Regulatory Information

Registered Medical Applications by XRHealth IL Ltd.

FDA-registered VR apps

XRHealth catalogue of Medical VR applications includes over 140 VR environments, across 16 therapeutic areas, including chronic pain, musculoskeletal, motor-mapping, fine-motor, phobias, anxiety, trauma, mindfulness, and relaxation.

Balloon Blast PlayBalloon BlastWatch demo
2 Color match Game PlayColor MatchWatch demo
Mindfulness PlayMindfulnessWatch demo
Inside an AirplaneAirplaneWatch demo
5 Memorize PlayMemorizeWatch demo
6 Relaxation PlayRelaxationWatch demo
See all environments

Data Portal

The Data Portal provides real-time, aggregated data of every measurement and training performed in the VR applications.

The portal’s interface enables therapists to view patients progress over time, create and adjust patients training plans and more.

The Data Portal provides an end-to-end solution for telehealth and remote patient monitoring.

External Control

With our state-of-the-art External Control, XRHealth therapists can control and monitor patients’ live VR sessions, as well as make any necessary adjustments in real-time.

External Control can be accessed from a PC or Android tablet. Available for download from the Microsoft store or Mac App Store.

Compliance

XRHealth IL Ltd. has established a quality management system that indicates a commitment to quality and gives an assurance that its services and products are safe, accurate and effective, meet customer requirements, and comply with all applicable standards and regulations. XRHealth IL Ltd. is accredited for the EN ISO-13485:2016 AND ISO-27001:2013 standards by SII, the Standard Institution of Israel. It also complies with the requirements of the US FDA 21 CFR Part 820, to those of the Australian Therapeutic Goods Administration (TGA) and is further audited on a regular basis by customers and interested parties.

XRHealth IL Ltd. compliance obligations in terms of information security include, in addition to the ISO 27001:2013 accreditation, the Health Insurance Portability and Accountability Act (HIPAA) which addresses various security and privacy aspects in managing Protected Health Information (PHI) of US residents, the EU General Data Protection Regulation (GDPR) which addresses various security aspects in managing protected Personally Identified Information (PII) and the Privacy Low of Israel.

Release Notes

  • VR Portal
  • External Control
  • Data Portal
  • Mobile Application
  • Developers API
  • Approved Device List
  • Aug 04 2021

    1. Support of text messaging between the EC and Headset (for situations where you don’t want to interrupt verbally)
    2. Playlists in Mindset (you can set a custom playlist in the EC)

    XRHealth Portal 4.0.17

    Jun 21 2021

    1. Localization of the portal and onboarding experience (mainly for the IL clinic).
    2. Adding pairing a new external device from within the main screen enabling patients to ONLY LOGIN ONCE (and not have to logout on their first VR meeting in order to pair)
    3. Enabling to scroll between weeks on a training plan.

    XRHealth Portal 3.9.4
    February 10 2021
    Balloon Blast localization

    XRHealth Portal 3.8.12.12
    February 8th 2021
    Hot fix #2 for internet connectivity issues

    XRHealth Portal 3.8.12.6
    January 19th 2021
    Hot fix for performance issues with EC

    XRHealth Portal 3.8.12
    December 10th 2020
    Localization for Color Match and A10tion supporting Hebrew!

    XRHealth Portal 3.8.8
    November 22th 2020
    A10tion a new app for ADHD is now available in the USA!

    XRHealth Portal 3.7.2
    October 10th 2020
    Mindset – A new app for stress, pain and symptom management is available!
    Also a bunch of bug fixes and performance improvements to improve the user experience.

    XRHealth Portal version 3.6.9
    24 Sep 2020
    Bug fixes

  • External Control version 1.3.12

    May 16 2022

    External control bug fixes:

    – Fixed Rotate 2.0 Evaluation sessions
    – Fixed Rotate 2.0 motion difficulty not sent and loaded correctly

    External Control version 1.3.3

    Aug 04 2021

    The External Control app now enables:
    – Text messaging between the EC and Headset (for situations where you don’t want to interrupt verbally)
    – Playlists in Mindset (you can set a custom playlist for patients)

    External Control version 1.2.15
    21 February 2021
    Localization support

    External Control version 1.2.14
    February 8th 2021
    Hot fix #2 for internet stability issues

    External Control version 1.2.10
    January 19th 2021
    Hot fix for EC stability issues

    External Control version 1.2.5
    December 10th 2020

    1. Version update popup
    2. New disconnect/timeout handling
    3. Take control while patients are logged in (no need to logout any more!)
    4. Bug fixes

    External Control version 1.2.2
    November 22th 2020
    External control now supports A10tion! A new app for ADHD in the USA.

    External Control version 1.2.0
    October 10th 2020
    Support for Mindset, a new VR application!
    Performance and stability improvements 

  • Data portal version 1.11.0
    October 11, 2020

    • Clinichat – A secured and HIPAA-compliant communication channel between patients (Through the mobile app) to their associated clinician (Through the Web Portal)
    • Mindset – support for new Mindset application on Activities and Dashboards
    • Visualize VAS for Rotate on Web portal
    • Added a filter for evaluation on Overview main dashboard
    • Fix search functionality for “Technical support user”
    • Fixed a bug where clinicians could not use “External control” for patients that their password has expired

    Data portal version 1.11.1
    Nov 17, 2020

    • Clinichat Phase 2 (SMS notifications for our clinicians)
    • Added Primary and Secondary treatment case to patient forms in the web portal
    • Support for the upcoming VR Release of A10Tion / New MC320 version (more information with the upcoming release)

    Data portal version 1.11.2
    December 9, 2020

    • Display discharged and locked patients in the patient list.
    • Add a Patient information banner.
    • Create and view two user types for clinicians – “regular” and “clinician admin”.
    • CliniChat- new message notification.
    • Clinicians can see only their associated patients.
    • Clinicians will be logged out from the Web Portal after 1 hour (Instead of 15 min).

    Data portal version 1.12.0
    April 8, 2021

    • Digital Training Plan feature-
      • Clinicians can build and edit a personalized weekly plan for each patient, as well as tracking their compliance.
      • Patients can view and play sessions from their training plan directly from the VR headset.

    Data portal version 11.12.1
    May 11, 2021

    • New user role ‘Referring provider’, which lets referring providers to access the data portal and review their associated patients’ data and training plans (view only).

    Data portal version 1.12.2
    June 17, 2021

    • Technical support admin interface- clinicians’ pictures & videos upload.
    • CliniChat immediate SMS reminders for therapists who are not connected to the web portal during work hours.
    • Training Plan edit mode changes.
      • Unsaved changes in edit mode will be saved to the local cache.
      • The settings of the last session that was created are saved in the local cache, so they will be defined automatically when creating another session of the same app. 

    Data portal version 1.12.3
    August 05, 2021

    • Support for Reducept (a new third-party application) on Overview, Activities, and Dashboards.
    • Patients’ Chat with the office via CliniChat:
      New user role ‘Office’ which lets Full edit capabilities of patients & therapists within a specific organization, and Access to CliniChat as an office user.
    • CliniChat new abilities:
      • Delete message
      • Mark a message as delivered / read
      • Add patient details
      • Add search to the dialog list
  • Mobile app versions 1.7.1 (iOS) and 1.7.4 (Android)
    June 27 2022

    1. Added Braze SDK that will help us personalize your journey with XRHealth
    2. Resolved different bugs to make sure you have the best experience with XRHealth

    Mobile app versions 1.7.0 (iOS) and 1.7.0 (Android)
    April 21 2022

    1. A comfortable view of all therapy video appointments and VR exercises planned by patient’s therapist.
    2. Reminders to upcoming therapy appointments.

    Mobile app versions 1.5.11 (iOS) and 1.5.9 (Android)
    June 27 2021

    1. One time login
    2. Meet your personal therapist in a new onboarding experience
    3. Enhancements for chat with your therapist
    4. Friendly view and access to your training plan
    5. And as always… bug fixes…

    Mobile app versions 1.3.6 (iOS) and 1.3.9 (Android)
    October 10th 2020
    Clinichat! A new feature enabling patients to chat with their associated clinicians is now available!

  • Server Version 1.11.0

    October 11, 2020

    Support via API for Validate Token and Send workout session to XRHealth Servers

  • Any 6DOF Android Based Stand-alone VRH from Android version 10 and above

    Recommended XRHealth List

    Meta Quest 2, by Meta V.66 and above

    Meta Quest 3, by Meta V.66 and above

    Vive Focus Plus, by Vive System V 3.0 and above

    Pico Neo 2, by Pico PUI V 3.1.4 and above

    Pico Neo 3, by Pico PUI V 5.9.5.0 and above

    Pico G3, by Pico PUI V 5.9.5.0 and above

    Pico 4, by Pico PUI V 5.8.2 and above

Interested in learning more? Contact us

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Questions?
  • What is XRHealth?

    XRHealth is a pioneering platform and clinic at the intersection of healthcare and extended reality technology. It offers a suite of VR/AR therapeutic applications designed to enhance patient care through immersive experiences. These tools are used for a variety of health conditions, including mental health, physical rehabilitation, and cognitive improvement, providing both patients and providers with advanced options for treatment and therapy.

  • How does XRHealth work?

    Choose from our three core offerings: the eXperience Space platform for relaxation and mindfulness content, the Mental Health Space for supporting patients with a range of Mental Health concerns, and the Physical & Cognitive Space for addressing physical mobility, pain management, and cognitive rehabilitation.

  • What is Virtual Reality therapy?

    Virtual reality therapy is an innovative treatment approach using virtual reality technology to simulate environments for therapeutic purposes. It’s used to address a range of psychological and physical conditions by immersing patients in virtual scenarios that aid in treatment, rehabilitation, and recovery.

  • How can this help my facility?

    Research shows that virtual reality can be an effective tool for helping clinicians treat a variety of health concerns. The XRHealth platform is designed to be robust and versatile to meet the needs of your healthcare institution.

    Here are just a few of the benefits of the XRHealth platform:

    • Immersive VR environments help boost patient engagement and adherence to treatment plans, ultimately leading to better patient outcomes.
    • Help scale your clinician’s time and impact by giving patients relaxation and mindfulness exercises before or during procedures.
    • Measure and track patient progress.
    • Create treatment plans tailored to patient needs.
  • Is this a game?

    XRHealth utilizes engaging, interactive virtual environments that resembles game-like settings. However, this is a therapeutic tool designed to motivate, engage, and support patients in their treatment processes, using the principles of gamification to enhance adherence and outcomes.