The U.S. Food and Drug Administration (FDA) announced it has recently approved a digital birth control app that will be marketed in the U.S. The latest app is named as Natural Cycles. The recently approved medical device is supposed to be the first of its kind that successfully received the FDA approval.
The app presents itself as a digital upgrade to the so-called rhythm technique that involves forecasting the course of the menstrual cycle depending on the woman’s menstrual history. The latest app is developed by Natural Choices, a Sweden-based company. The app employs an algorithm to predict the position of women in their monthly menstrual cycle. The algorithm’s predictions principally depend on small changes in daily temperature readings taken by users. The app marks days considered non-fertile in green color and days fertile in red color.
The FDA’s de novo premarket review pathway was utilized for clearing the latest app for marketing. The de novo premarket review is said to be the speedier review process for small to average-risk medical devices that offer a novel use to the public.
On a similar note, recently Ivantis proclaimed that the company has received the FDA approval for its Hydrus microstent. The latest microstent is intended for the treatment of patients suffering from mild to moderate open-angle glaucoma in combination with cataract surgery.
Dave Van Meter, President & CEO, Ivantis, proclaimed in the company press release that the firm aims to introduce the latest device later this year. The approval for the latest MIGS device was offered on basis of the HORIZON trial results. This trial involved about 556 patients with mild to moderate glaucoma. All these patients had undergone a cataract surgery. They were randomly assigned to get either cataract surgery plus the Hydrus microstent or a cataract surgery alone.