FDA

FDA Approves Inspire Medical’s New Physician Programmer Platform

A new telemetry cable enables Bluetooth connectivity to the programmer tablet. The platform interfaces with Inspire Cloud.

FDA

FDA Clears ProSomnus EVO Oral Appliance

EVO is the first oral appliance to use ProSomnus' MG6 technology, which combines high-performance medical-grade materials, manufacturing robotics, and AI.

FDA

FDA Preliminary Lab Tests: Several CPAP Cleaners Generate Ambient Levels of Ozone Above Safe Limits [Video]

The FDA issued a Safety Communication to inform patients and health care providers that devices claiming to clean, disinfect, or sanitize continuous positive airway pressure (CPAP) devices or accessories (such as masks, tubing, headgear) using ozone gas or ultraviolet (UV) light are not legally marketed for this use by the FDA in the United States, and as such, their safety and effectiveness for use with CPAP devices and accessories is unknown.

WAKIX Gets Additional FDA Approval—for Cataplexy

Oct 14, 2020 | FDA, Narcolepsy, Prescription Drugs

FDA approval of WAKIX for the treatment of cataplexy in adult patients with narcolepsy is based on two randomized, controlled trials.

FDA Fast Tracks Xywav for Idiopathic Hypersomnia

Oct 8, 2020 | Emerging Compounds, FDA, Idiopathic Hypersomnia

“There is significant need for greater awareness of idiopathic hypersomnia, which can severely impact a person’s daily life, and can often be misdiagnosed or undiagnosed over a substantial period of time.”

FDA Requires Label Changes for Benzos

Sep 23, 2020 | FDA, Insomnia, Prescription Drugs

Benzodiazepines are ‘commonly abused and misused, often together with opioid pain relievers and other medicines, alcohol, and illicit drugs.’

FDA Grants Priority Review Vanda’s for Melatonin Receptor Agonist HETLIOZ (Tasimelteon) for Smith-Magenis Syndrome

Aug 3, 2020 | Emerging Compounds, FDA

HETLIOZ (tasimelteon) improved sleep quality and increased sleep duration in patients with Smith-Magenis Syndrome in a placebo-controlled clinical study.

Combo CPAP/Filter Mask by Circadiance Gets FDA Emergency Use Authorization

Jul 22, 2020 | CPAP & PAP Devices, FDA

The product is a CPAP mask that was modified by combining it with an N95.

Wearable Restless Legs Syndrome Therapy Granted FDA Breakthrough Device Designation

Jun 3, 2020 | Emerging Technology, FDA, Restless Legs Syndrome

Noctrix Health aims to treat RLS symptoms with its wearable neuromodulation platform that targets specific peripheral nerve fibers in a manner that is comfortable to wear to sleep.

These Sleep Medicine Products Got FDA Nod in 2019

May 14, 2020 | FDA, Sleep Diagnostics, Sleep Treatments

Sleep Review annually rounds up the sleep medicine devices, pharmaceuticals, and more that earned US Food and Drug Administration clearance.

Somnetics Gets FDA Emergency Use Authorization for BiPAPs and Respiratory Circuits

May 13, 2020 | CPAP & PAP Devices, FDA

The Minnesota-based CPAP manufacturer is supporting local and regional medical communities with an emergency supply of EUA BiPAP devices purchased by the state of Minnesota and South Dakota medical facilities.

Vanda to Resubmit FDA Application for HETLIOZ for Sleep Disturbance in Patients with Smith-Magenis Syndrome

May 13, 2020 | FDA, Pharmaceuticals

Vanda Pharmaceuticals Inc has completed a Type A Meeting with the US Food and Drug Administration (FDA) on May 8, 2020, it has reached agreement with the FDA to resubmit its application for HETLIOZ (tasimelteon) for the treatment of Smith-Magenis Syndrome.

FDA: CPAPs May be Used to Support Patients with Respiratory Insufficiency During the Coronavirus Disease 2019 Outbreak

Mar 26, 2020 | FDA

In a letter to health care providers dated March 20, the US Food and Drug Administration advises the following.

FDA Warning Letter: EPAP Mask Maker Is Misbranding Its Snoring Device

Mar 4, 2020 | FDA, Snoring

CPAPNEA Medical Supply has a cleared 510(k) for the Optipillows EPAP mask for the sole intended use of alleviating snoring during sleep in adults, states the FDA in a warning letter.Your device is misbranded under section...

Prescribing Info Update: BELSOMRA Improves Total Sleep Time, WASO in Study of Mild-to-Moderate Alzheimer’s Disease Patients

Feb 3, 2020 | FDA, Insomnia, Prescription Drugs

Merck has received approval from the U.S. Food and Drug Administration (FDA) for an update to the...

Public Notification: U-Dream Full Night Contains Hidden Drug Ingredient

Jan 3, 2020 | FDA, Over-the-Counter Treatments

The Food and Drug Administration (FDA) is advising consumers not to purchase or use U-Dream Full Night, a product promoted and sold as a sleep aid on various websites, as an FDA aboratory analysis confirmed that U-Dream...

FDA Warns of Serious Breathing Problems with Gabapentinoids When Used with CNS Depressants or in Patients with Lung Problems

Dec 23, 2019 | FDA, Pharmaceuticals, Prescription Drugs, Restless Legs Syndrome

An FDA-approved drug for restless legs syndrome is included. The US Food and Drug Administration...

FDA Responds to Citizen Petitions Requesting Black Box Warnings on Dopamine Agonists for Restless Legs Syndrome

Nov 22, 2019 | FDA, Prescription Drugs, Restless Legs Syndrome

In a 39-page letter dated October 21, 2019, the US Food and Drug Administration (FDA) responded to...

Category: FDA

FDA

FDA Approves Inspire Medical’s New Physician Programmer Platform

FDA Approves Inspire Implant Surgery That Eliminates 3rd Incision

FDA: Patients with Nyxoah Implant OK to Undergo MRI

FDA Clears First Daytime Sleep Apnea Therapy

2020 Roundup: The Year in FDA Clearances & Approvals for Sleep Medicine

FDA Clears New Bilevel by 3B Medical

SOMNOmedics PSGs Now FDA Approved for Pediatric Use

FDA