GE medical imaging devices impacted by critical cyber vulnerability

Dozens of products like CT scanners and MRI machines are susceptible to hackers getting access to sensitive health data and disrupting their operation, according to firm CyberMDX. GE says there is no risk to patient safety.

By Greg Slabodkin • Dec. 8, 2020

BD's Alaris infusion pumps flagged for cybersecurity vulnerability

The Department of Homeland Security alert scored the issue 6.5 out of 10 and said a successful attack that exploited the weakness could force operators to manually program the pumps.

By Nick Paul Taylor • Nov. 13, 2020

Explore the Trendline➔

Top 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

FDA floats framework to message cybersecurity threats to patients

The proposal, which has the agency and industry sharing responsibility for making the information easy to find, comes as the risks to medical devices continue to grow.

By Nick Paul Taylor • Oct. 21, 2020

FDA launches years-in-the-making digital health center

The center's focus areas will include the Pre-Cert program, AI and machine learning in software as a medical device, as well as cybersecurity and wireless medical devices.

By Susan Kelly • Sept. 23, 2020

Insulin pumps among millions of devices facing risk from newly disclosed cyber vulnerability, IBM says

The firm's hacking team said the vulnerability may allow criminals to remotely alter patient dosing, as well as manipulate readings from medical device monitors "to cover up concerning vital signs or create false panic."

By Greg Slabodkin • Aug. 25, 2020

'If the public knew:' Ripple20 shows medical device software cyber weakness

Last month’s discovery that Baxter and B. Braun infusion pumps face risk of remote attacks by hackers comes as a medtech effort gains momentum to track third-party components in devices.

By Greg Slabodkin • July 7, 2020

Baxter, B. Braun infusion pumps among millions of devices implicated in Ripple20 cyber alert

Despite warnings that a remote hacker could gain control of a pump, medtechs affected by the vulnerabilities described it as low risk and manageable.

By Greg Slabodkin • June 24, 2020

Lack of data encryption for Baxter devices flagged in flurry of DHS alerts

The Department of Homeland Security's cyber agency published four advisories, ranging from 7.5 to 8.6 on its 10-point severity scale, about vulnerabilities in infusion pumps, hemodialysis delivery systems and other tech.

By Nick Paul Taylor • June 19, 2020

Coronavirus chaos ripe for hackers to exploit medical device vulnerabilities

Interpol warned that cybercriminals are using ransomware to target healthcare organizations already overwhelmed by COVID-19, and noted a significant increase in detected health system attacks since the start of the pandemic.

By Greg Slabodkin • April 8, 2020

Vulnerability in medication dispensing system flagged again by DHS cyber team

An alert Tuesday from the Department of Homeland Security is the third issued in relation to BD's Pyxis products in as many years.

By Nick Paul Taylor • April 1, 2020

Some pacemakers, EKGs, diabetes devices may face newly flagged Bluetooth cyber risk

FDA and the Department of Homeland Security said microchips from seven manufacturers and a range of consumer wearables and connected medical devices may be affected.

By Susan Kelly • March 4, 2020

California's new cybersecurity law sidesteps most medical devices, lawyers say

How the state enforces its "internet of things" or connected devices law "may end up becoming a source of persuasive authority for the FDA in its decision making" on cybersecurity guidance, said White and Williams' Joshua Mooney.

By Fred Donovan • Feb. 28, 2020

DHS warns of WannaCry-like vulnerability in Spacelabs Healthcare systems

The homeland security agency revealed certain telemetry devices suffer from the weakness, scoring 9.8 out of 10 on a cybersecurity vulnerability scale.  

By Nick Paul Taylor • Feb. 19, 2020

Hospitals, clinics most likely to be hit with ransomware attack

But medical testing and supplies companies weren't spared among the 172 individual attacks from 2016 to 2019 that affected 6.6 million patients. 

By Shannon Muchmore • Feb. 11, 2020

GE cybersecurity flaw gets maximum risk score, triggering rare FDA notice

"An attacker could potentially silence an alarm that is intended to communicate vital information about a patient to health care staff, such as a patient's cardiac status," the agency wrote of an issue with certain tech platforms.

By Nick Paul Taylor • Jan. 24, 2020

EU group offers guidance on meeting MDR's cybersecurity standards

The document says it's important to reference the International Medical Device Regulators Forum's cybersecurity guidance, and policies like the General Data Protection Regulation and the EU Cybersecurity Act "might apply in parallel."

By Susan Kelly • Jan. 7, 2020

Roundup 2019: Breast implants, mesh, paclitaxel-coated devices among hot topics at FDA expert panels

The public meetings in some cases instigated voluntary recalls and led to required market removals. Nearly all called for further research or more robust medical device monitoring.

By Maria Rachal • Dec. 23, 2019

Dexcom server outage rocks Type 1 diabetes community

The company announced late Monday it has restored services for its Dexcom Follow app to "near normal performance." Dexcom said it will work to improve communication methods with its customers.

By David Lim • Updated Dec. 3, 2019

Medtronic reveals high-risk cyber vulnerability in electrosurgical generators

The Department of Homeland Security rated the vulnerability, which could be exploited remotely by a low-skilled hacker, a 9.8 on a 10-point risk scale.

By Nick Paul Taylor • Nov. 8, 2019

FDA expands MDIC quality pilot to non-compliant manufacturers

A $2.8 million funding award from the agency aims to extend a program used by big players like Medtronic, Abbott and Boston Scientific to those not yet up to snuff on regulatory compliance.

By Susan Kelly • Oct. 22, 2019

Hospitals, manufacturers could donate cybersecurity software under proposed regs

With the cost of protecting systems from malicious hackers increasing, the idea to tweak the anti-kickback laws recognizes some physician practices don't have the resources or expertise to keep pace, one lawyer told MedTech Dive.

By David Lim • Oct. 14, 2019

Amazon Textract now HIPAA-eligible as tech giant expands AI portfolio

Of Amazon's $3.1 billion in operating income last quarter, more than half came from its cloud services business. 

By Rebecca Pifer • Oct. 11, 2019

From robots to staplers, a top 10 list of medtech safety hazards

The nonprofit ECRI identified increased use of certain devices outside of acute care settings and adoption of some technologies before safety is fully assessed as common themes in its annual ranking.

By Susan Kelly • Oct. 8, 2019

Third-party software vulnerability could endanger medical devices, FDA and DHS warn

The alerts expand the list of vendors whose operating systems could be exploited due to vulnerabilities known as URGENT/11. Medical devices affected include an infusion pump and an anesthesia machine, FDA said Tuesday.

By Susan Kelly • Oct. 2, 2019

FDA creates agencywide tech modernization roadmap

The agency plans to spend the next one to two years upgrading its infrastructure to meet emerging data handling needs.

By Nick Paul Taylor • Sept. 19, 2019