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Latest From Elizabeth Orr
A device manufacturer wouldn’t violate anti-kickback law by offering hospitals a refund if their joint replacement fails for patients, the Department of Health & Human Services’ Office of the Inspector General said in a recent advisory opinion.
US FDA has issued a final guidance document discussing appropriate labeling for products containing heparin. The new rules reflect recent revisions to US Pharmacopeia monographs on heparin solutions.
An Ohio federal judge recently awarded $645m to Acelity subsidiary KCI Inc. The company sued Healthcare Essentials Inc. for allegedly stealing wound-therapy units for resale.
US FDA has taken the rare step of publicly disputing a study that seemed to show elevated risks of long-term adverse events associated with silicone breast implants.
A group of patient advocates including one former US FDA official met with agency staff on Sept. 13 to raise awareness about adverse events tied to LASIK surgery. The group said the vision-correcting procedure is too risky to be offered as elective surgery.
Device manufacturers have long been aware of federal laws governing consumer data protection. But a new focus on state laws, as well as strict standards recently passed in California, may offer a new risk, experts say.