Participant Screening Begins for Phase 2 Study of Novel OSA Therapy
Incannex Healthcare has initiated screening for its DReAMzz dose confirmation study evaluating IHL-42X for obstructive sleep apnea.
Category: FDA
FDA
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FDA
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FDA Clears Nylon Oral Appliance with Single-Point Midline Advancement
The device, cleared for mild to moderate OSA, is available immediately. PDAC coverage is pending.
FDA
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FDA Clears OTC Pulse Oximeter Designed for Accuracy Across Skin Tones
The FDA has granted 510(k) clearance for an over-the-counter fingertip pulse oximeter designed to provide accurate blood oxygen readings across all skin tones.
Beacon Biosignals’ Dreem 3S Headband Can Now Evolve Faster with FDA-Cleared Plan
The FDA authorizes Beacon Biosignals’ Predetermined Change Control Plan for the Dreem 3S EEG headband, enabling continuous algorithm updates to advance sleep monitoring and clinical-grade EEG analytics.
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FDA Seeks Input on Advancing Health Equity in Medical Devices
The FDA’s Center for Devices and Radiological Health has released a discussion paper and is soliciting public feedback to enhance health equity in the context of medical devices.
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FDA Rejects Petition Challenging Safety of Narcolepsy Drug Wakix
The FDA maintains its approval for the narcolepsy treatment in adults and recently expanded use in pediatric patients.
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FDA Clears EEG Brain Monitoring Headset
The headset is cleared for electroencephalography brain monitoring across hospital, home, ambulance, and air transport environments.
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Video Analysis Sleep Monitoring Solution Receives FDA Clearance and CE Mark
The software-only medical device uses video analysis to assess patient movement, activity, and physiological signs in inpatient settings.
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New FDA Guidance Defines ‘Remanufacturing’ for Medical Devices Needing Repair
The FDA has issued final guidance to clarify the definition of “remanufacturing” for reusable medical devices needing maintenance or repair.
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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.”
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FDA Grants Orphan Drug Designation to Pitolisant in Prader-Willi Syndrome
The US Food and Drug Administration (FDA) has granted Orphan Drug designation to Harmony...
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FDA Clears EnsoData’s AI Technology for Sleep Diagnosis with Pulse Oximetry
The clearance will allow EnsoData’s artificial intelligence to support the diagnosis of sleep disorders using any FDA-cleared pulse oximeter.
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FDA Clears Fingertip Pulse Oximeter for Over-the-Counter Use
The FDA has granted clearance for an over-the-counter fingertip pulse oximeter, featuring technology widely used in hospitals and clinics that demonstrates consistent accuracy across different skin tones.
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FDA Flags Deficiencies in Vanda’s Insomnia sNDA
Vanda received notification from the FDA regarding deficiencies in its supplemental new drug application for Hetlioz in treating insomnia.
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Congressional Watchdog Will Launch Inquiry Into FDA Oversight of Medical Device Recalls
Congressional investigators are launching an inquiry into the FDA’s oversight of medical device recalls following reports that the agency failed to issue warnings about breathing machines capable of sending hazardous particles and fumes into the lungs of patients.
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FDA: ResMed Recall for CPAP Masks With Magnets Classified as Class I
The FDA has identified ResMed’s recall of over 20 million AirFit and AirTouch CPAP masks with magnets as a Class I recall, the most serious type of recall. There have been six reported injuries.
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Surge in Overheating Reports Triggers FDA Alert on Philips DreamStation 2
The FDA is warning patients and health care providers to carefully monitor Philips DreamStation 2 CPAP machines for signs of overheating after receiving an increase in reports.
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FDA Addresses Racial Bias in Pulse Oximetry in Upcoming Meeting
The FDA’s Feb 2 virtual public meeting will focus on new methods for evaluating pulse oximeter accuracy, addressing variations in skin pigments and racial/ethnic groups.
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