Electromed gets FDA clearance to market next generation SmartVest Airway Clearance System

Electromed, Inc. (NYSE MKT: ELMD), a global medical device company, today announced it has received notification from the U.S. Food and Drug Administration that its next generation SmartVest^® Airway Clearance System, the model SQL™ has been cleared to market.

"SQL solidifies Electromed's innovation leadership by offering a device that is smaller, quieter, and lighter than our previous versions," said Kathleen Skarvan, Chief Executive Officer. "We designed the SQL to stand apart from the competition with features that our patients and clinicians were asking for. They talked, and we listened." In addition to being significantly smaller, quieter, and lighter than our previous versions, some of the features include enhanced ramping, an enhanced pause feature and more user-friendly graphics.

The model SQL is an electrically powered precursor device designed to deliver high frequency chest wall oscillation (HFCWO) to promote airway clearance, improve bronchial drainage and enhance mucus transport under the order of a physician's prescription. It is prescribed to patients with a wide range of pulmonary-related health conditions including bronchiectasis, chronic obstructive pulmonary disease (COPD), cystic fibrosis, muscular dystrophy, and cerebral palsy. HFCWO has been demonstrated to reduce lung infections and reduce health care costs associated with recurrent pneumonias, antibiotic use, and hospital stays. In addition to the innovative SQL generator, the system boasts a lightweight soft-fabric garment with several patented features.

"We believe we have the most comfortable and easy-to-use system among leading HFCWO devices, which leads to therapy adherence and better patient outcomes," Skarvan added.

Electromed anticipates that the model SQL will be available to the U.S. market within the next 60 days.