FDA

Incannex Meets with FDA in Pre-IND Meeting for Sleep Apnea Drug Candidate

Incannex characterized the pre-investigational new drug application (pre-IND) meeting about IHL-42X as “highly constructive.”

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: Philips Recall Is ‘Most Serious Type of Recall’

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

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.

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.

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.

Category: FDA

FDA

FDA

FDA