FDA

Beware of Compounded Tirzepatide

Tirzepatide copycats have implications for the safety of patients seeking treatment for obesity and obstructive sleep apnea.

FDA

FDA Clears EEG Brain Monitoring Headset

The headset is cleared for electroencephalography brain monitoring across hospital, home, ambulance, and air transport environments.

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.

Congressional Watchdog Will Launch Inquiry Into FDA Oversight of Medical Device Recalls

Jan 17, 2024 | FDA

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.

FDA: ResMed Recall for CPAP Masks With Magnets Classified as Class I

Jan 11, 2024 | FDA

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.

Surge in Overheating Reports Triggers FDA Alert on Philips DreamStation 2

Nov 28, 2023 | CPAP & PAP Devices, FDA

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.

FDA Addresses Racial Bias in Pulse Oximetry in Upcoming Meeting

Nov 17, 2023 | FDA

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.

New FDA Committee to Weigh in on Digital Health Technologies

Oct 11, 2023 | AI & Machine Learning, Big Data, FDA, Remote Monitoring, Telemedicine, Wearable Sleep Trackers

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.

Philips Agrees to FDA’s Call for More Testing on Recalled CPAP Devices

Oct 6, 2023 | CPAP & PAP Devices, FDA, Sleep Safety

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.

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.

Category: FDA

FDA

FDA

FDA