The TBS iNsight system calculates the bone mineral density (BMD) to determine bone fragility in patients with osteoporosis. Image Credit: sdecoret / Shutterstock.

Switzerland-based Medimaps Group has received the Medical Device Regulation (MDR) certification for continued European Union marketing of its management system and product portfolio.

The new more comprehensive and stringent EU MDR regulations came into effect in 2020, with the transition period lasting until 2027 for high-risk devices and 2028 for medium and low risk devices. These have since been a point of contention with companies stating that new regulations suppress early device development.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

Medimaps’ chairman of the board of directors Meinhard F Schmidt described the new MDR as a ‘complex regulatory process’ that took the company two years to execute.

Medimaps’ CEO Didier Hans said: “We are very proud to be one of the earliest artificial intelligence (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 company’s product portfolio includes the AI-powered processing software, TBS iNsight. The software can be integrated into dual-energy X-ray absorptiometry (DXA) scanners, and/or X-rays and CT PACs (picture archiving and communication system) systems. It has been approved for use in multiple countries, including the US.

See Also:

The TBS iNsight system calculates the bone mineral density (BMD) to determine bone fragility in patients with osteoporosis. It also provides deep-tech bone texture analysis that helps determine osteoporosis management.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

AI-powered X-ray and image-processing software development has ramped up in recent years. In August 2023, the US Food and Drug Administration (FDA) approved an AI-powered medical device, VisiRad XR, that analyses chest X-rays for potential lung nodules and masses.