The regulatory nod marks the second this week for wearable ECG technology. Samsung spinoff Wellysis picked up FDA clearance for its own ECG patch on Sept. 13.
Lausanne, Switzerland-based SmartCardia designed its easy-to-wear, cable-free, waterproof patch for up to 14 days of continuous monitoring.
“SmartCardia’s 7L patch and cloud platform is a single solution that covers the entire spectrum of cardiac monitoring including screening, post-operative follow-up, and remote patient monitoring,” said Srinivasan Murali, co-founder and CEO of SmartCardia. Murali said its ground-up design aims to meet the stringent requirements of these different applications.
With seven leads, the patch overcomes what SmartCardia calls “one of the major limitations of cardia…