Disior, a medical technology company focused on the development and commercialization of analytics software for medical doctors, announced it has received CE Mark approval (Medical Device Class IIb) for the foot and ankle analysis application.
“The CE mark approval is a significant milestone for Disior as it required thorough regulatory review against high clinical and safety standards”, said Anna-Maria Henell, CEO of Disior. “This is an important leap forward for our company, as we are bringing to market a novel and automated tool for analysing radiographic angles, measurements and reference points that we are confident will benefit both healthcare providers and patients.” This certification confirms that the product meets the international standard (ISO 13485:2016) for designing, developing, manufacturing and selling medical software for diagnostics and treatment planning. Disior, developing analytics software for medical doctors, announced that it has achieved ISO 13485:2016 certification for Medical Device and Quality Management Systems. This certification is an international standard outlining the requirements for a quality management system specific to the medical device industry. ISO 13485:2016 is specifically focused on the requirements for a comprehensive quality management system for designing, developing, manufacturing and selling medical software for diagnostics and treatment planning.
Attaining an ISO 13485:2016 certificate officially makes Disior a trustworthy business partner capable of providing safety, reliability and superior quality in the development of software solutions for medical devices. Disior’s Juha Tampio one of the co-authors of a new research paper accepted for publication6/5/2020
Juha Tampio, Principal developer at Disior, was a co-author in a research paper accepted for publication in the Clinical Anatomy.
Juha, together with researchers from the Department of Hand Surgery at University of Helsinki and Helsinki University Hospital (Finland), applied mathematical modelling to study the anatomy of the distal radius to define the radiographic parameters in a 3D imaging modality, and to report their normal ranges in the uninjured radius. The authors identified that the optimal location for determining the longitudinal axis was between 28.8 mm and 53.3 mm proximally from the articular surface, the mean radial inclination angle was 21.8°, and the mean volar tilt angle via the most distal tips of the volar and dorsal rims was 13.0°. The authors further indicate how computer-aided medical image processing offers an advanced tool to record 3D geometry and the radiographic parameters of the bony structures of the wrist. We are proud of you, Juha. Congratulations to you and the entire research group on a great work done! Further information on the publication: Suojärvi N, Tampio J, Lindfors N, Waris E, Computer‐Aided 3D Analysis of Anatomy and Radiographic Parameters of the Distal Radius, Clinical Anatomy (2020), doi: https://doi.org/10.1002/ca.23615 Valtteri Lehtinen, 5th year dental student working on his PhD and a data analyst at Disior, got his research paper accepted for publication in the Journal of Oral and Maxillofacial Surgery.
Valtteri together with his research colleagues from the Department of Oral and Maxillofacial Diseases at University of Helsinki and Helsinki University Hospital (Finland) studied the relationship between the amount of dislocation in zygomatico-orbital fractures, etiology and surgical treatment using a novel automated algorithm for measuring the dislocation of fracture. With a sample of 115 subjects Valtteri et al. identified a significant association between mean amount of dislocation and operative treatment. The researchers indicate that the zygomatic fractures are more likely to be diagnosed as dislocated and to be operatively treated when mean dislocation exceeds 2mm being at the limits of human eye detection. We could not be any prouder of you, Valtteri. Congratulations on the job well done to you and the entire research group! Valtteri’s research is a great example how academic research can benefit from gaining awareness of novel technologies developed. We at Disior were delighted to provide an in-house developed algorithm for the research group and to see how the researchers were able to utilise it in analysing zygomatico-orbital fractures. Sometimes working with R&D companies may provide a possibility to innovate on what is possible with the research. Further information on the publication: Lehtinen V, Pyötsiä K, Snäll J, Toivari M, Zygomatico-Orbital Fracture-Dislocation in Surgical Treatment: Novel 3-Dimensional Software Automated Analysis, Journal of Oral and Maxillofacial Surgery (2020), doi: https://doi.org/10.1016/j.joms.2020.03.016 On January 8th, Disior welcomed Professor Andrii Kopchak and associate professor Dr. Yurii Chepurnyi from Bogomolets National Medical University Department of Stomatology - known for their work with orbital defects and deformities as well as using custom-made patient-specific implants in medical research. From Imateh Medical LLC - an individualized implant manufacturing company, Disior had the pleasure of welcoming Mr. Dan Prykhodko and Mr. Denys Chernohorskyi. The meeting consisted of conversations about the software for orbital analysis and discussions on other maxillofacial areas - including a short meeting with Professor Risto Renkonen, Dean of the Faculty of Medicine, University of Helsinki. Clinical discussions were led by Professor Risto Kontio from Maxillofacial Department, Helsinki University Hospital. Our guests visited the headquaters of Planmeca as well - one of the world's leading manufacturers of dental technology. Disior and The University Hospital of Kiev initiate a collaboration through a research project utilising Disior’s Bonelogic CMF Software. Disior's Bonelogic CMF Orbital Software provides automated analysis of orbital fracture, shape and size with virtual reconstruction and patient-specific implant design. It could be used for accurate evaluation of the orbital injury and provide extremely accurate measurements of the orbital volume and its changes.
From the global launch of Bonelogic Ortho Foot and Ankle Software, to having new members joining our team – Fall 2019 has been a big success! Disior's fall 2019 started with preparations to launch the Bonelogic Ortho Foot and Ankle Software, which was launched at 50th anniversary and annual meeting of American Ortho Foot and Ankle Society in Chicago On September 12th. Years worth of work and intensive medical research combined with advanced technology and co-operation with various professionals resulted as a novel innovation - with a goal to bring the "full 3D vision" to doctors. We had the pleasure of meeting the most inspiring professionals in foot and ankle field during some of the biggest industry events and had the chance to demonstrate how advanced technology can be the most beneficial in clinical use. Best of Both Worlds Our most valuable asset from the very beginning has been the combination of clinical experience and knowledge with latest software technology. Our goal is to bring truly valuable and useful tools to the medical field by doing what we are best at - advanced software algorithms and technology. This approach has helped us to build a software from doctors to doctors. As a growing company in medical technology we are proud and excited to present our work to the industry in various events as well as help other companies with beneficial solutions for the clinical world. During the fall of 2019 we participated in various discussions and hosted some of our own as well. Continuous learning and connecting with the professionals in our field - medical and technical - is something that we are looking forward in 2020. Disior Team is Growing It all comes down to the team. In hospital, surgery room or in a software company office - teamwork is what counts. Disior is a multi-professional team which doubled its size from last year. We expect to continue growing and look forward to have new professionals join our mission of making medical imaging intelligent. Disior wishes you Happy Holidays and Best Wishes For 2020!
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