Swiss medical technology company Medimaps Group has secured the Medical Device Regulation (MDR) certification for its management system and product portfolio from the European Union’s notified body BSI (CE 2797).
Following the certification, Medimaps Group can continue offering certified TBS iNsight (Osteo) software at the highest standard to its customers in Europe and other areas.
TBS iNsight is a medical image processing device that has been designed to measure bone mineral density (BMD) for the detection of bone fragility in osteoporosis patients.
According to Medimaps, its flagship device can be integrated seamlessly into dual-energy X-ray absorptiometry (DXA) scanners, and/or X-rays, and CT PACs systems.
Its software is said to offer a deep tech analysis of bone texture related to bone micro-architecture using a Trabecular Bone Score (TBS).
Medimaps stated that the software complements BMD measuring and clinical risk factors to improve osteoporosis management without additional testing or radiation, the Swiss firm said.
Medimaps co-founder and CEO Didier Hans said: “We are very proud to be one of the earliest AI companies to achieve the MDR certification.
“By successfully navigating the rigorous requirements of the Medical Device Regulation, our company proves its ability to deliver innovative and reliable solutions that meet the highest regulatory standards for the benefit of patients, healthcare professionals and medical business partners.”
The TBS Osteo software is said to be simple to install on a DXA machine and uses the DXA 2-D pictures created during a standard spine BMD scan to accurately calculate a patient’s TBS.
The results are presented in an automated report that can be edited, is simple for medical professionals to understand, and doesn’t involve any additional radiation or patient scan time.
The CE marked and US Food and Drug Administration (FDA)-approved TBS iNsight is commercially available in 60 countries.
