The Magazine for Sleep Professionals
Saturday, October 10, 2026
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 […]
The American Thoracic Society applauds Michigan Governor Gretchen Whitmer’s decision to ban the sale of all flavored e-cigarette and vaping products in the state of Michigan. Governor Whitmer’s decision is an appropriate response to the 215 recently reported cases of e-cigarette triggered acute illnesses that have resulted in hospitalization and in at […]
The Food and Drug Administration (FDA) is advising that rare but serious injuries have happened with certain common prescription insomnia medicines because of sleep behaviors, including sleepwalking, sleep driving, and engaging in other activities while not fully awake. These complex sleep behaviors have also resulted in deaths. These behaviors appear […]
Dräger today announced it has received FDA 510(k) clearance for its Savina 300 SW 5.0, the latest in its line of Savina ventilators. The Savina 300 SW 5.0 offers advanced features such as automatic tube compensation (ATC) to aid clinicians in their daily workflow, and improve patient comfort by reducing artificial […]
On September 5, 2017, Smiths Medical ASD issued a voluntary recall of 71 lots of Sterile Water and Saline for Inhalation USP Products (described in further detail below) that either lacked sufficient documentation to assure sterility or may have been susceptible to leaking. Sterile Water for Inhalation USP (350 mLand 550 mL Humidifier with […]
A new version of Primatene Mist will soon return to the shelves of U.S. stores. The FDA approved the over-the-counter aerosol inhaler late Wednesday. It’s indicated for temporary relief of mild, intermittent asthma symptoms in people ages 12 and up. The original Primatene Mist disappeared seven years ago when the […]
Zephyr Sleep Technologies Inc. (Zephyr), an innovation leader in bringing new products and technology to the field of dental sleep medicine, is announcing the U.S. Food and Drug Administration (FDA) has granted a De Novo request for the MATRx plus™ a new class of medical device – the first ever […]
Vertex Pharmaceuticals Incorporated announced the U.S. Food and Drug Administration (FDA) has approved ORKAMBI® (lumacaftor/ivacaftor) to include use in children ages 2 through 5 years with cystic fibrosis (CF) who have two copies of the F508del-CFTR mutation, making it the first medicine approved to treat the underlying cause of CF […]
