FDA Policy/General

Product Approval Summaries

DEVICES

FDA has cleared an EnsoData 510(k) for EnsoSleep, a software-only medical device used under the supervision of clinicians to analyze physiological signals and automatically score sleep study results. EnsoSleep is intended for use for the diagnostic evaluation by physicians to assess sleep quality and as an aid in diagnosing adult sleep and respiratory-related sleep disorders, according to the company.

FDA has cleared an Advanced Cooling Therapy 510(k) for use of its Esophageal Cooling Device (ECD) with the Altrix Precision Temperature Management System by Stryker. The ECD is designed to modulate and control patient temperature when clinically indicated through a single use, fully-enclosed triple lumen system that is inserted into the esophagus, according to the company.

FDA has cleared a United Orthopedic 510(k) for its E-XPE polyethylene knee insert that is designed to provide patients with knee replacements with reduced risk of oxidation. The device is made of “highly cross-linked polyethylene blended with 0.1% (w/w) vitamin E to enhance wear resistance without compromising oxidative stability and mechanical properties,” according to the company.

DRUGS

FDA has approved a Neurocrine Biosciences NDA for Ingrezza (valbenazine) capsules to treat adults with tardive dyskinesia, a neurological disorder characterized by repetitive involuntary movements of the jaw, lips and tongue. The disorder is a serious side effect associated with patients who have been treated with antipsychotic medications, especially the older medications, for long periods to treat chronic conditions, such as schizophrenia and bipolar disorder.

FDA has approved two Gilead Sciences supplemental NDAs for Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir) to treat hepatitis C virus (HCV) in children ages 12 to 17. Previously, the therapies were approved to treat HCV in adults.

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