Cybersecurity: Page 3
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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 -
Explore the Trendline➔
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TrendlineTop 5 stories from MedTech Dive
From haphazard layoffs at the Food and Drug Administration to the industry’s current IPO environment and tracking FDA-authorized AI devices, here is a collection of top stories from MedTech Dive.
By MedTech Dive staff -
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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 -
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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 -
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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 -
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‘Underfunded’ FDA falls short in ensuring medical devices protect against cyberattacks, experts say
Medical device manufacturers argue the agency’s current rules on cybersecurity requirements are too restrictive and should be phased in gradually.
By Elise Reuter • Aug. 11, 2022 -
Permission granted by Kevin Fu
Q&AFriday Q&A: FDA’s former medical device cybersecurity director says more investment needed in staffing
The FDA and medtech companies will need more cybersecurity staff to stay ahead of hackers, says Kevin Fu, who is now focused on building that workforce for the government, private sector and academia.
By Elise Reuter • Aug. 5, 2022 -
Permission granted by DarioHealth
Lack of payment pathway clarity hinders digital therapeutics, analysts say
The report warns of a sector beset by payment issues, “snake oil” and “middling adoption.”
By Nick Paul Taylor • July 15, 2022 -
DHS warns cybersecurity vulnerabilities in Illumina software could affect test results
Three of the flaws outlined by the Department of Homeland Security received the highest risk score. Vulnerabilities could allow attackers to remotely alter the results generated by Illumina products.
By Nick Paul Taylor • June 6, 2022 -
Photo illustration by Danielle Ternes/MedTech Dive; photograph by spainter_vfx via Getty Images
BD's Pyxis medication dispenser gets fifth DHS cybersecurity alert in 5 years
The company said there are no known public exploits that specifically target a password vulnerability and that it's working to address the problem.
By Nick Paul Taylor • June 1, 2022 -
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Employees cause more cyber breaches in healthcare than other industries, report finds
Employees were responsible for 39% of healthcare breaches last year. That's compared to 18% across all industries, according to new Verizon research.
By Rebecca Pifer • May 27, 2022 -
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House user-fees bill details clinical trial diversity, cybersecurity requirements
The legislation would let the FDA bring in $1.78 billion in fee revenue from 2023 to 2027 to fund the review of medical devices. That amount could increase to $1.9 billion if the agency meets certain performance goals.
By Elise Reuter • May 10, 2022 -
CDRH's Shuren expects center to return to normal this year despite ongoing COVID work
Jeff Shuren, the director of the FDA's Center for Devices and Radiological Health, also stressed the need for increased cybersecurity and supply chain funding and authority during an event on April 29.
By Ricky Zipp • May 2, 2022 -
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Medtech survey finds widespread cybersecurity noncompliance despite rising investment
Over 80% of respondents see device security as a competitive advantage and almost every company budgeted more money for it this year. However, 80% view the issue as a "necessary evil" imposed by regulators.
By Nick Paul Taylor • April 21, 2022 -
Image courtesy of FDA
FDA official: Draft cybersecurity guidance has 'teeth'
Not following the guidance in premarket submissions means potential delays for device makers, said Suzanne Schwartz, director of CDRH's Office of Strategic Partnerships and Technology Innovation.
By Greg Slabodkin • April 11, 2022
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