Heart monitoring company iRhythm is in hot water with the Food and Drug Administration, which issued a stern warning letter to the device maker this week for marketing its product for “high risk” patients and changing its algorithm without seeking the FDA’s permission.
The letter highlights FDA’s growing scrutiny of digital health and patient monitoring tools — as well as the grave impacts even small device glitches can have on patients.
“Many developers consider the ease with which they can make changes to their software as a free pass, if you will,” said Jason Brooke, a medical device attorney and quality adviser. “This is a reminder that that’s not a free pass.”
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