Natural Cycles app tracks a woman's fertile days and suggests when to use contrapection
The Annovera vaginal ring protects against pregnancy for one year
An app designed to track fertility and prevent pregnancy in women 18 and older is the first to win US Food and Drug Administration approval to be marketed as a contraceptive, the agency announced Friday. The Natural Cycles app was approved as part of the agency’s new Digital Health Innovation Action Plan, designed to fast track approval for new low-to-moderate-risk devices.
“This new app can provide an effective method of contraception if it’s used carefully and correctly,” said Dr. Terri Cornelison, assistant director for the health of women in the FDA’s Center for Devices and Radiological Health, in a statement. “But women should know that no form of contraception works perfectly, so an unplanned pregnancy could still result from correct usage of this device.”
Also Friday, the FDA announced approval of a vaginal ring designed by the global nonprofit research organization the Population Council. Called Annovera, the device is “the first vaginal ring contraceptive that can be used for an entire year,” the FDA said.
According to the Population Council, Annovera is the first in a new class of contraceptives. The soft reusable ring combines a new progestin (segesterone acetate) with a widely used estrogen (ethinyl estradiol) to develop a single product designed to be left in place for 21 days and removed for seven days.
“It is indicated to prevent pregnancy for up to a year and does not require refrigeration, which is particularly important for distribution and use in low-resource settings,” the Population Council said on its website. In partnership with the pharmaceutical company TherapeuticsMD, the council plans to offer the ring at significantly reduced prices to lower-income women at federally designated Title X family plan