Russian startup Diagnocat became the first Russian medical AI product for dentists to receive CE marking and the right to sell in Europe
On August 20, 2021 Diagnocat AI – AI service for dental imaging analysis – received CE marking (Class I). The CE marking is issued according to the requirements of the European Union as set out in European Regulation 2017/745 (Medical Device Regulation).
The CE marking confirms the compliance of the Diagnocat AI with the high safety, health and environmental protection requirements. Today Diagnocat AI is the only Russian medical software based on artificial intelligence that has received CE marking and the right for free circulation in the European Union and European Economic Area.
Diagnocat AI is an online service based on artificial intelligence that automatically analyzes dental X-rays (3D CBCT, Intraoral/FMX or panorama), determines the condition of the maxillary system, helps the doctor to make an accurate diagnosis and form a treatment plan. The accuracy of the analysis is over 90%*. Diagnocat is based on advanced technology of computer vision and was developed with participation of world leading experts (maxillofacial radiologists and dentists). Diagnocat for the patient is a second expert, objective and independent opinion on dental health.
Diagnocat minimizes the influence of human error. AI performs analysis faster and more accurately than most clinics currently do with “manual” description of the images by the doctor.
The most difficult part of our work is the interaction with the state registration authorities, which issue permits to sell medical devices on their territory. That is why it is so valuable that Diagnocat has received the CE mark and can now be used in clinical practice in the European Union! This is a real victory for the entire team.
— Vladimir Aleksandrovskiy (Alex Sanders), founder of Diagnocat, on receiving the CE mark
- 2017 – start of research and development of the technology (55 highly accomplished radiologists and dentists participated in the creation of the service).
- March 2019 – Diagnocat is presented at the 38th IDS World Dental Show in Cologne, Germany.
- 2021 – more than 200 dental clinics and diagnostic centers in Russia and CIS countries use Diagnocat.
- Diagnocat is currently in the process of getting FDA registration (United States Food and Drug Administration)
Diagnocat Scientific Papers
Clinically applicable artificial intelligence system for dental diagnosis with CBCT (22/07/2021)
- BMC Medical Imaging A deep learning approach for dental implant planning in cone-beam computed tomography images (19/05/2021)
- Journal of Stomatology, Oral and Maxillofacial Surgery
Evaluation of artificial intelligence for detecting impacted third molars on cone-beam computed tomography scans (February 2021)
- International Endodontic Journal
Evaluation of artificial intelligence for detecting periapical pathosis on cone-beam computed tomography scans (10/01/2020)
- Oral Health
Artificial Intelligence and Deep Learning in Dental Radiology: A Way Forward in Point of Care Radiology (10/12/2019)
- Аlex Sanders – President & Founder, PhD, DMD (instagram.com/dr_alex_sanders )
- Matvey Ezhov – Chief Technology Officer, Co-founder ([email protected])
- Evgeniy Shumilov – Chief Operating Officer, Co-founder ([email protected])
* Results were obtained from pilots at Dental Fantasy and Belgravia Dental Studio clinics in Moscow (over 20,000 patients, 2019-2020)