BardyDx Receives FDA 510(k) Clearance for 14-Day Carnation Ambulatory Monitor (CAM) Patch

Bardy Diagnostics, a leading provider of ambulatory cardiac monitoring technologies, announced today it received 510(k) clearance from the U.S. Food and Drug Administration ("FDA") for the 14-Day version of the Carnation Ambulatory Monitor ("CAM™"), the industry's only P-wave centric™ ambulatory cardiac patch monitor and arrhythmia detection device. Developed to provide clinicians greater flexibility in cardiac monitoring over a longer period, the award-winning CAM patch will now be offered in a 14-day extended wear version that utilizes the same innovative P-wave focused technology that powers the existing 2-Day and 7-Day CAM product lines

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Randy Scott