FDA

FDA: Philips Recall Is ‘Most Serious Type of Recall’

"Use of these devices may cause serious injuries or death," the FDA now says.

FDA

FDA Issues Melatonin Supplement Recall

A popular vitamin brand recalled some of its gummy products because they could contain metal.

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.

FDA Clears ProSomnus EVO Oral Appliance

Dec 16, 2020 | FDA, Obstructive Sleep Apnea, Oral Appliances

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

FDA: MATRx Plus Sleep Theragnostic Test OK Without Nasal Cannula

Dec 14, 2020 | FDA, Home Apnea Testing, Oral Appliances

This change to Zephyr Sleep Technology’s MATRx plus makes setting up the take-home sleep appliance treatment planning test simpler for the patient and easier for the dental team to dispense.

‘PortPatch’ CPAP Filter Gets FDA Emergency Use Authorization

Dec 9, 2020 | CPAP & PAP Devices, FDA

Made of N99-rated filter material, the patent-pending PortPatch is intended to reduce the spread of airborne particulates.

3B Lumin, Originally Designed for CPAP Accessories, Gets FDA Emergency Use Authorization for N95 Mask Re-Use

Dec 3, 2020 | FDA

The decision allows Lumin to be used by healthcare workers employed in nursing homes, long term acute care, ambulatory, primary care, and clinics to allow N95 re-use to stop the spread of COVID-19.

FDA Approves HETLIOZ for Sleep Disturbances in Smith-Magenis Syndrome

Dec 1, 2020 | FDA, Prescription Drugs

Smith-Magenis Syndrome is a rare neurodevelopmental disorder, a defining feature of which is an “inverted” circadian rhythm.

Expanded WAKIX Label Could ‘Help Even More People Living with Narcolepsy’

Nov 24, 2020 | FDA, Narcolepsy, Prescription Drugs

The FDA says that Harmony Biosciences’ drug—previously approved for excessive daytime sleepiness in narcolepsy—works for cataplexy too. Harmony’s chief medical officer explains how this impacts healthcare practitioners and patients.

Sommetrics Gets FDA Breakthrough Designation for AerSleep II for Sleep Apnea

Nov 20, 2020 | Emerging Technology, FDA, Obstructive Sleep Apnea

AerSleep II applies negative pressure over the external surface of the neck to hold the airway open. It is self-contained with an integral vacuum pump.

FDA Grants NightWare’s De Novo Application to Treat Nightmares in PTSD

Nov 9, 2020 | FDA, REM Parasomnias, Therapy Devices

The device provides gentle vibration through touch based on an analysis of heart rate and motion during sleep.

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.

Category: FDA

FDA

FDA: Philips Recall Is ‘Most Serious Type of Recall’

New EnsoSleep FDA Clearance Includes Total Sleep Time for Home Sleep Tests & Pediatric Scoring

FDA Publishes Consumer Update on Sleep Apnea

FDA Issues Safety Communication About Philips Recall

FDA Gives LivaNova Approval for Aura6000 Clinical Study for Obstructive Sleep Apnea

FDA Grants Orphan Drug Status to Xywav, Citing “Greatly Reduced Chronic Sodium Burden Compared to Xyrem”

Sommetrics Gets FDA OK for Pivotal In-Home Clinical Trial of AerSleep II

FDA