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# Product Approval Summaries
- URL: https://www.fdaweb.com/product-approval-summaries-76/
- Published: 2018-12-09T12:00:00.000Z
- Updated: 2026-09-15T00:49:36.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5138464

**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.