International Biophysics Corporation, a medical device manufacturer, recently announced that the company received the CE Mark and approval from Health Canada and the Australian Therapeutic Goods Administration (TGA) for its AffloVest. This means that the company will now be able to market and sell the vest in Canada, Australia, New Zealand, countries of the European Union, and others using the CE mark.
“Gaining these approvals is an exciting achievement for us. We are very happy to now be able to provide this innovative technology to patients in our neighboring Canada, as well as Australia, New Zealand and the rest of the world. We have also completed expanding our internal salesforce to now allow us nationwide sales and product support coverage here in the USA,” said H. David Shockley Jr., the CEO of International Biophysics, in a press release.
AffloVest is a high frequency chest wall oscillation (HFCWO) vest. It promotes airway clearance and improves bronchial drainage by enhancing the mobilization of bronchial secretions. It can be prescribed in the U.S. to people with certain lung diseases, including bronchiectasis and cystic fibrosis, as well as for other conditions affecting breathing, such as multiple sclerosis, quadriplegia, muscular dystrophy, myotonic disorders, myopathies, and disorders of the diaphragm.
AffloVest has been shown to increase lung function in clinical studies. Measures such as Forced Vital Capacity (FVC), which is the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible, Forced Expiratory Volume in one second (FEV1), and Forced Expiratory Flow (FEF), which is the flow (or speed) of air coming out of the lung during forced expiration, were all improved with the use of AffloVest.
The company recently moved production of the vest back to the U.S., and it is now made in Austin, Texas. “This innovative product is now ‘Made in the USA.’ This internal on-shore manufacturing will add permanent manufacturing and engineering jobs here, and increase our ability to remain competitive globally while meeting the growing customer demand for the AffloVest both here and internationally,” Shockley said.
According to the company, the latest design offers several new features compared to previous models. These include a better overall tailored fit, a “more fashionable” denim color, an electronic digital programmable controller with compliance monitoring, a longer battery life, and more sizes.