Product Labeling

In part one of a three-part Healio exclusive series, experts discussed the need for clinical guidance and evidence for the use of AI to improve cardiovascular outcomes.

Editor’s Note: This is part two of a three-part Healio Exclusive series on the development and use of AI to improve clinical outcomes in cardiovascular medicine and considerations for regulatory labeling and patient privacy.

LAS VEGAS — Fifty-two percent of American consumers surveyed said a “Made in the USA” label is an important factor in their purchasing decisions, according to a report from the Vision Council.

CVRx Inc. announced the FDA approved its revised instructions for use for its baroreflex activation therapy device incorporating clinical data from the BeAT-HF randomized clinical trial.

The FDA has issued a warning against the purchase or use of products that contain tianeptine, which has been illegally sold with claims to improve brain function and treat anxiety, depression, pain, opioid use disorder and other conditions.

The National Rosacea Society is launching a Seal of Acceptance program that will assist individuals suffering from rosacea in finding rosacea-friendly products, the society announced in a press release.

The FDA has released draft guidance to recommend — but not require — food manufacturers to declare sesame on products’ ingredients lists.

The FDA today issued a series of recommendations following an advisory panel meeting on a signal of late mortality risk associated with paclitaxel-coated devices to treat peripheral artery disease, including advising clinicians to discuss extensively with patients the risks and benefits of the devices and to ensure patients are on optimal medical therapy and are following appropriate lifestyle practices.