Body Vision Medical, a leader in AI-driven intraoperative imaging announced today that its latest generation LungVision™ AI-powered lung navigation and real-time imaging platform has been granted certification as a Class IIa medical device under the European Union Medical Device Regulation (Regulation (EU) 2017/745) (EU-MDR). The certification, issued by mdc medical device certification GmbH on September 18, 2023, makes Body Vision the first company worldwide in the industry of lung navigation and real-time imaging to obtain the new European Medical Device Regulation (MDR) Certification recommendation.
Over the past several years, regulations for medical device manufacturers have become progressively more complex and demanding. In Europe, the transition from MDD (Medical Device Directives) to MDR (Medical Device Regulations) has brought increased quality and regulatory demands, including the requirement for additional clinical evidence supporting safety and efficacy.
“The EU-MDR is one of the world’s most robust health tech regulations and plays a vital role in ensuring medical devices meet the highest standards,” said Matt Baker, Chief Operating Officer for Body Vision Medical. “Receiving EU-MDR certification for LungVision™ reflects our team’s commitment to delivering medical solutions that exceed the most exacting standards for healthcare technologies and gives confidence to European clinicians and healthcare institutions who are looking to offer our transformative lung nodule biopsy technology to their patients.”
LungVision™ harnesses the power of artificial intelligence (AI) to seamlessly transform X-ray images acquired from any C-arm into real-time intraoperative CT scans. This groundbreaking technology empowers bronchoscopists with the ability to visualize pulmonary lesions in real time during diagnostic bronchoscopy. By significantly augmenting the accuracy and precision of lung nodule biopsies through image guidance, LungVision™ has the potential to enable earlier-stage cancer detection and improve lung cancer survival rates.