EU-MDR Certification Granted to Body Vision Medical's LungVision™ AI-Enhanced Image Guidance Solution
Wednesday, September 20, 2023
Body Vision Medical, a leading innovator in AI-driven intraoperative imaging, proudly announces a significant achievement today. The latest-generation LungVision™ AI-powered platform, tailored for lung navigation and real-time imaging, has obtained certification as a Class IIa medical device under the European Union Medical Device Regulation (EU-MDR). In a groundbreaking move, Body Vision Medical becomes the pioneer worldwide in the field of lung navigation and real-time imaging to secure EU-MDR Certification.
In recent years, the regulatory landscape for medical device manufacturers has undergone a transformation, with growing complexity and demands. The transition from Medical Device Directives (MDD) to the more rigorous Medical Device Regulations (MDR) in Europe has introduced heightened quality and regulatory requirements. These include the need for substantial clinical evidence to support safety and efficacy. EU-MDR ranks among the world's most stringent health tech regulations, ensuring that medical devices adhere to the highest standards.
The attainment of EU-MDR certification for LungVision™ underscores the unwavering commitment of the Body Vision Medical team to deliver medical solutions that surpass the most rigorous standards in healthcare technology. This achievement instills confidence in European healthcare providers and institutions keen on offering this groundbreaking lung nodule biopsy technology to their patients.
LungVision™ leverages the power of artificial intelligence (AI) to seamlessly transform X-ray images acquired from any C-arm into real-time intraoperative CT scans. This pioneering technology empowers bronchoscopists with the remarkable ability to visualize pulmonary lesions in real-time during diagnostic bronchoscopy. By significantly enhancing the precision and accuracy of lung nodule biopsies through advanced image guidance, LungVision™ holds the potential to facilitate early-stage cancer detection and potentially improve lung cancer survival rates.