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…
FDA Proposes Higher Regulatory Scrutiny For Automatic External Defibrillators
March 22, 2013 by Leave a Comment
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…
What’s Next for the iPhone ECG Following Regulatory Clearance?
January 4, 2013 by 2 Comments
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…
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