Transcend Auto Receives FDA Clearance for Sleep Apnea Therapy System

Somnetics International Inc. has received U.S. Food and Drug Administration clearance to market the Transcend Auto full-feature auto-adjusting positive airway pressure (APAP) unit with Transcend EZEX pressure relief technology on exhalation. The Transcend Auto offers people diagnosed with sleep apnea a small, light and portable therapy device and accessories that can be used at home or while traveling.

The new Transcend Auto automatically adjusts therapy pressure during sleep to help patients overcome episodes of sleep disordered breathing. It weighs less than one pound and is compatible with any continuous positive airway pressure mask. Transcend Auto can be used with the new Transcend heated humidifier and all Transcend accessories including the portable batteries and solar battery charger.

European regulators approved the Transcend Auto unit in March 2013.

“The Transcend Auto is a significant expansion for the Transcend product line and demonstrates our commitment to designing sleep apnea devices that meet the lifestyle needs of active patients,” Somnetics President/CEO Clarence Johnson said. “Our objective is to design sleep apnea devices that meet the lifestyle needs of active patients.”

More than 18 million U.S. residents are diagnosed annually with obstructive sleep apnea, with more than 40 million suffering from a chronic sleep disorder, according to the National Institutes of Health. Sleep apnea is a chronic condition that requires long-term management and for which continuous positive airway pressure or APAP devices are prescribed to provide constant, mild air pressure that keeps the airways open to provide a restful night of sleep.

Somnetics International Inc. is a privately-held medical device company based in Minneapolis, Minn., that designs, develops and produces medical devices to treat sleep apnea and related issues.