Le Lézard
Classified in: Health, Science and technology
Subject: IMA

Body Vision Medical Receives EU-MDR Certification for LungVisiontm AI-Powered Image Guidance Platform

LungVisiontm becomes the first and only lung navigation and real-time imaging platform to be certified under EU-MDR

CAMPBELL, Calif., Sept. 19, 2023 /PRNewswire/ -- Body Vision Medical, a leader in AI-driven intraoperative imaging announced today that its latest generation LungVisiontm 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 LungVisiontm 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."

LungVisiontm 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, LungVisiontm has the potential to enable earlier-stage cancer detection and improve lung cancer survival rates.

To learn more about Body Vision Medical, visit bodyvisionmedical.com.

About Body Vision Medical
Body Vision Medical specializes in AI-driven, intraoperative imaging with the aim of saving lives through the democratization of innovative medical technology. Its first commercial product, LungVisiontm, addresses the unmet clinical need for early, definitive lung cancer diagnosis and, in the future, to enable effective treatment of lung lesions via a minimally-invasive procedure.

Visit bodyvisionmedical.com to learn more and connect with them on LinkedIn.


SOURCE Body Vision Medical

These press releases may also interest you

at 02:16
Crayon, a global leader in innovation and IT services, today announced the renewal of its Microsoft Azure Expert Managed Service Provider status. This accomplishment reaffirms Crayon's ability to adapt to business landscapes and consistently deliver...

at 02:15
The "Hosting Infrastructure Services Market by deployment (Cloud and On-premises), end-user (BFSI, IT and telecommunication, Government, Retail and e-commerce, and Manufacturing and others), and geography (North America, Europe, APAC, Middle East and...

at 02:14
CINNOX, a trailblazer in global enterprise communication and collaboration platform, today announced the launch of its groundbreaking CINNOX Virtual Assistant, a pivotal innovation designed to unleash the full potential of the businesses at The...

at 02:05
The Vaudoise Insurance Group (Vaudoise), one of the leading private Swiss insurers, and Guidewire announced that Vaudoise has chosen Guidewire InsuranceSuite operating on Guidewire Cloud to power its core operating systems. Vaudoise will implement...

at 02:05
Healiva®, a patient-centric company delivering life-enhancing precision medicine for chronic wounds, announced today a strategic collaboration with Lausanne University Hospital (CHUV, ?Centre Hospitalier Universitaire Vaudois') for the manufacturing...

at 02:05
Access4you provides detailed and reliable information on the accessibility of the built environment for people with disabilities and property owners. The Social Impact startup, founded in 2019, has a unified signage system that can help target groups...

News published on and distributed by: