Cybersecurity
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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 Nick Paul Taylor • Sept. 27, 2023 -
Courtesy of U.S. Food and Drug Administration
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 Nick Paul Taylor • Sept. 7, 2023 -
Permission granted by Becton Dickinson
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 Elise Reuter • July 13, 2023 -
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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 Susan Kelly • July 5, 2023 -
Permission granted by Taylor Wessing
OpinionThe 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 -
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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 Nick Paul Taylor • Updated June 12, 2023 -
Carol Highsmith. (2005). "The Apex Building" [Photo]. Retrieved from Wikimedia Commons.
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 -
Andrii Yalanskyi via Getty Images
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 Nick Paul Taylor • April 21, 2023 -
Marco_Piunti via Getty Images
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 Elise Reuter • Updated March 30, 2023 -
Permission granted by MedCrypt
Q&AFriday 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 Elise Reuter • March 3, 2023 -
Courtesy of Flex
OpinionWhy 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 -
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Medtech trends in 2023Medtech 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 -
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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 Susan Kelly • Jan. 25, 2023 -
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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 Nick Paul Taylor • Dec. 8, 2022 -
Permission granted by Becton Dickinson
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 Nick Paul Taylor • Updated Dec. 6, 2022 -
Johnny Greig via Getty Images
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 -
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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 Susan Kelly • Nov. 14, 2022 -
Sarah Silbiger via Getty Images
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 Nick Paul Taylor • 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 Nick Paul Taylor • Oct. 13, 2022 -
Courtesy of Becton, Dickinson and Company
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 Nick Paul Taylor • Oct. 6, 2022 -
Sean Gallup/Getty Images via Getty Images
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 -
Sarah Silbiger via Getty Images
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 Nick Paul Taylor • Sept. 27, 2022 -
Courtesy of https://news.medtronic.com/MiniMed-R-670G-Hybrid-Closed-Loop-System#assets_34137_21-122
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 Nick Paul Taylor • Sept. 21, 2022 -
Mark Wilson/Getty Images via Getty Images
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 -
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
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 Nick Paul Taylor • Updated Sept. 8, 2022
