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.”
This article is exclusive to STAT+ subscribers
Unlock this article — and get additional analysis of the technologies disrupting health care — by subscribing to STAT+.
Already have an account? Log in
Already have an account? Log in
About the Author Reprints
To submit a correction request, please visit our Contact Us page.
STAT encourages you to share your voice. We welcome your commentary, criticism, and expertise on our subscriber-only platform, STAT+ Connect