Sommetrics, Inc., which provides products to treat airway obstruction during sleep and in acute care settings, announced today that its quality management system has been certified to the rigorous ISO 13485:2016 standard. During the audit process required for certification, Sommetrics was also evaluated and found to be in compliance with the standards of the Medical Device Single Audit Program (MDSAP) for Canada. “This is an important milestone for Sommetrics,” commented Kent Gandola, Vice President of Engineering and Quality Systems. “It reflects the continuing effort of our employees to build a solid foundation for making the transition from a R&D company to one poised for commercial success.”
As a result of the ISO and MDSAP certifications, Sommetrics is now able to apply to HealthCanada for market clearance of the aerSleep® device targeted for the treatment of obstructive sleep apnea (OSA). “These certifications create a number of opportunities for Sommetrics,” said Dr. Richard Rose, President and CEO. “It’s a major step towards taking aerSleep® into global markets where there is a growing need for better-accepted alternative ways of treating OSA, now considered the commonest chronic respiratory disease affecting up to 1 billion people worldwide.”
aerSleep® applies negative pressure to the outside of the upper airway via a soft silicone collar placed over the front of the neck. Since the battery-powered silent vacuum pump is an integral component of the device, no connection to an external vacuum or power source is needed. aerSleep® has been found to be safe and effective in clinical studies with all degrees of OSA severity. In these studies, the majority of people tested found aerSleep® to be preferable to CPAP the most commonly prescribed OSA therapy. Dr. Rose added, “An important advantage of aerSleep® in the COVID-19 era is that it is completely non-invasive. As a result, its use has no risk of generating infectious aerosols which can contaminate the environment – a hazard which has been associated with CPAP use and that can have devastating effects in nursing homes and other care settings.“
