The term medical technology refers to the application of scientific knowledge and skills in the form of devices, medicine, vaccines, procedures, and systems made to solve a health problem and improve patients’ quality of life (Ten Haken et al., 2018).  The technological developments observed in the 21st century have led to tremendous changes in healthcare (Thimbleby, 2013). What could be thought of as science fiction a couple of decades prior is, now, everyday medical practice. From the use of robots (Hockstein et al., 2007) to tailoring therapy to each patient’s needs (Mathur and Sutton, 2017), modern medicine could be considered an advanced technological profession (Mesko, 2018). This notion is further reinforced by the introduction of modern engineering, information technology and wireless communications in everyday medical practices. 

Established under the Translational Research Clause of the 21st Century Cures Act, CalenDarer Digital Therapeutics utilizes the protective regulatory parameters of its proprietary computer software source code INSIDE and OUTSIDE of the Medical Device Hardware to establish Cybernetics for designing, developing and deploying Digital Therapeutic medical device innovations that correct rare medical conditions.