FDA

KemPharm Gets FDA Orphan Drug Designation for Serdexmethylphenidate for Idiopathic Hypersomnia

The drug developer expects to initiate a phase 2 clinical trial in patients with idiopathic hypersomnia before year-end 2022 and a second trial in patients with narcolepsy in 2023.

FDA

FDA Approves Expanded, Full-Body MRI Compatibility with Inspire Therapy

This full-body MRI approval expands the Inspire use labeling that previously allowed only head, neck, and extremity MRI scans.

FDA

New Sleep Products for 2021

A roundup of recent US Food and Drug Administration (FDA) clearances and approvals during the past year. The list covers sleep-related products, software, and services.

FDA Orders Philips Respironics to Notify Patients of Recall for CPAP Devices, Ventilators

Mar 11, 2022 | CPAP & PAP Devices, FDA

“The FDA has determined that this order is necessary to eliminate the unreasonable risk of harm posed by the recalled products, because the company’s notification efforts to date have been inadequate,” the agency wrote in a news alert.

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.

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

Jul 25, 2021 | CPAP & PAP Devices, FDA, Sleep Safety

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

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.

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