The company said analysis of its security protocol confirmed that advanced device security systems to protect patients are in place.

“St. Jude Medical stands behind the security and safety of our devices as confirmed by independent third parties and supported through our regulatory submissions,” the company said.

The medical-device maker’s comments follow a report by Muddy Waters Capital, which it says had seen demonstrations of cyberattacks against St. Jude devices, citing the work carried out by cybersecurity startup MedSec.

St. Jude Medical said it works with third-party experts, researchers, government agencies and regulators in cybersecurity to develop appropriate safeguards for its data and devices as part of its product development process and life cycle.

The experts assist the company in the design of security controls from the early stages of product design to final release and ongoing product improvements, including software updates and security patches for its products.

The company noted that it also undertakes regular risk assessments depending on FDA guidance and carry out penetration tests using internal and external experts.

It also collaborates with industry and governmental organizations to secure knowledge on recent trends and take suitable measures.

Image: St. Jude Medical global headquarters. Photo: courtesy of St. Jude Medical, Inc. (SJM).