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The agency “should be focused on ensuring it has the tools and capacity to guarantee that software products that perform medical device functions are safe and effective and to hold companies that skirt the rules accountable,” the letter states. Read More
The FDA has released guidance for sponsors of devices with cybersecurity risks on what they should include in their premarket submissions, as well as considerations for device design and labeling. Read More
The potential for threats and vulnerabilities rises with increased medical device innovation and integration with hospital networks and technology. Read More
The programmer software can be updated either through an internet connection to the Medtronic Software Distribution Network or by a Medtronic representative plugging directly into the device. Read More