FDA warns Abbott to fix medical device problems
The Food and Drug Administration sent a warning letter to St. Jude Medical and its parent company Abbott Laboratories this week demanding the medical device manufacturer fix longstanding troubles with its heart devices and in-home heart monitoring system, the Minneapolis Star Tribune reports. The FDA found problems with the devices' batteries, which led to an unreported death, as well as "cybersecurity vulnerabilities" with the monitoring system.
Why this matters: Abbott bought St. Jude Medical in a $25 billion deal this past January, further consolidating the medical device industry. Critics have argued that medical device malfunctions aren't being tracked closely enough, which puts patient safety at risk.