Sleep apnea treatment device startup Sommetrics announced yesterday that its quality management system has been certified to the 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,” said Kent Gandola, VP of engineering and quality systems, in a news release. “It reflects the continuing effort of our employees to build a solid foundation for making the transition from an R&D company to one poised for commercial success.”
Landing these certifications allows Vista, Calif.-based Sommetrics to apply to HealthCanada for market clearance of its aerSleep device targeted for the treatment of obstructive sleep apnea (OSA). The device has not been cleared in the U.S.
“These certifications create a number of opportunities for Sommetrics,” said Dr. Richard Rose, president & CEO. “It’s a major step toward 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 obstructive sleep apnea severity, according to the company. In these studies, the majority of people tested found aerSleep to be preferable to CPAP the most commonly prescribed OSA therapy.
“An important advantage of aerSleep in the COVID-19 era is that it is completely non-invasive,” Rose said. “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.“