Health
Clues Get FDA Approval for Digital Contraception
The most well-known clues in the menstrual tracking app, Presentation this thing Received clearance The Digital Contraceptive feature from the Food and Drug Administration states that it helps users prevent pregnancy based only on the start date of their period. Based on statistical modeling, calculate the windows in which someone may become pregnant.
“It’s personalized over time, so when an individual enters the first day cycle, they can personalize the high-risk and low-risk day windows,” said Crew Chief Medical Officer. Renaive Rayboy says. Said TechCrunch..
The company plans to launch digital contraceptives later this year.
The clue is that its digital contraception is 92% effective in preventing unwanted pregnancies when used as most people do (explaining some errors) and 97% effective in full use. Say that.The statistical method it used is Originally developed Tested by researchers at Georgetown University’s Reproductive Health Institute and a company called Cycle Technologies, it was acquired by Clue in 2019.
This is the second form of digital contraceptive method to get permission from the FDA to sell as a contraceptive. In the first Natural Cycles, users need to measure their temperature every morning. Clearance in 2018 was controversial — came shortly after the app was blamed Unwanted pregnancy in Sweden..
Digital contraception for clues has been approved by the FDA under the designation of “substantially equivalent.” In short, the FDA has determined that it is safe and effective because it resembles a product already on the market. In this case, Clue’s product was considered sufficiently similar to Natural Cycles. Elina Berglund, CEO of Natural Cycles, said in a statement that the company will conduct its own analysis of clues. “The first findings based on the FDA’s submission show that there is a significant difference between Natural Cycles and other products. This product is based solely on menstrual data and other biomarkers such as temperature. Is not included, “she said.
The idea behind digital contraception is related to contraceptive fertility treatments, where people track indicators such as menstrual dates. Their temperature, And alter the cervical mucus to predict when ovulation may occur and pregnancy may occur.These methods Very effective Proper use usually requires rigorous, hands-on tracking.A good option for those who cannot or do not want to use hormonal contraceptives or other methods, but some experts say Worry about the principle It cannot be translated into an app.
Only people between the ages of 18 and 45 who have regular periods should use Clue’s contraceptives. Said TechCrunch.. If someone is ineligible or their cycle becomes too irregular, the app keeps them out, CEO Audrey Tsang said.
Clue’s menstrual tracker previously had the ability to predict whether a user would be in a fertile time zone, such as the day and day before ovulation.The app said a fertile window feature Do not use as a contraceptive But, Trying to get pregnant..The company has removed that feature last week, Says it may be inaccurate. “We have determined that it can be misleading for those who want to use fertile windows to avoid pregnancy,” it said. Blog post.. “We would like to provide a solution to this problem in the near future.”
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