Artfun+ Receives EU MDR Class 2a Approval for Medical Device.
Artfun+, powered by Imageens, has received Class 2a approval under the EU’s new Medical Device Regulation (EU MDR), becoming the world’s most clinically validated device measuring MRI imaging biomarkers related to arterial stiffness and cardiovascular diseases. This breakthrough promises to transform cardiovascular risk assessment for clinicians worldwide.
Cardiovascular diseases are a global cause of mortality, emphasizing the need for accurate and timely diagnosis. Traditional risk assessment methods are labor-intensive and prone to errors. ArtFun+ harnesses AI and medical imaging for precise risk assessments.
Artfun+ is an AI-powered tool analyzing MRI scans to identify specific biomarkers linked to cardiovascular diseases. By accurately measuring these markers, Artfun+ equips healthcare professionals with vital information for tailored treatment plans.
The Class 2a approval demands rigorous validation, making Artfun+ a reliable and clinically validated tool for the medical community. This certification sets a new benchmark for AI-driven healthcare solutions, paving the way for future innovations in medical imaging.
Anas Dogui, Ph.D., CEO at Imageens, expresses excitement about this achievement, validating Artfun+’s exceptional performance and clinical relevance. The mission is to provide accurate tools for data-driven decisions and improved patient outcomes.
“By enabling accurate measurement of MRI imaging biomarkers, Artfun+ promises to revolutionize cardiovascular care and significantly impact patient outcomes. This achievement highlights AI-driven medical imaging solutions’ potential in improving healthcare and saving lives.”
About Imageens:
Imageens is a Paris-based Healthtech company founded in 2017, focusing on the prevention and early diagnosis of cardiovascular diseases (CVD). Since its inception, Imageens has been immersed in international DeepTech and established with the goal of developing market-ready medical image processing software based on over 10 years of technical and clinical research conducted by world-class research institutions such as Sorbonne Université, the AP-HP, and Johns Hopkins.
From the outset, Imageens has demonstrated its capability to harness advanced AI in creating cutting-edge medical software. This innovation has earned recognition through several prestigious French innovation competitions and multiple innovation labels.
Today, Imageens leads the charge in the rapidly growing field of AI in cardiovascular health and medical imaging. The company possesses the world’s most clinically validated technology for analyzing arterial function through MRI, deploying this technology alongside other AI components to revolutionize treatment decisions in cardiovascular health and beyond. Learn more at www.Imageens.com.
