HoloCare AS Announces Class I Medical Device CE Marking



Sopra Steria is proud to announce that HoloCare, holographic imaging leader, has successfully achieved Class I Medical Device CE Mark. HoloCare is equally owned by Sopra Steria and Inven2, Norway’s largest stakeholder in research marketing.

The achievement marks HoloCare’s first major regulatory milestone in its mission towards advancing the use of holograms in healthcare and surgical care. Derived from standard medical imaging, HoloCare’ s advanced imaging solutions allow for the translation of 2D to 3D imaging, thus improving anatomical visualization, and clinician communication and collaboration.

“This is a very important milestone for HoloCare and proofs that we are on the right track. I am impressed that we managed to achieve this in such a short time. Thanks to a persistent management and excellent cooperation between all parties involved, this is a fundament for the success of the company”, Solfrid Skilbrigt, Chair of the Board, HoloCare AS, said.

A key element in the company’s successful regulatory achievement stems from the positive collaboration between HoloCare and Devicia AB, an expert, full-service medical Clinical Research Organization team with extensive medical device experience within quality, regulatory and clinical affairs, in addition to AND Technology Research, a specialist’s team in technology management, design and V&V testing for medical devices.

Alison Sundset, CEO of HoloCare AS, said she is delighted with the collaboration of all the teams all achieved by digital remote communication.

“We have done this digitally across four countries. Managing to get over the finish line together as a collaborative team via digital platforms is a sign of these times, and I am so proud of all the HoloCare family, Oslo University Hospital, Devicia and AND TR. We did what looked like mission impossible in February this year. We set this goal and just pushed forward brick by brick laying the foundation of the roadway ahead with this milestone”, she said.

The story behind HoloCare goes back to the autumn of 2016 when Oslo University Hospital and Sopra Steria embarked on a groundbreaking research project to develop applications based on Microsoft’s HoloLens.

HoloCare is now a global platform based on cloud technology providing hospitals with accessibility and scalability, and integrating innovative technologies such as 3D, HoloLens 2 as well as holograms to prepare for major surgeries.