The Magazine for Sleep Professionals
Sunday, September 20, 2026
Sommetrics, a private company developing products and services to improve sleep health, has announced its lead sleep apnea product, aerSleep II, has received FDA Breakthrough Device designation. This program allows for additional FDA feedback to sponsors during the pre-marketing phase but does not alter the basic requirements for market authorization. […]
The US Food and Drug Administration (FDA) has permitted marketing of a new device intended for the temporary reduction of sleep disturbance related to nightmares in adults 22 years or older who have nightmare disorder or who have nightmares from post-traumatic stress disorder (PTSD). The device provides gentle vibration through […]
Harmony Biosciences Holdings, Inc. announced the FDA has approved WAKIX® (pitolisant) for the treatment of cataplexy in adult patients with narcolepsy. WAKIX is the first and only treatment approved by the FDA for people with excessive daytime sleepiness or cataplexy associated with narcolepsy that is not scheduled as a controlled […]
The CDC released data from the recent National Youth Tobacco Survey showing that in 2020, 20 percent of high school students and nearly 5 percent of middle school students used e-cigarettes. Most concerning, the data shows that among youth e-cigarette users, 38.9 percent of high school students and 20 percent […]
GlaxoSmithKline plc and Innoviva, Inc. announced the US Food and Drug Administration (FDA) has approved a new indication for Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol ‘FF/UMEC/VI’) for the treatment of asthma in patients aged 18 years and older adding to its current license for use in patients with chronic obstructive pulmonary disease […]
Fitbit has developed a high-quality, low-cost, easy-to-use emergency ventilator, Fitbit Flow, which has obtained Emergency Use Authorization (EUA) from the U.S. Food & Drug Administration (FDA) for use during the COVID-19 public health emergency. After seeing the global need for ventilators, Fitbit applied its deep in-house expertise in advanced sensor development […]
Inspire Medical Systems, Inc. announced today that the U.S. Food and Drug Administration (“FDA”) has approved an expanded age range for Inspire therapy to include 18-21-year-old patients, as compared to the previous minimum age requirement for patients to be 22 years old. Following a detailed review of the clinical evidence […]
On April 14, 2020, the U.S. Food and Drug Administration granted 3B Medical Emergency Use Authorization for 3B Medical’s new High-Flow H80 System and its Luna BPAP ST non-invasive respiratory devices. These devices may now be used in the U.S. during the COVID-19 public health emergency. “Both of these devices […]
Vapotherm, Inc. has announced that the FDA recently granted Breakthrough Device Designation for the Company’s Oxygen Assist Module (OAM). FDA’s Breakthrough Device Program is intended to help patients and healthcare providers receive more timely access to breakthrough technologies that have the potential to provide more effective treatment or diagnosis of […]
Masimo announced that continuous RRp® (respiration rate from the photoplethysmograph) monitoring of adult and pediatric patients with Rad-97®, Radical-7®, and Radius-7® Pulse CO-Oximeters® has received FDA clearance. With this clearance, both continuous and spot-check RRp are now available in the US, supported in a variety of pulse oximetry sensors and configurations, including the […]
