Smartwatch Now Cleared for AFib Detection

Smartwatch Now Cleared for AFib Detection

Fitbit recently announced that the Fitbit ECG App now has both FDA 510(k) clearance and CE marking to analyze user heart rhythm for atrial fibrillation (AFib). The new Fitbit Sense smartwatch — available now — is the first Fitbit wearable with the ECG App....
Withings ScanWatch [video]

Withings ScanWatch [video]

We’ve written about Withings multiple times on Health Tech Insider. We covered Withings’ wearables including smartwatches, smart scales, blood pressure monitors, ECG watches, temperature monitors, sleep aids, and more. We tracked Nokia’s acquisition...
Omron Complete Blood Pressure and EKG Monitor

Omron Complete Blood Pressure and EKG Monitor

Omron Healthcare has long been a standard for clinical and consumer blood pressure monitors. At CES 2018, Omron introduced the HeartGuide smartwatch built around an oscillometric blood pressure monitor (the type that squeezes your arm) with a companion smartphone app...
Eko Scores FDA Breakthrough Device Designation

Eko Scores FDA Breakthrough Device Designation

This time it’s the software. We’ve written numerous times about Eko’s Duo digital stethoscope. Last week the FDA granted Breakthrough Device status to the artificial intelligence algorithm designed to detect heart failure. The designation is granted...