FDA

FDA Clears Withings ScanWatch for SpO2 Functionality: CEO Says Wearable ‘Can Aid in the Detection of Breathing Disturbances at Night’

Developed with cardiologists and sleep experts, it has been used in a study to monitor COVID patients remotely in German hospitals.

FDA

FDA Approves Next-Gen Remedē System for Central Sleep Apnea

The remedē EL-X System features enhanced functionality, simplifies the implant procedure, and provides greater device longevity.

FDA

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

It is anticipated that the study will begin enrolling subjects in the next 6 weeks and will be conducted at 10 sites.

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

Jun 25, 2021 | FDA, Narcolepsy, Prescription Drugs

The FDA also published its summary of clinical superiority findings for Xywav for the treatment of cataplexy or excessive daytime sleepiness associated with narcolepsy.

FDA Issues Melatonin Supplement Recall

Apr 23, 2021 | FDA

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

FDA: Patients with Nyxoah Implant OK to Undergo MRI

Feb 10, 2021 | Emerging Technology, FDA, Neurostimulators, Obstructive Sleep Apnea

This revised labeling ensures that patients who receive the Genio system and those already implanted can now undergo full-body 1.5T and 3T MRI diagnostic scans within approved parameters.

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

Feb 2, 2021 | FDA, Sleep Diagnostics, Sleep Treatments

It’s been an unusual year. But, mostly as usual, the US Food & Drug Administration continued to review device and drug applications across all fields of medicine.

FDA Clears New Bilevel by 3B Medical

Feb 1, 2021 | CPAP & PAP Devices, FDA

The Luna G3 Auto BPAP is available with integrated heated tubing, cellular connectivity, and an algorithm that auto-adjusts pressure settings.

SOMNOmedics PSGs Now FDA Approved for Pediatric Use

Jan 14, 2021 | Age, FDA, In-Lab Tests

The FDA approval is for children as young as 2 years old. Specific analysis templates for children are available in DOMINO software.

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.

Category: FDA

FDA

FDA Clears Withings ScanWatch for SpO2 Functionality: CEO Says Wearable ‘Can Aid in the Detection of Breathing Disturbances at Night’

Connecticut Attorney General Urges FDA to Expedite Philips CPAP Replacement

Will Nanosensors in Clothing Monitor Sleep Apnea in the Future?

FDA Updates FAQs on Philips Recall

FDA Grants Breakthrough Designation for Nyxoah Genio System for Obstructive Sleep Apnea & Complete Concentric Collapse

Philips Starts Repair & Replacement Program of First-Gen DreamStation Devices in United States

FDA Approves First-Ever Treatment for Idiopathic Hypersomnia

FDA

FDA Approves Next-Gen Remedē System for Central Sleep Apnea

FAQs on the Philips CPAP, BiPAP, and Ventilator Recall

FDA Grants Breakthrough Therapy Designation to Takeda’s Investigational Oral Orexin Agonist for Narcolepsy Type 1

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