The U.S. FDA has recalled certain Medtronic MiniMed insulin pumps due to potential cybersecurity risks and recommends that patients using these devices switch their insulin pump to models that are better equipped to protect against these potential risks.
Read More
The FDA is taking steps to update its Medical Device Reporting (MDR) Program, one of the tools the agency uses to monitor device performance, detect potential device-related safety concerns or signals, and contribute to the benefit-risk assessment of these products.
Read More
Cybersecurity provider CSPi and Seceon have linked up to develop a product to address one of the biggest security challenges related to the Internet of Things (IoT): where endpoint detection and response applications and other bolt-on security services cannot be deployed on IoT devices.
Read More
After months of debate regarding the difference between medical device servicing and remanufacturing, the U.S. FDA is planning to publish a draft guidance document on the subject by September 30, an official for the agency revealed during AAMI Exchange 2019.
Read More
In May, a manufacturer of a non-OEM AED replacement battery received a Warning Letter from the FDA, following an inspection that occurred last November. Here, educator William Hyman breaks down the implications this could have for the industry.
Read More