New Products In Brief
This article was originally published in The Gray Sheet
Executive Summary
St. Jude launches new ICDs and CRTs with coating to resist lead failures. Meridian earns a 510(k) for a new pneumonia molecular diagnostic. More new product news
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News In Brief
Industry urges restraint at 510(k) modifications meeting. User fee sequestration unaddressed at House Appropriations Committee markup. More news
St. Jude Tries To Get Ahead Of Questions On Durata ICD Leads
The company hopes an independent analysis of its Optim-insulated Durata leads will address questions from the clinical community based on concerns with its earlier-generation Riata devices.
Abbott's ‘Bedrock Of Good Health’ Nutritionals Business Faces Mounting Infant Formula Litigation
Nutritional product business had 5.1% Q1 sales growth and is like Abbott’s other segments, “super well-aligned to the global demographics and trends in health care,” says CEO Ford. But as it defends complaints of damages from powder formulas made at facility found with unsafe levels of bacterial contaminants, Abbott’s also targeted in litigation alleging failure to warn about risk of infants born prematurely developing necrotizing enterocolitis if fed cow’s milk-based formula.