FDA clears next-generation cardiac mapping software
San Diego-based Vektor Medical has gained an updated clearance from the U.S. Food and Drug Administration (FDA) for its vMap technology, which uses artificial intelligence (AI) to turn 12-lead electrocardiograms (ECGs) into 3D maps of the heart.
The company first secured FDA clearance for vMap in 2021. This update covers several enhancements, including atrial flutter mapping, direct ECG and data streaming through the use of electroanatomic mapping systems and more. It also now offers both local and remote connectivity, providing clinicians with multiple options when looking to securely exchange healthcare data.
Another key update is that vMap is now officially an FDA-cleared software as a medical device. This allows new users to implement the technology without needing custom hardware—they simply download the software onto their existing machines and they are ready to start evaluating patients.
“Receiving this new FDA clearance for our next-generation vMap is a major milestone for our product capabilities and reflects our continued focus on advancing vMap in ways that support electrophysiologists in their day-to-day work,” Rob Krummen, CEO of Vektor Medical, said in a prepared statement. “Connectivity is essential for scalability. By enabling more seamless data flow, we are helping EPs access arrhythmia insights faster to make informed decisions with greater confidence and support more efficient procedures, all of which contribute to better patient outcomes. We will begin rolling out the enhanced vMap technology to U.S. customers over the next several months extending the clinical and operational benefits of a more connected vMap.”
“This clearance represents another important milestone in integrating vMap more seamlessly into today’s connected EP ecosystem,” added Ben D’Souza, MD, associate professor of clinical medicine, section chief and director of the electrophysiology laboratory at Penn Presbyterian. “By enabling ECG data to move more freely and reliably into the mapping environment—and expanding its use to include atrial flutter—this update has the potential to further streamline EP lab workflows and make noninvasive mapping accessible to an even broader range of clinicians and patients.”
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.