The Magazine for Sleep Professionals
Friday, August 28, 2026
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 […]
Novel Low-Flow Technology Has Demonstrated Efficacy in Obstructive Sleep Apnea Patients FRESCA Medical, Inc., a privately held sleep solutions and connected health company, announced that the FDA granted their de novo request to market the CURVE™ Positive Airway Pressure delivery system for the treatment of obstructive sleep apnea (OSA). The […]
New initiative to describe unmet medical needs & treatment expectations from patient point-of-view On June 8, 2018, for the first time ever, sleep apnea patients and their family members will share perspectives on what it’s like to live with sleep apnea with FDA regulators, drug and medical device developers, and […]
It is with great interest, and some skepticism, that the ATS views the FDA’s recent proposal to reduce nicotine levels in cigarettes to non-addictive levels. In a perfect world, creating a non-addictive cigarette product might be the “silver bullet” we are looking for to reduce the death and disease caused by tobacco […]
