Electromed, Inc. Announces U.S. Food and Drug Administration 510(K) Clearance of Fifth Generation Hfcwo Airway Clearance Generator
November 30, 2022 at 02:00 pm
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Electromed, Inc. announced that it received U.S Food and Drug Administration (“FDA”) 510(k) clearance of the SmartVest® Clearway® Airway Clearance System, which is designed for High Frequency Chest Wall Oscillation (“HFCWO”) therapy. The SmartVest Clearway system, an updated and modern approach to HFCWO, offers an enhanced patient experience with proven patient outcomes. The SmartVest Clearway system uses HFCWO, a clinically proven therapy that helps clear the lungs of excess secretions, thereby reducing the risk of respiratory infections and hospitalizations for those suffering from a chronic lung condition.1 HFCWO delivers alternating pulses of air into a vest garment that rapidly compresses and releases the chest wall, resulting in an oscillation in airflow within the airways that acts to loosen, thin, and propel mucus toward the major airways where it can be expectorated.
The SmartVest Clearway Airway Clearance System is designed to deliver high frequency chest wall oscillation to promote airway clearance and improve bronchial drainage. The SmartVest System is indicated when external chest manipulation is the physician's treatment of choice to enhance mucus transport. HFCWO therapy is often prescribed for illnesses such as non-cystic fibrosis bronchiectasis (NCFB) and other chronic pulmonary conditions.
Electromed, Inc. develops, manufactures, markets and sells products that provide airway clearance therapy, including the SmartVest Airway Clearance System, to patients with compromised pulmonary function. The Company applies High Frequency Chest Wall Oscillation (HFCWO) technologies in pulmonary care for patients of all ages. The SmartVest Clearway System consists of an inflatable therapy garment, a programmable air pulse generator and a patented single-hose that delivers air pulses from the generator to the garment to create oscillatory pressure on the chest wall. Its SmartVest Connect wireless technology is a personalized HFCWO therapy management portal for patients with compromised pulmonary function. The SmartVest Connect app securely connects to the SmartVest System through Bluetooth technology. The Company also markets the Single Patient Use (SPU) SmartVest and SmartVest Wrap to health care providers in the acute care setting.
ELECTROMED, INC. 
