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.
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.
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.
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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.