FDA Policy/General

Product Approval Summaries

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. 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.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome