FDA Clears Zeto New Wave for Outpatient Routine EEG
The EEG system features a 21-electrode setup and cloud connectivity to help clinics address staffing shortages and expand access to neurodiagnostics.
Category: FDA
FDA
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FDA
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Beware of Compounded Tirzepatide
Tirzepatide copycats have implications for the safety of patients seeking treatment for obesity and obstructive sleep apnea.
FDA
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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.
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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New FDA Committee to Weigh in on Digital Health Technologies
The US Food and Drug Administration has created a new Digital Health Advisory Committee to help the agency explore the complex, scientific, and technical issues related to digital health technologies.
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Philips Agrees to FDA’s Call for More Testing on Recalled CPAP Devices
Philips Respironics says it plans to conduct additional testing on certain CPAP and respiratory devices involved in its June 2021 recall at the request of the FDA.
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FDA Clears Pulse Oximeter Ring
The ring is able to accurately measure blood oxygen levels in people with any skin tone, according to a release from the company.
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Harmony Gets FDA Orphan Drug Designation for Pitolisant for 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.
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