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Sweden’s Coala Life Gets FDA Clearance for Heart Monitor

Feb. 14, 2019, 2:31 PM

Coala Life AB has received clearance from the U.S. Food and Drug Administration for the Coala Heart Monitor, a medical system that records heart sounds and ECG.

  • The company, whose investors include Elekta AB Chairman Laurent Leksell and former Industrivarden AB Chief Executive Officer Anders Nyren, will now “scale up into the U.S. market,” according to an emailed statement on Thursday.
  • The Coala Heart Monitor has an integrated stethoscope and ECG electrodes, avoiding the need of sticky patches, according to the company. It analyzes the recordings with algortithms to provide results in seconds, it said.
  • According to the Centers for...

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