The FDA has released a report outlining the possible benefits and risks of AR/VR medical devices and its overall thinking on the emerging class of products. The healthcare sector is undergoing a transformation due to the adoption of Augmented Reality and Virtual Reality (AR/VR) that offers cutting-edge diagnostic and treatment options and is revolutionizing care delivery. AR/VR technologies offer remote delivery of highly realistic and immersive content that allows for precision and safer preparation and performance of medical procedures by physicians, caregivers, and patients.
Augmented Reality (AR) and Virtual Reality (VR) are rapidly gaining traction in healthcare as they offer innovative diagnostic and treatment options that are transforming the way care is delivered. AR overlays digital images on top of the real world, enhancing and augmenting the user’s experience. It provides highly immersive and interactive content that can help physicians, patients, and caregivers prepare for and perform medical procedures with greater accuracy and safety. On the other hand, VR replaces the user’s physical surroundings with a completely simulated, immersive, and interactive environment that allows for the development of new, safe, and highly personalized treatment options.
The combination of AR and VR, known as extended reality, is frequently used to cover both approaches, but we will use them individually for the purposes of this article. These digital technologies have already shown great promise in treating patients with various medical conditions. For example, during surgical procedures, AR can overlay medical images onto a patient to help guide the surgeon’s technique, making the procedure safer and more accurate. VR has been used to treat post-traumatic stress disorder in army veterans, allowing them to confront their trauma in a controlled and safe environment. Additionally, VR rehabilitation therapy can simulate real-life situations to improve the physical functions of patients who have suffered physical disabilities resulting from a stroke or other medical conditions.
AR/VR technologies have the potential to make healthcare more accessible by delivering clinical services that were previously only available in clinical settings to patients in their homes or other non-clinical settings. This can be particularly beneficial for socioeconomically vulnerable and underserved communities, as well as the elderly or disabled, who may face difficulties in accessing in-person medical services. By enabling patients to complete treatment and monitoring regimens more easily, AR/VR could help to improve patient outcomes. These technologies are already being used to treat a wide range of medical conditions across different treatment domains, including pediatric diagnostics and treatments, pain management, mental health, neurological disorders, surgery planning, and ophthalmic diagnostics.
Despite their many benefits, AR/VR medical devices may also introduce new risks, such as neck pain from the weight of the headset or low contrast images, display errors such as location or depth of anatomy, information overload, dizziness, fatigue, or effects on vision. Furthermore, some of the risks associated with AR/VR medical devices may disproportionately affect vulnerable populations, such as children or patients with mental health or cognitive impairment. As such, it is important for manufacturers and healthcare providers to be aware of these risks and work to mitigate them to ensure that patients receive safe and effective treatment. Despite the potential risks, the benefits of AR/VR medical devices are vast, ranging from mitigating preoperative anxiety and making procedures less invasive to accelerating diagnoses and allowing for self-directed care.
The FDA has already approved an increasing number of devices for medical use through its 501(k) clearance scheme. These devices include AppliedVR’s ‘EaseVRx’, Novarad Corp.’s ‘VisAR’, and Penumbra’s ‘REAL Immersive System’.
As the medical industry continues to evolve and embrace digital transformation, the potential for AR/VR technologies to create novel treatment options that are more effective, safer, and highly personalized is enormous. The FDA appears to be committed to fostering innovation while also ensuring that patients receive safe and effective medical treatment. The FDA has welcomed any questions or concerns about the use of AR/VR medical devices, and has encouraged individuals to reach out to them for more information. As these technologies continue to advance, we can expect to see more sophisticated and tailored treatments that improve patient outcomes and transform the healthcare industry. The increasing number of AR/VR devices being used to treat a wide range of medical conditions, from pain management to surgery planning, highlights the exciting future of augmented reality in healthcare.