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XR in Medical Devices: Innovation, Regulation, and Transformation in Healthcare


atención médica

Extended Reality (XR) technology, encompassing Augmented Reality (AR) and Virtual Reality (VR), has moved from being a futuristic promise to becoming a tangible tool in the healthcare sector.


From rehabilitating patients with motor and cognitive impairments to training medical professionals in simulated environments, XR is revolutionizing how we understand and practice medicine.


This article explores the role of XR in healthcare, the scientific evidence behind its benefits, and the regulatory process that ensures the safety and efficacy of these innovative medical devices.


Extended Reality in Healthcare: A New Era of Immersive Therapies

XR, which includes AR and VR technologies, enables the creation of immersive and controlled environments that have demonstrated significant therapeutic applications.


These technologies rehabilitate motor functions, enhance cognitive abilities, and, in many cases, help manage symptoms associated with various pathologies, from pain to fatigue.


In the specific case of rehabilitation, VR allows the creation of simulations in which patients can explore and practice repetitive motor and cognitive tasks in a safe and controlled environment.


This is particularly useful in neurorehabilitation, where patients need to retrain movements and skills lost due to traumatic brain injuries, strokes, or neurodegenerative diseases.


In this context, VR can provide an enriched experience that promotes neuroplasticity, encouraging motor relearning through progressive and adaptive tasks designed to improve fine and gross motor functions.


Scientific Evidence of Virtual Reality's Therapeutic Impact

evidencia científica



A growing body of scientific evidence supports VR's positive impact on rehabilitation. Neurophysiological studies have shown that immersive VR environments activate key brain areas related to motor learning and attention, which are essential in neurological rehabilitation.


This brain activation enhances performance in motor and cognitive tasks, as well as patients' motivation to adhere to treatment​​.


An important aspect of VR treatments is the perception-action interaction, where patients not only receive visual and auditory stimuli but also execute movements, complete tasks, and receive real-time feedback.


This feedback is fundamental for motor learning, as it allows patients to adjust their movements based on the outcomes achieved.


According to recent research, this repetitive and adaptive practice not only improves motor skills but also stimulates neuroplasticity, helping the brain reorganize and recover lost motor functions​.


Furthermore, studies have shown that VR promotes greater treatment adherence and reduces symptoms such as pain and fatigue by using distraction mechanisms to manage pain and anxiety, enhancing the sense of "presence" in a safe environment.

This makes sessions not only more tolerable but also more effective and enjoyable for patients.


Use Cases of VR in Rehabilitation: Practical Examples and Benefits

VR in rehabilitation enables patients to perform motor and cognitive exercises in customized three-dimensional environments, such as simulating daily tasks that require precision and motor coordination, under the supervision of therapists.


For example, Kinesix XR devices offer simulations of daily life activities, designed by neurorehabilitation specialists, allowing patients to practice tasks like grasping objects, manipulating tools, or even simulating complex scenarios, such as preparing a recipe or performing activities in a gym.


Kinesix XR not only offers simulations but also enriched environments of non-task-oriented interaction based on playful movement exploration, aimed at generalizing motor and cognitive gains.


These simulations and playful exercises not only improve physical functionality but also increase patient motivation by immersing them in a game-like environment, providing a positive experience with constant feedback​.


Another relevant use case is telerehabilitation, allowing patients to perform rehabilitation exercises from their homes, which is particularly useful for people with limited mobility or those living in remote areas.


The FDA has started to consider telerehabilitation as a viable extension of in-person treatments, as long as safety conditions are maintained and devices can provide adequate supervision of progress.


The Importance of Safety in Medical VR Devices

Safety is one of the top priorities in the evaluation of VR devices for healthcare. When hardware is used with patients who have balance issues, it must feature design characteristics that minimize the risk of falls or injuries.


Kinesix XR, for instance, has implemented follow-up systems that allow real-time adjustments of exercise conditions to reduce these risks​.


Another important safety consideration is the device's ability to adapt to each patient’s individual needs. This entails customizing activities and exercises to match specific levels of mobility and skill for each user, as well as including remote supervision by therapists when needed.


Kinesix XR also incorporates mixed reality, which combines virtual and real elements, reducing the risk of falls, bumps, and dizziness by allowing the real environment to be visualized alongside virtual elements.


With its practical applications in rehabilitation, symptom reduction, and improved patient quality of life, extended reality represents one of the most innovative areas in medicine.


As the FDA, CE, HealthCanada, and other regulatory bodies continue adapting their policies to meet these new technological challenges, the XR field will continue to evolve, integrating increasingly complex and safe applications in the clinical field.




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