QUEBEC, Montreal – September 22th 2017, THORASYS Thoracic Medical Systems Inc. is pleased to announce today that the U.S. Food and Drug Administration (FDA) has approved the sale and the distribution of the tremoflo C-100 Airwave Oscillometry System (AOS), a medical device that offers fast, easy assessment of large and small airway function. Measurements are obtained during tidal breathing and without patient effort, which makes it a suitable device for a wide range of patients.
“Today’s approval is the payoff of more than seven years of persistent hard work by the THORASYS team to develop the innovative tremoflo C-100.” said THORASYS co-founder, president & co-CEO, Thomas F. Schuessler. “The FDA approval represents a strategic milestone for THORASYS.” said THORASYS president and co-CEO, Yvan Beaudoin. The company will now import and distribute the FDA approved tremoflo C-100, classified as a medical device in the U.S.
About the U.S. Food and Drug Administration (FDA)
“The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.”1
About THORASYS Thoracic Medical Systems Inc.
THORASYS Thoracic Medical Systems Inc. is a respiratory medical device company based in Montreal, Quebec, Canada. THORASYS applies cutting edge research and technology to the development of products for pulmonary assessment. It designs, manufactures and commercializes pulmonary function test equipment for the assessment and monitoring of lung diseases such as Asthma and COPD. The company is currently focused on expanding.
You can find out more from our website at www.thorasys.com
1 U.S Food and Drug Administration https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements