Clinicians inspecting heart hologram

Clinicians inspecting heart hologram

PUBLISHED 10.06.2021

HoloCare AS Announces Class I Medical Device CE Marking

OSLO, Norway; June 2nd, 2021—Holographic imaging leader, HoloCare AS, is proud to announce the achievement of successful Class I Medical Device CE Mark. Today marks the company’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 persistant 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

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

!I am delighted with the collaboration of all the teams, all achieved by digital remote communication in and from 4 countries – a sign of these times and managing to get over the finish line together as a collaborative team via digital platforms – I am so proud of all the HoloCare family, Oslo University Hospital, AND TR and Devicia – 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.

Alison Sundset, CEO, HoloCare AS

About HoloCare AS:

The company HoloCare AS is a result of Inven2, Norway's largest player in the commercialisation of research, and the consultancy Sopra Steria joining forces to create a medical device company with a focus on the use of holographic in healthcare, HoloCare AS is developing a platform based on “Mixed Reality" holographic solutions which could significantly improve patient care, pre/surgical planning and aid to improved remote therapy. The solutions will be launched in a global market.

About Devicia AB:

Devicia is your full-service partner offering regulatory and clinical expertise for medical devices. As members of the technical committees’ writing medical device standards, Devicia are always up-to-date with the latest news and regulations and take part in the process of decision making. Devicia has offices in Sweden and the United States.

“Working with HoloCare AS on transcending years of research and development into products that meets EU demanding regulatory requirements has been very stimulating. Holocare’s timing in bringing their medical device software to the market is impeccable, as it will address several important unmet medical needs. We are very excited about continued collaborations with Holocare"

Elisabeth Liljensten, CEO Devicia

About AND TR: 

AND Technology Research is a pioneering, purpose-led technology company working to improve efficiency, sustainability, and innovation around the world. AND’s work has already helped over 250 customers worldwide to build scalable, robust, disruptive digital products. They recently launched their flagship online tool, Tento, which streamlines the testing process within regulated markets, and simplifies the regulatory pathway to certification. Paired with AND’s 40 years of experience, Tento brings medical products to market safely, quickly and more effectively.

“At AND, we love working on exciting and innovative projects, and none more so than with HoloCare! The talented team of researchers and developers at Sopra Steria have created a wonderfully innovative solution to some of the most challenging areas in medicine. It has been a real pleasure working with everyone to bring this project to market and we cannot wait to see where the project can go next.”

Nicola Thorn, CEO AND Technology Research

 

Contact Details:

Solfrid Skilbrigt, Sopra Steria: solfrid.skilbrigt@soprasteria.com

Alison Sundset, HoloCare AS: alison.sundset@holocare.com

 

Find the Norwegian article here: http://pressenytt.no/nor/Artikler/Teknologi/HoloCare-med-viktig-milepael

 

MEDIA

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