FDA

FDA Clears HoneyNaps’ AI-Powered Sleep-Scoring Software

The software leverages deep learning-based AI to perform real-time analysis of vast volumes of multi-channel/time series biosignals to quickly deliver diagnostic information.

FDA

Nyxoah Speeds Pre-Commercialization as Neurostimulator Trial Progresses

Nyxoah announced operating results for the second quarter and first half of 2023, emphasizing advances in its investigational device exemption trial designed to support the marketing authorization of the Genio neurostimulator system for the treatment of OSA.

FDA

FDA Approves Once-Nightly Treatment for Narcolepsy

The approval of the extended-release formulation of sodium oxybate allows for uninterrupted sleep and full treatment benefits in a single bedtime dose for people with narcolepsy.

FDA Updates Warnings for Class of Drugs Used to Treat Narcolepsy

May 16, 2023 | FDA, Narcolepsy, Prescription Drugs

The FDA says current prescribing information for some prescription stimulants does not provide up-to-date warnings about the harms of misuse and abuse.

MCRA Helps Noctrix Secure Marketing Authorization for RLS Therapy Device

May 8, 2023 | FDA, Restless Legs Syndrome, Restless Legs Syndrome Devices

The device is indicated to reduce symptoms of primary moderate-severe restless legs syndrome and improve sleep quality in adults refractory to medications.

Philips CEO: Resolving Recall Remains ‘Our Highest Priority’

Apr 24, 2023 | CPAP & PAP Devices, FDA, Sleep Safety

Philips provides an update on field action for specific sleep therapy and ventilator devices involved in the company’s ongoing recall.

Zevra Seeks FDA Authorization to Investigate KP1077 for Narcolepsy

Apr 4, 2023 | Emerging Compounds, FDA, Narcolepsy

KP1077 is currently being evaluated in a phase 2 clinical trial for the treatment of idiopathic hypersomnia.

Infant Supine Sleep System Gets FDA De Novo Approval

Apr 3, 2023 | FDA, Sleep Safety

The baby bed is designed to keep sleeping babies positioned on the back—a position known to lower the risk of sudden infant death syndrome.

FDA Authorizes Importation of Tentatively-Approved Narcolepsy Drug

Mar 22, 2023 | Emerging Compounds, FDA, Narcolepsy

The authorization allows the company to shorten the time to product availability following an anticipated final approval decision from the FDA.

FDA Looks Into Dental Device After KHN-CBS News Investigation of Patient Harm

Mar 16, 2023 | FDA, Mouth & Upper Airway, Therapy Devices

In the wake of an investigation into a dental appliance that multiple lawsuits allege caused grievous harm to patients, the FDA has begun looking into the product, the Anterior Growth Guidance Appliance, according to a former agency official.

FDA Clears Wearable Ring to Detect Sleep Apnea

Mar 13, 2023 | FDA, Home Apnea Testing, Obstructive Sleep Apnea

The company, which received FDA clearance for its first-generation ring in 2018, says the sleep system could potentially speed up OSA diagnosis for nearly 1 billion people worldwide.

Avadel Seeks Final FDA Approval for Lumryz to Treat Narcolepsy

Mar 3, 2023 | Emerging Compounds, FDA, Narcolepsy

If approved, Avadel expects once-at-bedtime Lumryz to be the treatment of choice for patients with narcolepsy-related excessive daytime sleepiness or cataplexy.

Philips Recall: 82 More Death Reports in Medical Device Reports

Feb 15, 2023 | CPAP & PAP Devices, FDA, Sleep Safety

The FDA updated its Philips Respironics recall safety communication this month to provide updated information about medical device reports received from November 1, 2022, to December 31, 2022.

FDA Clears Mandibular Jaw Movement-Based Home Sleep Test

Feb 13, 2023 | FDA, Home Apnea Testing

The FDA has cleared a new home sleep test, which uses a novel way to measure sleep—jaw movements—alongside the traditional signals of airflow and oximetry.

KemPharm Gets FDA Orphan Drug Designation for Serdexmethylphenidate for Idiopathic Hypersomnia

Jan 3, 2023 | Emerging Compounds, FDA, 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.

91 More Reports of Death in Philips Recall-Related Reporting

Nov 30, 2022 | CPAP & PAP Devices, FDA

The FDA updated its safety communication on the Philips’ recall to include reporting of medical device reports received from August 1 to October 31, 2022.

Philips Recalls Specific CPAP, BiPAP Masks with Magnets

Sep 6, 2022 | CPAP & PAP Devices, FDA

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

Additional Recall for Certain Philips BiPAP Devices

Aug 30, 2022 | CPAP & PAP Devices, FDA

Philips Respironics recalls more devices but the BiPAP recall is unrelated to the PE-PUR foam issue.

Category: FDA

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