, issues appear to be going effectively for the corporate: the FDA even lately granted it advertising approval within the US.

Pure Cycles chief Raoul Scherwitzl mentioned:

“We’re happy that the MPA has concluded its investigation, following a assessment of our real-world effectiveness knowledge. There was loads of dialogue about this investigation, and we hope that it’ll present some reassurance to girls to see eminent our bodies just like the Swedish MPA and the US FDA in alignment primarily based on the energy of our medical proof. We by no means doubted the effectiveness of our product because the variety of reported pregnancies is monitored intently on a month-to-month foundation – that is an ongoing accountability that we decide to as a part of working in a regulated surroundings.”



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