Electromed (NYSE:ELMD) announced today that it received FDA 510(k) clearance for its SmartVest Clearway airway clearance system.
New Prague, Minnesota-based Electromed designed the system for high-frequency chest wall oscillation (HFCWO) therapy. It represents the fifth generation of Electromed’s technology.
According to a news release, the updated approach to HFCWO offers an enhanced patient experience with proven patient outcomes.
“It is our goal to make home airway clearance easier and more convenient for patients, while continuing to provide a superior product, proven outcomes, and outstanding patient service,” said Kathleen Skarvan, president and CEO of Electromed. “SmartVest Clearway meets these goals with its intuitive touch screen, the lightest weight generator on the market, and smaller footprint than our previous generation, which continues our history of innovation in HFCWO therapy.
“We are proud to further our mission and assist more patients to breathe easier and improve their quality of life.”
SmartVest Clearway’s HFCWO therapy helps clear the lungs of excess secretions. This reduces the risk of respiratory infections and hospitalizations for those with chronic lung conditions.
HFCWO delivers alternating pulses of air into the vest garment that rapidly compresses and releases the chest wall. That results in an oscillation in airflow within the airways. This oscillation acts to loosen, thin and propel mucus toward the major airways for expectoration.
The therapy is often prescribed for illnesses such as non-cystic fibrosis bronchiectasis (NCFB) and other chronic pulmonary conditions.
Electromed intends to begin a limited market release in the U.S. in the coming weeks.