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