Last month the FDA cleared iRhythm’s Zio Watch wearable with Google healthcare software company Verily’s ZEUS (Zio ECG Utilization Software) for monitoring heart rhythms. We weren’t surprised to learn about the FDA clearance and fully expect other wearables to get the FDA nod for monitoring atrial fibrillation (AFib) and atrial flutter. Health Tech Insider has covered iRhythm’s wearable cardiac monitoring technology since 2014. In mid 2021, I wore a cardiologist-prescribed ZioPatch monitor for 14 days to track my own arrythmia. Any time the wearable detected my heartbeat was out of order it sent an alert and a report to my doctor. When I eventually read the results of the two-week test I was surprised to discover how often my heart had been acting up. I recently met with an electrophysiologist (a cardiologist who specializes in heart rhythm disorders) who considered the previous year’s ZioPatch report an important factor in his diagnosis and prescribed treatment plan.
So it’s no surprise to me that a recent Massachusetts General Hospital study published in JAMA Health Forum found wearable AFib devices are a cost-effective method for screening heart rhythm disorders. Specifically, the Mass General team showed that wrist-worn AFib screening was cheaper than conventional 12-lead ECGs and taking a person’s pulse. Further findings included a reduction in the incidence of strokes with people who used wrist-worn monitoring devices. Because a hospital ECG is a one-time report, wrist-worn devices that continuously monitor heart rhythm can detect AFib episodes that occur less frequently.
The researchers tested six different wrist-worn wearables. The wearables devices employed photoplethysmography (PPG), single-lead ECG, or both technologies. The researchers also tested pulse palpation and conventional 12-lead ECG screening for AFib cost-effectiveness. The team evaluated the eight alternatives using a 30-million person simulated test group of people 65 and older. Among the eight tested AFib screening technologies, the PPG wrist-wearables were deemed the “economically preferred” choice. The second most economical technology was wrist-worn ECG devices when followed up with a two-week test using a clinical-grade rhythm monitoring smart patch (such as the ZioPatch I used last summer).
So, this study is another win for wearables, especially for evolved FDA-approved wearables that produce clinical-grade results.