Abbott releases firmware upgrade for certain cardiac devices

19 April 2018 (Last Updated April 19th, 2018 15:15)

Abbott has released a firmware update for some of its high-voltage implantable cardiac devices to enhance cybersecurity and improve battery performance.

Abbott has released a firmware update for some of its high-voltage implantable cardiac devices to enhance cybersecurity and improve battery performance.

The upgrade is part of the medical device company’s planned series of updates and covers devices that were recalled in 2016.

Firmware is a form of software embedded in medical devices and is now available for Abbott’s implantable cardioverter defibrillators (ICDs) and cardiac resynchronisation therapy defibrillators (CRT-Ds), which are designed to provide pacing and/or electrical shock when necessary.

The software was approved by the US Food and Drug Administration (FDA) on 11 April.

“The upgrade is part of the medical device company’s planned series of updates and covers devices that were recalled in 2016.”

It offers a device-based battery performance alert to allow monitoring and management of the battery. In case of ‘abnormal battery behaviour’, the firmware sends notifications to the patient.

The cybersecurity update included in the software is set to provide an additional layer of protection against unauthorised device access, preventing unapproved/illegal changes to the device settings.

However, the company said that it did not receive any reports of unauthorised access and detected no new vulnerabilities to its implanted devices.

Abbott Medical Devices executive vice-president Robert Ford said: “Technology and its security are always evolving, and this firmware upgrade is part of our commitment to ensuring our products include the latest advancements and protections for patients.”

The ICD and CRT-D device ranges eligible for the new upgrade include Fortify, Fortify Assura, Unify, Quadra Assura, Unify Quadra, Quadra Assura MP and Unify Assura.

In addition, the cybersecurity update is available for the Promote Quadra and Ellipse families.

Abbott noted that it is working with regulatory authorities to roll out the upgrades over the coming several weeks.