Archive for the ‘medical devices’ Category

FDA safety scandal: 50K hidden reports of heart device malfunctioning

May 21st, 2019
The Food and Drug Administration headquarters in White Oak, Md.

Enlarge / The Food and Drug Administration headquarters in White Oak, Md. (credit: Getty | Congressional Quarterly)

The Food and Drug Administration allowed the maker of a faulty implantable heart device to secretly log 50,000 malfunction incidents, according to a series of investigations by Kaiser Health News.

The device—the Sprint Fidelis, made by Medtronic—consists of a pair of wires and a defibrillator to jolt the heart into a regular rhythm. But doctors found that it was giving patients random, harmful zaps and sometimes failed during actual cardiac emergencies.

Medtronic recalled the device in 2007 but only after it was implanted in around 268,000 patients. Many of those patients have since faced the ghastly choice of learning to live with the faulty device or undergoing an invasive, risky—sometimes deadly—surgery to remove it. According to the KHN investigation, they’ve been making that choice without information from the 50,000 incident reports.

Read 5 remaining paragraphs | Comments

Posted in fda, medical devices, regulation, safety, science | Comments (0)

Medtronic’s Implantable Defibrillators Vulnerable to Life-Threatening Hacks

March 22nd, 2019
The U.S. Department of Homeland Security Thursday issued an advisory warning people of severe vulnerabilities in over a dozen heart defibrillators that could allow attackers to fully hijack them remotely, potentially putting lives of millions of patients at risk. Cardioverter Defibrillator is a small surgically implanted device (in patients' chests) that gives a patient's heart an electric

Posted in cyber security, hacking medical devices, hacking news, Healthcare Cybersecurity, Medical Device Cybersecurity, medical devices, pacemaker, Pacemaker hacking, Vulnerability | Comments (0)

High-tech toilet seat monitors your heart as you sit on the can

February 19th, 2019

If developing heart disease scares the poo out of you, this new monitor may be just the thing.

Engineers at Rochester Institute of Technology have designed a high-tech toilet seat that effortlessly flushes out data on the state of your cardiovascular system. The tricked-out porcelain throne measures your blood pressure, blood oxygen level, and the volume of blood your heart pumps per beat (stroke volume)—taking readings every time you sit down to catch up on some reading of your own. The engineers, led by David Borkholder, recently published a prototype of the seat in the open-access journal JMIR mHealth and uHealth.

According to the inventors, the seat’s daily data dump could make patients and their doctors privy to early warning signs of heart failure, potentially helping to prevent further deterioration and avoid costly hospital stays. Moreover, the seat could ease in-home monitoring for heart patients, who often strain to consistently track their tickers with other, non-toilet-based monitors.

Read 11 remaining paragraphs | Comments

Posted in BCG, blood, cardiovascular disease, ECG, Health, heart, heart failure, heart monitor, medical devices, oxygenation, science, sensors, toilet | Comments (0)

Scanners to be patched after government warns of vulnerabilities

August 9th, 2017

Siemens says that there’s no evidence its scanners have been compromised – but the patches will be ready by the end of the month

Posted in healthcare, IoT, medical devices, Security threats, Siemens, Vulnerability | Comments (0)

Independent labs to probe medical devices for security flaws

July 27th, 2017

Medical devices have been a focus of concern – but a network of independent labs will work with manufacturers and health providers to improve their security health

Posted in healthcare security, medical devices, Security threats, WHISTL Labs | Comments (0)

Independent labs to probe medical devices for security flaws

July 27th, 2017

Medical devices have been a focus of concern – but a network of independent labs will work with manufacturers and health providers to improve their security health

Posted in healthcare security, medical devices, Security threats, WHISTL Labs | Comments (0)

Your pacemaker could be put in the witness box against you

July 24th, 2017

What happens when a wearable or embedded medical device tells a different story to someone suspected of a crime?

Posted in Law & order, medical devices, Technologies | Comments (0)

Pacemakers patched against potentially lifethreatening hacks

January 12th, 2017

Potential exploits are ‘the fuel of nightmares’, say experts

Posted in DHS, fda, Law & order, medical devices, pacemakers, Security threats, St. Jude Medical, USFDA, Vulnerability | Comments (0)

Medical Devices Should Withstand Rigor, Expert Says

September 23rd, 2016

In a keynote at the Internet of Things Forum Dr. Kevin Fu said that medical devices should be subjected to rigor so patients can make clinically relevant decisions.

Posted in Archimedes Center for Medical Device Security, Dr. Kevin Fu, Health, Health Security, hospitals, Internet of things, IoT, Medical device security, medical devices, vulnerabilities | Comments (0)

Code Blue: Thousands of Bugs Found on Medical Monitoring System

July 26th, 2016

In-brief: The Department of Homeland Security warned of hundreds of vulnerabilities in a hospital monitoring system sold by Philips. Security researchers who studied the system said the security holes may number in the thousands. Security researchers analyzing a critical piece of equipment used to monitor patients in hospitals have uncovered thousands of vulnerabilities on the system, including 272 in the monitoring system itself and hundreds more in third-party components that run alongside it. The Department of Homeland Security’s Industrial Control Systems Cyber Emergency Response Team (ICS-CERT) issued an alert on July 14 about the discovery of 460 vulnerabilities in the Philips Xper-IM Connect system, including 360 with a severity rating of “high” or “critical” severity. But an interview with one of the researchers who analyzed the Xper system said that the true number of vulnerabilities was much higher, numbering in the thousands. Xper IM Connect is a “physiomonitoring” system that is widely used in the […]


Definitive Guide to DLP

Posted in biomedical devices, connected devices, DHS, ICS-CERT, Internet of things, medical devices, Network, Philips, remote code execution, Reports, software, vulnerabilities, Whitescope | Comments (0)