Devices & Diagnostics Letter

FDA officials confirmed last week that the agency is drafting guidance to address medical device security, particularly as it relates to software security patches.

AdvaMed has lashed out at the FDA’s proposed direct-to-consumer (DTC) advertising guidances, suggesting that the recommendations go beyond the agency’s regulatory authority by restricting the placement and content of help-seeking and disease awareness communications.

Twice as many people survived sudden cardiac arrest (SCA) in public spaces when they were assisted by lay responders trained in using automatic external defibrillators (AEDs) and CPR than those assisted by responders trained in CPR alone, according to a study published in the Aug. 12 New England Journal of Medicine.

Nucleic acid-amplification testing (NAT) is playing an increasingly important role in the screening of blood products in the U.S., according to results from a study published in the Aug. 19 issue of the New England Journal of Medicine.

More than 20 lots of tracheostomy tubes were recalled by Tyco’s Nellcor subsidiary last week following reports of two patient deaths associated with a cannula separation problem.

As part of its effort to improve Medicare beneficiary access to new technologies, the Centers for Medicare & Medicaid Services (CMS) launched its Council on Technology and Innovation Aug. 13.

The FDA’s Circulatory Systems Devices panel will meet Sept. 21 to discuss CPR-enhancing devices and therapies for cardiac arrest patients.

The FDA has taken action against a Louisiana diabetes firm for failing to satisfy medical device reporting (MDR) requirements for insulin pumps it imports from Korea.