In 2015 the US congress passed legislation to formally create Breakthrough Device Designation. The program was created to help expedite breakthrough technologies that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The ultimate goal of this program is to provide patients and healthcare providers with timely access to these medical devices by speeding up their development, assessment and review. Once admitted, the program provides the sponsor with expedited review and a more interactive experience with the agency. Breakthrough Device is NOT a market notification and does not give the sponsor the ability or right to distribute their device in the US.