FDA

FDA to Philips: Safety Risks May Exist with the Replacement Foam for Recalled Devices

During the manufacturing facility inspection, the FDA obtained additional information regarding the silicone-based foam used in a device outside the United States that failed one safety test for the release of VOCs.

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

FDA Approves First-Ever Treatment for Idiopathic Hypersomnia

Xywav can be administered as a twice- or once-nightly regimen for the treatment of idiopathic hypersomnia in adults.

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 Gives LivaNova Approval for Aura6000 Clinical Study for Obstructive Sleep Apnea

Jun 29, 2021 | Emerging Technology, FDA, Neurostimulators, Obstructive Sleep Apnea

This randomized controlled trial will take place at approximately 20 sites across the United States and will enroll a maximum of 150 adult patients with moderate to severe OSA who do not achieve results from a traditional CPAP machine or have declined its use.

Category: FDA

FDA

FDA to Philips: Safety Risks May Exist with the Replacement Foam for Recalled Devices

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

FDA Approves First-Ever Treatment for Idiopathic Hypersomnia

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

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

FDA Approves Inspire Medical’s New Physician Programmer Platform

FDA Approves Inspire Implant Surgery That Eliminates 3rd Incision

FDA Clears First Daytime Sleep Apnea Therapy

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

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”

FDA Issues Melatonin Supplement Recall

FDA: Patients with Nyxoah Implant OK to Undergo MRI

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 Clears ProSomnus EVO Oral Appliance

FDA: MATRx Plus Sleep Theragnostic Test OK Without Nasal Cannula

‘PortPatch’ CPAP Filter Gets FDA Emergency Use Authorization

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

FDA Approves HETLIOZ for Sleep Disturbances in Smith-Magenis Syndrome

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

Sommetrics Gets FDA Breakthrough Designation for AerSleep II for Sleep Apnea

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