Cybersecurity


  • Fingers hover over a computer keyboard with numbers on a screen, against a shadowy backdrop.
    Image attribution tooltip
    jariyawat thinsandee via Getty Images
    Image attribution tooltip

    FDA finalizes guidance on cybersecurity for medical devices

    Congress granted the agency authority to deny premarket submissions that lack cybersecurity information, starting in October. 

    By Sept. 27, 2023
  • Exterior of FDA headquarters
    Image attribution tooltip
    Courtesy of U.S. Food and Drug Administration
    Image attribution tooltip

    FDA proposes 3 guidances to improve 510(k) clearance process

    The agency has made recommendations for selecting predicate devices, using clinical data and conducting performance testing for implants.

    By Sept. 7, 2023
  • Becton Dickinson logo
    Image attribution tooltip
    Permission granted by Becton Dickinson
    Image attribution tooltip

    Becton Dickinson flags cybersecurity vulnerabilities in Alaris system

    The company identified eight security issues affecting its infusion pump system, including one high-risk concern.

    By July 13, 2023
  • A depiction of computer hardware.
    Image attribution tooltip
    solarseven via Getty Images
    Image attribution tooltip

    Medtronic identifies cybersecurity vulnerability in cardiac data system

    Cyber attackers could exploit the vulnerability if healthcare organizations have enabled its optional messaging service, the device maker said.

    By July 5, 2023
  • A headshot of ALison Dennis, an attorney with Taylor Wessing
    Image attribution tooltip
    Permission granted by Taylor Wessing
    Image attribution tooltip
    Opinion

    The importance of trust in AI as a medical device

    Building trust with patients, as well as regulators, will be key to the adoption of AI in medical devices and diagnostics, argues Alison Dennis, a London-based partner with law firm Taylor Wessing.

    By Alison Dennis • June 15, 2023
  • the Eu flag over a map of europe
    Image attribution tooltip
    titoOnz via Getty Images
    Image attribution tooltip

    MedTech Europe sets out position on cybersecurity, making case for reliance on MDR

    As the number of connected medical devices grows, the industry group argues that Europe’s new medtech regulations should remain “the primary avenue” for medical device cybersecurity.

    By Updated June 12, 2023
  • Federal Trade Commission
    Image attribution tooltip
    Carol Highsmith. (2005). "The Apex Building" [Photo]. Retrieved from Wikimedia Commons.
    Image attribution tooltip

    FTC moves to strengthen Health Breach Notification Rule’s applicability to digital health apps

    Regulators are increasingly leaning on the HBNR to crack down on the sharing of sensitive medical data, and the FTC is looking to strengthen its case.

    By Rebecca Pifer • May 18, 2023
  • A series of hexagonal blocks with locks on them, one of which is broken, with a red background.
    Image attribution tooltip
    Andrii Yalanskyi via Getty Images
    Image attribution tooltip

    Report names connected medical devices with the biggest cybersecurity risks

    The findings come as medical device makers face upcoming FDA requirements for providing cybersecurity information as part of their pre-market submissions.

    By April 21, 2023
  • A pair of binoculars covered with code, indicating a cybersecurity breach
    Image attribution tooltip
    Marco_Piunti via Getty Images
    Image attribution tooltip

    FDA says it won’t issue ‘refuse to accept’ letters on cyber devices before Oct. 1

    Until October 1, the FDA will work with device makers to ensure pre-market submissions have adequate cybersecurity information.

    By Updated March 30, 2023
  • Naomi Schwartz, MedCrypt's Senior Director of Quality and Safety, stands in front of a leafy background.
    Image attribution tooltip
    Permission granted by MedCrypt
    Image attribution tooltip
    Q&A

    Friday Q&A: MedCrypt’s Naomi Schwartz on designing cybersecurity for diabetes devices

    Schwartz, who helped review the first automated insulin dosing system, talks about balancing patient access and device security.

    By March 3, 2023
  • A headshot of Jennifer Samproni
    Image attribution tooltip
    Courtesy of Flex
    Image attribution tooltip
    Opinion

    Why medical device designers need to become more agile — and how they can do it

    To stay competitive, medtech firms must center manufacturing in business optimization plans, while embracing a design-to-value approach, says Jennifer Samproni, Flex’s chief technology officer for its Health Solutions division.

    By Jennifer Samproni • Jan. 26, 2023
  • The headquarters of the Food and Drug Administration
    Image attribution tooltip
    Sarah Silbiger via Getty Images
    Image attribution tooltip
    Medtech trends in 2023

    Medtech regulation outlook in 2023: Faster approvals among priorities as AI moves to fore

    Leaders in the medtech field weigh in on the prospects and challenges for product regulation in 2023.

    By Peter Green • Updated Jan. 26, 2023
  • Programming scripts on laptop monitor, unauthorized remote hacking of server
    Image attribution tooltip
    Motortion via Getty Images
    Image attribution tooltip

    Cybersecurity ‘more critical than ever’ in era of connected care: BD

    The device maker’s annual report on the state of healthcare cybersecurity calls for better transparency and coordination across the industry.

    By Jan. 25, 2023
  • A person in scrubs sitting in a chair talks to a person laying in bed, who is raising their arm and wearing a VR headset.
    Image attribution tooltip
    doble-d via Getty Images
    Image attribution tooltip

    FDA outlines benefits and risks of emerging augmented and virtual reality medical devices

    AR/VR may increase access to healthcare and make procedures less invasive, but could potentially cause cybersickness and head and neck strain.

    By Dec. 8, 2022
  • Becton Dickinson logo
    Image attribution tooltip
    Permission granted by Becton Dickinson
    Image attribution tooltip

    Vulnerability in BD’s infusion pump flagged to US cybersecurity agency

    An attacker with physical access to the device could exploit the vulnerability to change the configuration settings or disable the pump.

    By Updated Dec. 6, 2022
  • Team of surgeons operating on patient in hospital - stock photo Four doctors in hospital operating room with patient lying on operating table. Surgical lights shining on medical team performing operat
    Image attribution tooltip
    Johnny Greig via Getty Images
    Image attribution tooltip

    The 10 biggest medtech stories of 2022

    MedTech Dive reporting this year has explored how companies maintained momentum even amid supply shortages and rising inflation rates.

    By MedTech Dive staff • Dec. 3, 2022
  • Picture of a cybersecurity lock
    Image attribution tooltip
    iStock via Getty Images
    Image attribution tooltip

    HHS cybersecurity center warns of new ransomware threat

    Venus ransomware has attacked targets worldwide, including at least one U.S. health group, since it was first identified in mid-August.

    By Nov. 14, 2022
  • A sign for the Food And Drug Administration is seen outside of the headquarters on July 20, 2020 in White Oak, Maryland.
    Image attribution tooltip
    Sarah Silbiger via Getty Images
    Image attribution tooltip

    FDA seeks feedback on plans to draft and finalize medical device guidance in 2023

    The agency’s review includes guidance on transitioning away from emergency use authorizations, while abandoning plans for guidance on software as a medical device.

    By Oct. 19, 2022
  • GE advances healthcare spinoff plan, providing close look at workings of the unit

    Localization requirements, third-party servicers, and more sophisticated data security threats are cited as risks to the healthcare unit.

    By Oct. 13, 2022
  • Image of a cervical cell testing machine, the BD Totalys™ MultiProcessor
    Image attribution tooltip
    Courtesy of Becton, Dickinson and Company
    Image attribution tooltip

    BD discloses cybersecurity vulnerability in cervical cytology processing machine

    The company is advising users to address the threat by restricting access to the instrument while it works on a software patch.

    By Oct. 6, 2022
  • Close up of hands typing on a keyboard illuminated in orange.
    Image attribution tooltip
    Sean Gallup/Getty Images via Getty Images
    Image attribution tooltip

    Cyber risks identified in Canon Medical product used to view medical images, security firm says

    Vulnerabilities in Canon Medical’s Vitrea View product could provide access to patient information and other services, according to cybersecurity firm Trustwave Spiderlab.

    By Ricky Zipp • Updated Sept. 30, 2022
  • The front entrance of the Food And Drug Administration headquarters building.
    Image attribution tooltip
    Sarah Silbiger via Getty Images
    Image attribution tooltip

    FDA makes case for ‘new regulatory paradigm’ amid hurdles in software-oversight program

    The agency seeks to tailor requirements based on the latest science, the benefits and risks posed by devices, their real-world performance and their contribution to promoting health equity.

    By Sept. 27, 2022
  • A Medtronics diabetes device
    Image attribution tooltip
    Courtesy of https://news.medtronic.com/MiniMed-R-670G-Hybrid-Closed-Loop-System#assets_34137_21-122
    Image attribution tooltip

    Medtronic issues urgent notice about MiniMed insulin pump system vulnerability

    Unauthorized users could hack into the device while it’s being set up, and cause the pump to deliver too much or too little insulin, potentially resulting in outcomes including death.

    By Sept. 21, 2022
  • FBI headquarters
    Image attribution tooltip
    Mark Wilson/Getty Images via Getty Images
    Image attribution tooltip

    FBI warns of cyber risks from legacy medical devices

    Outdated device software can put data, patient safety and hospitals’ operations at risk, the top U.S. law enforcement agency warned.

    By Ricky Zipp • Sept. 15, 2022
  • A baxter spectrum infusion pump
    Image attribution tooltip

    Website of medical device sales form: https://spwindustrial.com/baxter-sigma-spectrum-infusion-pump-s-w-ver-8-with-dual-antenna-wireless-batt/?gclid=Cj0KCQjwpeaYBhDXARIsAEzItbFttwA55ImqoesvcmNYfm6od_td4SGgOeNOqFOQohCiU_ci1yN-oHsaAqiFEALw_wcB

    Image attribution tooltip

    Cybersecurity firm finds vulnerabilities in Baxter’s Sigma infusion pumps

    The weaknesses could allow attackers to access Wi-Fi data and make the device unavailable.

    By Updated Sept. 8, 2022