NYT Report: Apple Watch ‘ should not be considered a medical device ’

The new electrocardiogram-equipped Apple (NSDQ:AAPL) Watch should not be considered a medical device, according to a new report from the New York Times. The article, written by Indiana University School of Medicine pediatrics professor Aaron Carroll, calls into question the downsides of the newly released device and the potential for both false positives and false negatives. Carroll acknowledged the possible positives of the device, including the ability for physicians to monitor patients from a distance and diagnosing heart problems in individuals that would possibly go undetected, but said that “just because something seems like a good idea doesn’t mean it is.” “No screening test is perfect,” Carroll wrote in the Times article. “In general, we would like people who are sick to have a positive screening result, and people who are well to have a negative result. Unfortunately, people who are sick sometimes have a negative result. Those are false negatives. People who are well sometimes have a positive result. Those are false positives.” Both outcomes are worrisome, Carroll suggested in the report. He added the false negatives may cause someone who needs medical help to not seek it, but said that because “relatively few people have serious, undiagnosed arrhythmias with no symptoms” that it wasn’t a major concern. False positives, however, end up costing time time, money and emotional distress, according to the Times report. ...
Source: Mass Device - Category: Medical Devices Authors: Tags: Business/Financial News Diagnostics mHealth (Mobile Health) Apple Source Type: news