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# Product Approval Summaries
- URL: https://www.fdaweb.com/product-approval-summaries-26/
- Published: 2021-11-14T12:00:00.000Z
- Updated: 2026-09-14T17:22:17.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5142098

**DEVICES**

FDA has granted de novo marketing for **Natural Cycles** Nordic’s Natural Cycles mobile medical application that can be used as a method of contraception to prevent pregnancy. The app contains an algorithm that calculates the days of the month a woman is likely to be fertile based on daily body temperature readings and menstrual cycle information, a contraceptive method called fertility awareness. Designed for mobile devices, it is intended for use in pre-menopausal women aged 18 and older.

FDA has cleared an **Aidoc** artificial intelligence solution for radiologists to flag acute intracranial hemorrhage cases in head computed tomography scans. Aidoc’s solution analyzes medical images directly after a patient is scanned and notifies the radiologist of suspected hemorrhage cases to assist with prioritization of potentially life-threatening cases, according to the company. Already marketed outside of the U.S., the device is also under review for the remainder of its solutions to assist in the detecting a broad set of acute pathologies across the body, it says.

**DRUGS**

FDA has approved a **Population Council** NDA for Annovera (segesterone acetate and ethinyl estradiol vaginal system), the first vaginal ring contraceptive that can be used for an entire year. The reusable donut-shaped, non-biodegradable, flexible vaginal system is placed in the vagina for three weeks followed by one week out of the vagina, at which time women may experience a period (a withdrawal bleed), [according to the agency](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm616541.htm?ref=fdaweb.com). The schedule is repeated every four weeks for one year (thirteen 28-day menstrual cycles). The ring is washed and stored in a compact case for the seven days not in use.

FDA has approved an **Alnylam Pharmaceuticals** NDA for Onpattro (patisiran) infusion for treating peripheral nerve disease (polyneuropathy) caused by hereditary transthyretin-mediated amyloidosis in adult patients. This is the first FDA approval of a new class of drugs called small interfering ribonucleic acid (siRNA), which work by silencing a portion of RNA involved in causing the disease.