FDA

Philips Recalls Specific CPAP, BiPAP Masks with Magnets

The FDA announced the recall of certain Philips Respironics CPAP and BiPAP masks due to a safety concern involving magnets.

FDA

Green Pharmaceuticals Recalls SnoreStop NasoSpray Lot

Camarillo, Calif-based Green Pharmaceuticals Inc is voluntarily recalling lot 2373/21222 of SnoreStop NasoSpray.

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’

Oct 18, 2021 | FDA, Wearable Sleep Trackers

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

Will Nanosensors in Clothing Monitor Sleep Apnea in the Future?

Sep 29, 2021 | AI & Machine Learning, FDA, Future of Sleep, Home Apnea Testing, Wearable Sleep Trackers

Nanowear’s SimpleSense uses its proprietary cloth-based smart nanosensor technology to capture and analyze these low-noise, 85+ biomarkers using time-synchronous scattering methods.

FAQs on the Philips CPAP, BiPAP, and Ventilator Recall

Jul 29, 2021 | CPAP & PAP Devices, FDA

The FDA has provided answers to frequently asked questions related to the Philips CPAP, BiPAP, and ventilator recall.

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

Jul 29, 2021 | Emerging Compounds, FDA, Narcolepsy

The designation was based, in part, on early phase and preliminary clinical data that indicates Takeda’s investigational oral orexin agonist may demonstrate substantially improved objective and subjective measurements of daytime wakefulness in NT1 patients.

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

Jul 15, 2021 | AI & Machine Learning, FDA

Originally cleared by the FDA in 2017, the update introduces additional sleep apnea subtyping and detection capabilities, including Cheyne-Stokes respiration, periodic breathing episodes, respiratory rate, and more.

FDA Publishes Consumer Update on Sleep Apnea

Jul 13, 2021 | FDA, Obstructive Sleep Apnea

FDA: Getting treatment for obstructive sleep apnea or OSA can save your life and help you feel better every day.

FDA Issues Safety Communication About Philips Recall

Jul 5, 2021 | CPAP & PAP Devices, FDA

Report any problems with a device through the FDA’s MedWatch Voluntary Reporting Form.

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.

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.

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

Apr 30, 2021 | FDA, Obstructive Sleep Apnea, Therapy Devices

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

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 Approves Inspire Medical’s New Physician Programmer Platform

Mar 31, 2021 | FDA, Neurostimulators, Obstructive Sleep Apnea

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

FDA Approves Inspire Implant Surgery That Eliminates 3rd Incision

Mar 21, 2021 | FDA, Neurostimulators, Obstructive Sleep Apnea

The procedure reduces the average procedure time for Inspire therapy by ~20% and minimize the risk of breast and chest wall injury.

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.

FDA Clears First Daytime Sleep Apnea Therapy

Feb 5, 2021 | FDA, Neurostimulators, Obstructive Sleep Apnea, Snoring

This is the first device used while awake that is intended to improve tongue muscle function, which can help prevent the tongue from collapsing backwards.

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