US FDA Permits AliveCor's AI Mobile ECG To Measure QTc In COVID-19 Patients

AliveCor wins US FDA permission to use its mobile ECG to detect heart problems caused by drugs to treat COVID-19 patients.

Heart disorder and atrial fibrillation ecg as a coronary cardiac attack with irregular and normal organ rhythm as a chest discomfort disease concept in a 3D illustration style.

AliveCor Inc., which markets a six-lead consumer electrocardiography (ECG) device called KardiaMobile 6L for at-home use and in clinical settings to detect heart arrythmias, announced yesterday that the US Food and Drug Administration permitted an expanded use of the device to detect prolonged heartbeats caused by medications used to treat COVID-19.

The announcement follows a new guidance issued by the FDA on 20 March that allows manufacturers of patient-monitoring devices to...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Approvals

More from Policy & Regulation