Crestwood, KY, 24th January 2019 – Liberate Medical, a clinical stage medical device company, focused on the development of novel non-invasive neuromuscular electrical stimulation devices to address pulmonary conditions, announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the company’s VentFree muscle stimulator. The proposed indication for the device is preventing breathing muscle atrophy and reducing the number of days of ventilator support in adults who require mechanical ventilation.
The Breakthrough Device program is intended to expedite the process of bringing to market devices, for which no approved or cleared alternative exists, or that offer significant advantages over existing alternatives, and that treat life-threatening, or irreversibly debilitating, diseases or conditions. The benefits of the program…