No. According to the product documentation, GalaPsy Pro is not classified as a medical device. Medical licensing requirements for its use depend on local legislation.
Medical devices are instruments, apparatus, equipment, materials or other products, including software required for their intended use, that the manufacturer intends for use in people to:
- diagnose, prevent, monitor, treat or alleviate disease;
- diagnose, monitor, treat, alleviate or compensate for injury or disability;
- investigate, replace or modify anatomy, or support physiological functions;
- control conception.
GalaPsy holds a 2025 patent for a method of conducting an eye movement desensitisation session using virtual reality and artificial intelligence technologies (IPC A61B5/16, G10H2/00, G06T13/40, G06F111/18).
The documentation describes this method as an automated version of an EMDR-based psychological intervention. GalaPsy Pro comprises a VR headset and the software described in the patent.