FDA Approves Inspire Medical’s New Physician Programmer Platform
A new telemetry cable enables Bluetooth connectivity to the programmer tablet. The platform interfaces with Inspire Cloud.
A new telemetry cable enables Bluetooth connectivity to the programmer tablet. The platform interfaces with Inspire Cloud.
EVO is the first oral appliance to use ProSomnus' MG6 technology, which combines high-performance medical-grade materials, manufacturing robotics, and AI.
The 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.
FDA approval of WAKIX for the treatment of cataplexy in adult patients with narcolepsy is based on two randomized, controlled trials.
Read More“There is significant need for greater awareness of idiopathic hypersomnia, which can severely impact a person’s daily life, and can often be misdiagnosed or undiagnosed over a substantial period of time.”
Read MoreBenzodiazepines are ‘commonly abused and misused, often together with opioid pain relievers and other medicines, alcohol, and illicit drugs.’
Read MoreHETLIOZ (tasimelteon) improved sleep quality and increased sleep duration in patients with Smith-Magenis Syndrome in a placebo-controlled clinical study.
Read MoreThe product is a CPAP mask that was modified by combining it with an N95.
Read MoreNoctrix Health aims to treat RLS symptoms with its wearable neuromodulation platform that targets specific peripheral nerve fibers in a manner that is comfortable to wear to sleep.
Read MoreSleep 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 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...
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