FDA Raises Concerns About The Cybersecurity Of Medical Devices Reply

The FDA has raised concerns about the vulnerability of medical devices to cyberattack. In one dramatic instance, reported by the Wall Street Journal, a VA catheterization laboratory in New Jersey was temporarily closed after malware infected the lab’s computer devices.


Halamka offered some additional perspective on the problem to the Washington Post:

“There’s almost no medical device that doesn’t have a network jack on the back. To fight the evils of the Internet, not only do you have to have a moat, you have to have a drawbridge, burning oil to pour on attackers, and guys with arrows.”

Click here to read the full story on Forbes.


FDA Proposes Higher Regulatory Scrutiny For Automatic External Defibrillators Reply

Automated external defibrillators (AEDs) will have a more difficult time getting on the market if a new FDA proposal is finalized. The agency today proposed a new rule that will require AED manufacturers to submit pre-market approval (PMA) applications.

“Automated external defibrillators save lives,” said cardiologist William Maisel, deputy director of science and chief scientist at the FDA’s Center for Devices and Radiological Health, in an FDA press release. “However, the agency is concerned about the number of recalls and manufacturing problems that have been associated with these devices and we’re committed to working with manufacturers to address these issues.”

Click here to read the full story on Forbes.


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What’s Next for the iPhone ECG Following Regulatory Clearance? 2

from Medical Device and Diagnostic Industry:

What’s Next for the iPhone ECG Following Regulatory Clearance?

 The user base and functionality of mobile ECG technology is set to expand.

“After recently winning FDA clearance and CE Mark certification, the iPhone ECG from AliveCor (San Francisco, CA), is poised to kickstart a disruption of the traditional ECG market.”


“In November 2011, Topol used the device to diagnose a myocardial infarction while on a plane en route from Virginia to San Diego. The plane made an emergency landing and the patient survived the ordeal.”

Click here for the entire article from Medical Device and Diagnostic Industry.