BreatheSuite announced that the FDA has cleared the company’s disposable BreatheSuite MDI device, which attaches to the top of a standard metered dose inhaler canister to provide inhaler usage monitoring and feedback to the patient and to health care providers through an associated mobile app. According to BreatheSuite, the device has also been cleared by Canadian authorities.
BreatheSuite CEO Brett Vokey commented, “We are extremely excited to have obtained FDA clearance, which is a critical step in achieving our vision of improving the lives of respiratory patients worldwide. The COVID-19 pandemic has underscored that now is the time for remote patient monitoring to take a front seat in providing better, more transparent care for all people with asthma or COPD. With FDA clearance, we are poised to become a leader in providing actionable insights to people with asthma or COPD across the United States.”
Chief Scientific Officer Meshari F. Alwashmi added, “By having a real-time way to digitally monitor and provide feedback to patients, we hope to enhance healthcare outcomes. Furthermore, having an objective measure of adherence and technique from each user with asthma and COPD will advance the sphere of knowledge regarding the effectiveness of inhaled medications.”
Earlier this year, the Canadian company said that it had raised $1.2 million for distribution of the monitoring system and for further product development.
Read the BreatheSuite press release.
