Seeking Alpha
SA's VP content, editor in chief
Profile| Send Message|
( followers)

Heart device maker Edwards Lifesciences Corp. said yesterday it received a warning from the FDA about the quality-systems handling at its California facility. The warnings states that Edwards will cease to received FDA premarket approval for devices "reasonably related to those issues." CEO Edwards Lifesciences Corp 21 02 2007 ChartMichael A. Mussallem said the company is fully committed to resolving the issues promptly, and does not expect the matter to have a material impact on its 2007 financial guidance. Products on its horizon that require FDA approval include a new use for its "LifeStent" and a next-gen replacement valve for the heart's mitral position. EW stock was down $1.43 (2.7%) to $50.98 in yesterday's trading.

Sources: Press Release, Wall Street Journal
Commentary: Biotech Day in Review: 20/2/2007
Stocks/ETFs to watch: Edwards Lifesciences Corp. (NYSE:EW)

Seeking Alpha's news summaries are combined into a pre-market briefing called Wall Street Breakfast. Get Wall Street Breakfast by email -- it's free and takes only a few seconds to sign up.

Source: Edwards Lifesciences Receives FDA Warning