ENTRAINE®™ is a product and service based on the knowledge and experience accumulated for many years of research and development of BRAINWAVE ENTRAINMENT protocols for the end users.
ENTRAINE®™ incorporates multiple evidence-based & scientific technologies, processed and embedded in immersive AUDIO-VISUAL ENTRAINMENT matrices.
ENTRAINE®™ delivers a therapeutic “audio-visual massage” to your brain, via special PATENTED TECHNOLOGY, combining specific frequencies into various forms of synchronized auditory and visual stimulation.
ENTRAINE®™ will assist your daily wellbeing, performance, and resilience. Its effects and benefits typically increase with ongoing use as your brain adjusts to the stimulation.
ENTRAINE®™ is available anytime and anywhere on any device that has 4G/LTE or Wi-Fi network.
Software as a Medical Device (SaMD) is a medical software solution that can perform one or more medical functions without any need for a device itself. SaMD applications are intended to treat or prevent diseases and are typically used with non-medical hardware connected to virtual networks.
The International Medical Device Regulators Forum (IMDRF) agreed upon the key definitions for SaMD, framework for risk categorization for SaMD, the Quality Management System for SaMD, and the clinical evaluation of SaMD.
Criteria for distinguishing a SaMD application from any other ones:
*SaMD can be used in cooperation with hardware medical devices and integrated into the entire clinic ecosystem
Digital therapeutics (DTx) deliver medical interventions directly to patients using evidence-based, clinically evaluated software to treat, manage, and prevent a broad spectrum of diseases and disorders. DTx products are held to the same standards of evidence and regulatory oversight as traditional medical treatments.
DTx eliminate gaps in care by:
*DTx are regulated by FDA (USA) and DiGA (Germany and Europe)
BrainWave Entrainment(BWE), also referred to as brainwave synchronization and neural entrainment, refers to the capacity of the brain to naturally synchronize its brainwave frequencies with the rhythm of periodic external stimuli, most commonly auditory, visual, or tactile. Patterns of neural firing, measured in Hz, correspond with states of specific neural activity such as:
Audio-Visual Entrainment (AVE), a subset of brainwave entrainment, uses flashes of lights and pulses of tones to guide the brain into various states of brainwave activity. Altering brainwave activity can help in the treatment of psychological and physiological disorders.
Audio entrainment can be achieved with combining:
Visual entrainment can be achieved with combining: