The U.S. Food and Drug Administration (FDA) granted this important designation to Lungpacer’s technology in recognition of its potential to provide more effective treatment than the standard of care available today for patients who have difficulty getting off of mechanical ventilation. The goal of the Breakthrough Devices Program is to provide patients and health care providers with timely access to medical devices like the AeroPace system by prioritizing their development, assessment, and regulatory review consistent with the Agency’s mission to protect and promote public health.  More information at https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program.