FDA

FDA Warns: Understand the Risks Before Using Z-Drugs for Insomnia

A new consumer update issued by the FDA cautions against the risks of complex sleep behaviors associated with prescription medications for insomnia, sometimes known as “Z-drugs.”

FDA

FDA Clears Forehead-Worn Home Sleep Test

The device, which adheres to a patient's forehead to collect physiological data, previously received regulatory clearance in Australia, New Zealand, and the European Union.

FDA

FDA: Philips CPAP Recall Testing Inadequate to Fully Evaluate Risks

The FDA has requested Philips conduct additional testing on its recalled CPAP, BiPAP, and ventilator devices, calling testing to date inadequate to fully evaluate the risks posed to users.

FDA Clears Pulse Oximeter Ring

Sep 7, 2023 | FDA, Race/Ethnicity, Remote Monitoring

The ring is able to accurately measure blood oxygen levels in people with any skin tone, according to a release from the company.

Harmony Gets FDA Orphan Drug Designation for Pitolisant for Idiopathic Hypersomnia

Sep 7, 2023 | Emerging Compounds, FDA, Idiopathic Hypersomnia

Harmony Biosciences is currently evaluating the efficacy and safety of pitolisant in adult patients with idiopathic hypersomnia in a phase 3 study, with topline results anticipated in the fourth quarter.

Incannex to Begin Investigational New Drug Opening Trial of IHL-42X in OSA

Aug 22, 2023 | Emerging Compounds, FDA, Obstructive Sleep Apnea

Incannex received approval from the US Food and Drug Administration for an Investigational New Drug opening pivotal IHL-42X phase 2/3 clinical trial in the United States as planned.

Low-Sodium Xywav Leads Jazz Pharma’s Oxybate Revenues

Aug 11, 2023 | Emerging Compounds, FDA, Idiopathic Hypersomnia, Narcolepsy, Prescription Drugs

During the second quarter, Jazz Pharmaceuticals registered a 39% year-over-year growth in net product sales of its low-sodium Xywav.

Nyxoah Speeds Pre-Commercialization as Neurostimulator Trial Progresses

Aug 9, 2023 | Emerging Technology, FDA, Neurostimulators, Obstructive Sleep Apnea

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.

Consumer Sleep-Tracking Ring’s Pulse Oximeter Under FDA Review for Clinical Use

Aug 4, 2023 | FDA, Sex, Wearable Sleep Trackers

The 510(k) application covers Evie Ring’s pulse oximeter which includes heart rate and blood oxygen saturation data and is expected to make it one of the first consumer wearables that is also cleared for clinical use.

FDA, DEA Urge Fix for Shortage of Stimulants, a Drug Class Used to Treat Narcolepsy

Aug 3, 2023 | FDA, Narcolepsy, Prescription Drugs

The agencies issued a joint statement updating the public on ongoing actions being taken to resolve the shortage of prescription stimulants, a drug class often used to treat narcolepsy.

Series of Regulatory Developments Define Inspire’s Q2 Landscape

Aug 2, 2023 | FDA, Neurostimulators, Obstructive Sleep Apnea

Inspire Medical Systems Inc reported second-quarter business results, marked by a series of US Food and Drug Administration regulatory approvals and submissions.

Incannex Submits IND for IHL-42X for Sleep Apnea

Jul 21, 2023 | Emerging Compounds, FDA, Obstructive Sleep Apnea

The IND application details the clinical trial protocol for the IND opening clinical trial, which is a multi-site phase 2/3 trial investigating IHL-42X, a cannabinoid combination product, for the treatment of OSA.

FDA Clears Somnics’ Pressure Titration Capability for Sleep Therapy Device

Jun 28, 2023 | FDA, Obstructive Sleep Apnea, Therapy Devices

Physicians will now have the ability to adjust the negative pressure settings of the iNAP sleep therapy device between -27 cmH2O and -122 cmH2O.

40 More Deaths Reported in Philips Recall

Jun 2, 2023 | CPAP & PAP Devices, FDA, Sleep Safety

The FDA updated its Philips Respironics recall safety communication to provide updated information about medical device reports that the agency received from Jan 1 to March 31.

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.