CardioFocus seeks PMA supplement to launch HeartLight X3 endoscopic ablation system

February 5, 2020 By Chris Newmarker

HeartLight Excalibur Balloon HeartLight X3 system CardioFocus AFib catheters AF — The HeartLight Excalibur Balloon used with the HeartLight X3 system. [Image courtesy of CardioFocus]

CardioFocus is seeking a PMA supplement with FDA so that it can launch its next-gen HeartLight X3 endoscopic ablation system in the U.S.

The move comes more than 10 months after Marlborough, Mass.–based won a CE Mark in Europe for the device, which is used to treat AFib. CardioFocus plans to launch HeartLight X3 in the U.S. immediately after receiving the PMA supplement, the company announced yesterday.

This supplement follows the original, approved PMA of the company’s HeartLight endoscopic system.

Get the full story on our sister site MassDevice.

About Chris Newmarker

Chris Newmarker is the executive editor of WTWH Media life science's news websites and publications including MassDevice, Medical Design & Outsourcing and more. A professional journalist of 18 years, he is a veteran of UBM (now Informa) and The Associated Press whose career has taken him from Ohio to Virginia, New Jersey and, most recently, Minnesota. He’s covered a wide variety of subjects, but his focus over the past decade has been business and technology. He holds bachelor’s degrees in journalism and political science from Ohio State University. Connect with him on LinkedIn or email at cnewmarker@wtwhmedia.com.