The Magazine for Sleep Professionals
Friday, June 19, 2026
AcuPebble SA100, a small wearable device that enables automated, remote home testing to detect obstructive sleep apnea (OSA) in adults, has obtained FDA 510(k) clearance as a Class II medical device in the USA. The device, developed and commercialized by UK-based medical device company Acurable, builds on more than ten […]
ALung Technologies, Inc., the leading provider of low-flow extracorporeal carbon dioxide removal (ECCO2R) technologies for treating patients with acute respiratory failure, announced that the Food and Drug Administration (FDA) has granted the Company De Novo clearance for the Hemolung Respiratory Assist System. The Hemolung System is the first and only […]
GE Healthcare announced it has received Food and Drug Administration (FDA) 510(k) clearance for an artificial intelligence (AI) algorithm to help clinicians assess Endotracheal Tube (ETT) placements. The AI solution is one of five included in GE Healthcare’s Critical Care Suite 2.0, an industry-first collection of AI algorithms embedded on […]
Due to potential health risks, Philips Respironics voluntarily recalled certain continuous positive airway pressure (CPAP) machines over the summer. , the polyester-based polyurethane (PE-PUR) sound abatement foam runs the risk of breaking down and potentially entering the device’s air pathway. Under these circumstances, it is said that black debris from […]
Inspire Medical Systems, Inc. is providing an update on the 2022 Reimbursement payment rates for Inspire procedures performed in Ambulatory Surgical Centers (ASCs). The Centers for Medicare and Medicaid Services (CMS) today published updated addendum files for the 2022 ASC payment system, including updating the assigned device offset percentage and […]
The American Lung Association in Kansas and Greater Kansas City will host a lunch and learn webinar, sponsored by Vitalograph, on Wednesday, November 17 at 12:00 p.m. CT. The free virtual event, which takes place one day before the Great American Smokeout (an annual nationwide campaign to quit smoking), will […]
As America prepares to observe Veterans Day in honor of those who served, fought, and died for us, AirAvant Medical and First Nation Group announce a partnership alliance providing the FDA-cleared Bongo® Rx Expiratory Positive Airway Pressure (EPAP) device to Veterans and active-duty military members suffering from Obstructive Sleep Apnea (OSA). The partnership between First Nation […]
Turn Medical has launched its first product, a prone positioning device, the Pronova-O2™ Automated Prone Therapy System. Substantial research has demonstrated the benefits of prone positioning for critically ill patients with respiratory distress. The Pronova-O2™ System provides an effective and efficient way for clinicians to move patients into the prone position and maintain […]
Masimo has announced Dual SET® Pulse Oximetry for Root®, a highly versatile patient monitoring and connectivity hub. The first application of Dual SET® Oximetry is a significant advancement to Masimo SET®-guided critical congenital heart disease (CCHD) screening, with the CE marking and European launch of the Masimo SET® MOC-9® module and the addition of […]
By Sean B. Gipson, RPSGT There are many sleep techs who ask me how I got started in running a sleep business and sleep diagnostic centers. Sparing readers a long story, in my pre-ownership days, I often thought at night while I was running studies that it couldn’t be too […]
