FDA Greenlights Phase 1 Trial of Narcolepsy Drug Candidate ORX750
The clinical trial will evaluate the safety, tolerability, and pharmacokinetics of Centessa Pharmaceuticals’ orexin receptor 2 agonist.
The clinical trial will evaluate the safety, tolerability, and pharmacokinetics of Centessa Pharmaceuticals’ orexin receptor 2 agonist.
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.”
The FDA has granted a De Novo authorization to a smartwatch developer for an over-the-counter feature to provide a notification of the risk of sleep apnea in users who have not been previously diagnosed.
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.
Read MoreAs Philips reassured patients that millions of recalled machines were safe, internal emails show federal regulators privately told the company its testing didn’t account for the impact of long-term harm from tainted devices.
Read MoreVanda received notification from the FDA regarding deficiencies in its supplemental new drug application for Hetlioz in treating insomnia.
Read MoreThe FDA provided an update on medical device reports, including reports of new deaths, that the agency received relating to Philips’ recall from July 1 to Sept 30, 2023.
Read MoreThe FDA is required to resolve Vanda Pharmaceuticals’ jet lag hearing request by March 5, following legal action from Vanda for unlawfully delaying a hearing.
Read MoreThe FDA is in the process of reviewing the company’s premarket notification for its ProSomnus EVO oral device for the treatment of patients with severe obstructive sleep apnea.
Read MoreThe device uses a molding method of being place in hot water to create a customizable fit for the user.
Read MoreCongressional 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.
Read MoreThe 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.
Read MoreVivos announced it is seeing positive preliminary metrics after receiving FDA clearance for its CARE oral appliances to treat severe OSA.
Read MoreFollowing warnings that CPAP masks with magnetic closures may interfere with certain medical devices and implants, sleep physicians have questions. Here’s what to know.
Read MoreThe FDA’s complaint-tracking system for medical devices allowed Philips to obscure when it knew about dangerous CPAPs, according to a new report from ProPublica.
Read MoreThe 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.
Read MoreThe FDA clearance expands the indications for the watch in the US as a medical device for use by adults in hospitals, clinics, long-term care facilities, and in the home.
Read MoreThe 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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