Cybersecurity
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Permission granted by CMR Surgical
Robots, AI and PFA: The top medtech Q&As of 2024
From challenging market leaders to the growing influence of artificial intelligence, medical device executives had a lot to discuss this year. Check out MedTech Dive’s top Q&As of 2024.
By Ricky Zipp • Dec. 20, 2024 -
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BD receives FDA warning letter over quality system violations
Inspectors found 111 open tickets for software defects categorized as catastrophic or severe patient harm. Several safety complaints were also listed that BD didn’t report within the required timeframe.
By Nick Paul Taylor • Dec. 20, 2024 -
Sarah Silbiger via Getty Images
Q&ACDRH cyber official on compliance with new rules, ongoing security threats
Nastassia Tamari discussed compliance with new device cybersecurity requirements, the risks of legacy devices and frequent cyberattacks in healthcare.
By Ricky Zipp • Updated Dec. 17, 2024 -
JuSun via Getty Images
Artivion says cybersecurity incident has disrupted order, shipping processes
The heart device manufacturer has taken certain systems offline in response to the incident, which involved the acquisition and encryption of files.
By Nick Paul Taylor • Dec. 11, 2024 -
Just_Super via Getty Images
AI-enabled apps top ECRI’s list of health tech hazards in 2025
Other health tech hazards on ECRI’s annual list include the unmet technology support needs of home care patients, cybersecurity threats and substandard or fraudulent medical devices.
By Nick Paul Taylor • Dec. 9, 2024 -
Sarah Silbiger via Getty Images
FDA prioritizes guidance on lab developed tests in 2025 plan
The Center for Devices and Radiological Health intends to develop final guidance on its enforcement discretion policy regarding special controls for LDTs, among other topics.
By Nick Paul Taylor • Oct. 18, 2024 -
Elise Reuter/MedTech Dive
The Medtech ConferenceLegacy medical devices keep regulators up at night
The FDA’s Suzanne Schwartz said at The Medtech Conference that addressing legacy devices is a “work in progress” and a problem regulators and industry need to work on together.
By Elise Reuter • Oct. 17, 2024 -
Scott Olson/Getty Images via Getty Images
Deep Dive4 steps to minimize the threat of legacy medical devices
Older medical devices with unsupported software pose cybersecurity threats that regulators and industry are struggling to solve. Here are four steps experts say can help mitigate risks.
By Ricky Zipp • Sept. 23, 2024 -
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Henry Schein’s slow recovery from cyber incident hits Q2 results
William Blair analysts said the “lingering impacts from the cyberattack are somewhat surprising.”
By Nick Paul Taylor • Aug. 7, 2024 -
Sarah Silbiger via Getty Images
FDA officials outline benefits of AI lifecycle management
The digital health leaders detailed a seven-stage diagram for how the healthcare industry could monitor artificial intelligence software development.
By Nick Paul Taylor • July 30, 2024 -
Matt Kapko/MedTech Dive
CrowdStrike outage hits US hospitals
The cybersecurity firm released what was meant to be a routine software update, but now health systems, including CommonSpirit Health and Cleveland Clinic, are locked out of Windows systems.
By Susanna Vogel • July 19, 2024 -
Sascha Schuermann via Getty Images
CISA warns of cybersecurity risks in Baxter products
The cybersecurity notices covered vulnerabilities identified in a Baxter Welch Allyn patient monitor and a Baxter Welch Allyn configuration tool.
By Ricky Zipp • Updated June 10, 2024 -
JuSun via Getty Images
More than a third of healthcare organizations aren’t prepared for cyberattacks: report
Thirty-seven percent of healthcare organizations did not have a cyberattack contingency plan in place, despite half having experienced an attack, according to a new survey from Software Advice.
By Sydney Halleman • May 28, 2024 -
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GE Healthcare warns of cybersecurity risks in ultrasound devices, software
Cybersecurity group Nozomi Networks Labs identified 11 vulnerabilities across several systems and software in an investigation of imaging machines.
By Nick Paul Taylor • May 15, 2024 -
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Livanova says patient data obtained in 2023 cyberattack
Livanova learned that an unauthorized party obtained patient data, including Social Security numbers and health conditions, during last year’s attack.
By Ricky Zipp • April 26, 2024 -
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Files taken from Orasure systems in cybersecurity incident
Orasure believes it has contained the incident and “preserved the integrity of its core financial and operational systems.”
By Nick Paul Taylor • April 17, 2024 -
Techa Tungateja via Getty Images
Deep DiveAs cyberattacks on healthcare persist, can the FDA’s new device regs hold up?
Revamped regulations to thwart hackers are a big step forward, but issues such as legacy devices and reliance on software patches pose lingering challenges.
By Ricky Zipp • April 3, 2024 -
Just_Super via Getty Images
FDA seeks feedback on expansion of premarket cybersecurity guidance
The agency is providing information on cybersecurity requirements for companies seeking authorization of new devices.
By Nick Paul Taylor • March 13, 2024 -
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AI to expand medtech portfolios, revenue streams: Moody’s
The rating agency predicts AI will start to have a positive impact on medical device companies in the next two years.
By Nick Paul Taylor • March 12, 2024 -
Bruce Bennett via Getty Images
Henry Schein expects cyber incident costs to continue in 2024
The company reported a $350 million to $400 million reduction in Q4 sales due to the incident, which forced it to take some systems offline.
By Elise Reuter • Feb. 27, 2024 -
Sara Silbiger via Getty Images
FDA creates ‘super office’ to oversee device cybersecurity, digital health and supply chain
The reorganization establishes new divisions at the Office of Strategic Partnerships and Technology Innovation to account for its growth since 2019.
By Nick Paul Taylor • Jan. 25, 2024 -
JuSun via Getty Images
Patient records exposed in data breaches doubled in 2023
Though the number of data breaches declined slightly from 2022, more than 116 million records were exposed last year, according to a new report from a cybersecurity firm.
By Emily Olsen • Jan. 22, 2024 -
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Roundup: Cyber incidents, vulnerabilities hit the medtech sector in 2023
From vulnerable medical devices to a breach that took some of Henry Schein’s systems offline, cybersecurity was a key topic for the industry this year.
By Ricky Zipp • Dec. 21, 2023 -
Courtesy of Billington CyberSecurity Summit
White House wants to set minimum cyber standards for hospitals, healthcare
The sector has faced a wave of ransomware linked to the critical CitrixBleed vulnerability, which has led to major attacks from LockBit and other threat groups.
By David Jones • Dec. 12, 2023 -
Bruce Bennett via Getty Images
Henry Schein says 29K people affected in September cyber incident
The ransomware group AlphV/BlackCat has claimed responsibility for the data breach and a second incident involving the company.
By Susan Kelly • Dec. 8, 2023
