DIGITAL THERAPEUTIC
The Regulaltroy Framework of the CalenDarer Computer Software system was translated into Image Artificial Intelligence, enabling the design, development and deployment of Prescriptions for Digital Therapeutic Medical Device Innovations.
A digital therapeutic (DTx) is a software-based intervention that treats, prevents, or manages a medical condition. DTxs are designed to be tailored to the needs of each patient. DTxs use digital tools like apps, sensors, and virtual reality to collect data about a patient's behavior, physiology, and social and geographical patterns. In the majority of all cases, if not all, DTx are limited to the utilization of software programs within the hardware technology, but with the nuance of Artificial Intelligence as a Medical Device and Virtual Computer Systems, the computer software is also utilized outside of the hardware technology to reach and correct rare medical conditions that typical DTx cannot treat.
Via the translation of Natural Language Code to Computer Language Code to Image Artificial Intelligence, Prescriptions for Cybernetic Digital Therapeutics are applied via psychological means to engage the autonomic nervous system in order to deliver the 21st Century Cure to the patient via the central nervous system.
PHARMACEUTICAL
The physiologic effect of gabapentin is by means of Decreased Central Nervous System Disorganized Electrical Activity.
- 21 U.S. Code Chapter 9 -
MEDICAL DEVICE
The physiologic effect of CalenDarer DTx is by means of Removal of Central Nervous System Disorganized Electrical Activity.
- 28 USC § 3002 (15)(a)(b)(c) -
The Regulatory Blockchain, a Distributed Cybernetic Ledger framework of virtual computer environments founded on the utilization of law (28 USC § 3002(15)(a)(b)(c) to operate under healthcare law (The 21st Century Cures Act), for the translation, design, development and deployment of Prescriptions for Cybernetic Digital Therapeutic Medical Device innovations.
The Regulatory Blockchain utilizes cybernetic periodic table infrastructure and isolates an Enigma Algorithm ledger against a proprietary Turing Algorithm to translate, design, develop and deploy Digital Therapeutic Medical Device Innovations that treat pain stemming from neurological disorder or injury through its own Programming Language.
Clinical trials are carefully designed research studies that evaluate safety, efficacy and effectiveness of new treatments or interventions via the utilization of the translational Research Clause of The 21st Century Cures Act. The process involves screening for eligibility, providing informed consent, actively participating in the study sometimes for prolonged periods and undergoing monitoring by experienced healthcare professionals.
Via the utilization of Cybernetic Technology, Artificial Intelligence, Blockchain Technology and Software Technology, purposeful modulation of the nervous system's activity can be achieved without invasive (e.g. microelectrodes) or non-invasive means (e.g. transcranial magnetic stimulation or transcranial electric stimulation, tES, such as tDCS or transcranial alternating current stimulation, tACS) to offer a solution for difficult to treat medical conditions such as pain stemming from Complex Regional Pain Syndrome and Post Concussion Syndrome.
With multiple Digital Medicines in the pipeline for mental health conditions and Congress reviewing "The Access to Prescription Digital Therapeutics Act", the move is swift to quickly identify, design and build Prescriptions for the Cybernetic Digital Therapeutic that offer consistent patient solutions.
*Please download and review the Costs Analysis for CRPS, a medical condition that is cured by one of Caluber's novel Cybernetic Medical Device Innovations.
TECHNICAL BACKGROUND
CalenDarer - The Social Calendar Network is a computer software system that was utilized to translate Natural Language Programming Code of Human Body Activity to Software Language and then to Image Artificial Intelligence for the design, development and deployment of Prescriptions for Cybernetic Medical Device Innovations that treat and/or cure rare medical conditions stemming from neurological disorder or injury, including nerve pain.
The clinical trial proved the ability of the software code to behave as a Medical Device, curing numerous rare medical conditions, resulting in a valuation for the medical innovation in the amount of $630 Million. The Medical Device Innovations are administered via psychological means and requires a licensed clinical psychologist be trained in the treatment planning process or implementation of the Artificial Intelligence algorithms in order to administer Artificial Intelligence as a Medical Device (AIAAMD) to provide medical solutions within psychiatry.
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