https://www.fda.gov/medical-devices/safety-communications/sweyntooth-cybersecurity-vulnerabilities-may-affect-certain-medical-devices-fda-safety-communication?utm_campaign=SweynTooth%20Cybersecurity%20Vulnerabilities%20May%20Affect%20Certain%20Medical%20Devices&utm_medium=email&utm_source=Eloqua

SweynTooth Cybersecurity Vulnerabilities May Affect Certain Medical Devices

The U.S. Food and Drug Administration (FDA) is informing patients, health care providers, and manufacturers about the SweynTooth family of cybersecurity vulnerabilities, which may introduce risks for certain medical devices. The FDA is not aware of any confirmed adverse events related to these vulnerabilities.  The SweynTooth vulnerabilities are associated with a wireless communication technology known as Bluetooth Low Energy (BLE). BLE enables two devices to “pair” and exchange information to perform their intended functions while preserving battery life. The FDA is currently aware of several system-on-a-chip (SoC) manufacturers that are affected by these vulnerabilities:  The safety communication provides important information about these cybersecurity vulnerabilities, including: Details on the vulnerabilities and how medical devices may be affected. Recommendations for manufacturers, health care providers, health care facility staff, and patients and caregivers. Instructions for reporting problems with a device.

Read the Safety Communications Questions? If you have questions about this safety communication, contact the Division of Industry and Consumer Education (DICE).