SOMNOmedics PSGs Now FDA Approved for Pediatric Use
The FDA approval is for children as young as 2 years old. Specific analysis templates for children are available in DOMINO software.
The FDA approval is for children as young as 2 years old. Specific analysis templates for children are available in DOMINO software.
AerSleep II applies negative pressure over the external surface of the neck to hold the airway open. It is self-contained with an integral vacuum pump.
Mylan NV on June 1 announced the US launch of Armodafinil tablets, 50 mg, 150 mg, 250 mg, a generic version of Cephalon’s Nuvigil. Mylan received final approval from the Food and Drug Administration (FDA) for its...
Sleep Review annually rounds up the sleep medicine devices, pharmaceuticals, and more that earned US Food and Drug Administration clearance.
Read MoreThe Minnesota-based CPAP manufacturer is supporting local and regional medical communities with an emergency supply of EUA BiPAP devices purchased by the state of Minnesota and South Dakota medical facilities.
Read MoreVanda Pharmaceuticals Inc has completed a Type A Meeting with the US Food and Drug Administration (FDA) on May 8, 2020, it has reached agreement with the FDA to resubmit its application for HETLIOZ (tasimelteon) for the treatment of Smith-Magenis Syndrome.
Read MoreIn a letter to health care providers dated March 20, the US Food and Drug Administration advises the following.
Read MoreCPAPNEA Medical Supply has a cleared 510(k) for the Optipillows EPAP mask for the sole intended use of alleviating snoring during sleep in adults, states the FDA in a warning letter.Your device is misbranded under section...
Read MoreThe FDA issued a Safety Communication to inform patients and health care providers that devices claiming to clean, disinfect, or sanitize continuous positive airway pressure (CPAP) devices or accessories (such as masks, tubing, headgear) using ozone gas or ultraviolet (UV) light are not legally marketed for this use by the FDA in the United States, and as such, their safety and effectiveness for use with CPAP devices and accessories is unknown.
Read MoreMerck has received approval from the U.S. Food and Drug Administration (FDA) for an update to the...
Read MoreThe Food and Drug Administration (FDA) is advising consumers not to purchase or use U-Dream Full Night, a product promoted and sold as a sleep aid on various websites, as an FDA aboratory analysis confirmed that U-Dream...
Read MoreAn FDA-approved drug for restless legs syndrome is included. The US Food and Drug Administration...
Read MoreIn a 39-page letter dated October 21, 2019, the US Food and Drug Administration (FDA) responded to...
Read MoreThe FDA recently published a drug trials Snapshot on Wakix for narcolepsy, which highlights who participated in the clinical trials that supported the FDA approval of this drug, and whether there were differences among sex, race...
Read MoreAvadel Pharmaceuticals plc, a company focused on developing once-nightly sodium oxybate, FT218, for narcolepsy, reports that the U.S. Food and Drug Administration (FDA) has agreed to the company’s proposed amendments to...
Read MoreThe US Food and Drug Administration (FDA) issued a notice requesting nominations for voting...
Read MoreVanda Pharmaceuticals Inc received a complete response letter (CRL) from the US Food and Drug Administration (FDA) on Aug 16 as part of the FDA’s ongoing review of Vanda’s supplemental New Drug Application...
Read MoreVanda Pharmaceuticals Inc received a notification from the US Food and Drug Administration (FDA) on July 19 stating that as part of its ongoing review of Vanda’s supplemental New Drug Application (sNDA) for HETLIOZ...
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