FDA Archives

14,000 medical devices are online, unsecured and vulnerable

Censys cybersecurity researchers find medical devices, login portals, and health records floating online.

Oct 10, 2024 By Christian Vasquez

A surgeon implants a pacemaker into a patient in an operating room on July 19, 2013 at the Argenteuil hospital, in a Paris suburb. (FRED DUFOUR / AFP)

FDA cyber mandates for medical devices goes into effect

The Biden administration is pushing the manufacturers of medical devices to take on greater responsibility to ensure that they are secure.

Oct 2, 2023 By Christian Vasquez

A healthcare worker tends to a patient on a ventilator in the Intensive Care Unit of Baptist Health Floyd on September 7, 2021 in New Albany, Indiana. (Photo by Jon Cherry/Getty Images)

Senators push for more frequent medical device cybersecurity guidance from FDA

Cybersecurity threats against health care have skyrocketed in recent years.

Jun 3, 2022 By Tonya Riley

Researchers show how to tamper with medication in popular infusion pumps using software flaws

The research illustrates the challenge of securing devices conceived decades ago from 21st-century digital threats.

Aug 24, 2021 By Sean Lyngaas

BlackBerry’s popular operating system for medical devices affected by critical vulnerabilities, drawing fed warnings

The disclosure expands the number of devices that could be at risk due to the "BadAlloc" flaw.

Aug 17, 2021 By Sean Lyngaas

COVID-19 cybersecurity — The Health Information Sharing and Analysis Center (H-ISAC), whose members include big health care providers, has already received threat alerts from the volunteer group. (Getty Images)

All hands on deck: Infosec volunteers to protect medical organizations during COVID-19 crisis

By day, they are cybersecurity professionals at well-known companies. By night, they are working to protect health organizations from hackers.

Mar 20, 2020 By Sean Lyngaas

fda advisory — The set of flaws in a popular wireless protocol known as Bluetooth Low Energy could impact glucose monitors. (Getty Images)

FDA warns patients about Bluetooth flaws affecting pacemakers, glucose monitors

It is the latest in a series of FDA advisories to inform patients of potential cybersecurity and safety risks.

Mar 5, 2020 By Sean Lyngaas

FDA urges patients to ditch vulnerable insulin pumps built by Medtronic

Medtronic equipment again is the subject of a cybersecurity warning from U.S. regulators.

Jun 27, 2019 By Sean Lyngaas

heart, health care, ekg, defibrillator, pacemaker — (Getty Images)

Security flaw in Medtronic heart defibrillators is serious, DHS says, but don’t panic

The issue involves Conexus, Medtronic’s radio-frequency protocol that’s used for communication between medical technology such as defibrillators, home monitoring devices and other clinician programming tools.

Mar 22, 2019 By Jeff Stone

FDA warns users of cyber vulnerability in pacemaker programmers

The FDA has issued a cybersecurity advisory for two models of programmers used on cardiac devices like pacemakers and defibrillators.

Oct 12, 2018 By Sean Lyngaas