Tag Archives: Edwards Lifesciences

Double trouble: Two firms under FDA’s microscope

A lot of warning letters and other FDA enforcement action are addressed to obscure companies, but lately a few big names have come under scrutiny. In a recent posting here at MDD Perspectives, we addressed a warning letter to Edwards…

FacebookTwitterGoogle+Share

Being there first: Personalized medicine and the investor

I don’t directly invest in med-tech, but attending Transcatheter Cardiovascular Therapeutics for five years makes me wonder how an investor separates winners and losers. I know TCT 2011 has both, but which are which? Asking about the patient population is…

FacebookTwitterGoogle+Share

The Good, the Bad and the Ugly: Third-party coverage requests

As a member of the trade press, I get a kick out of how routinely some people in the mainstream media and the population at large routinely assume that device makers are driven by greed and that doctors are morally…

FacebookTwitterGoogle+Share

Picking your poison: Wall Street or Venture Capital?

Life is full of choices, not all of them pleasant. For device makers of late, this definitely holds true. Firms in the venture capital end of things are not necessarily worried that VC has utterly abandoned med-tech, but it would…

FacebookTwitterGoogle+Share

Medtronic’s $2.5M InFuse fix: Off-label use + implant = headaches

The deal struck by Medtronic (Fridley, Minnesota) regarding an evaluation of adverse events associated with off-label use of the InFuse bone morphogenic protein is conspicuous, but not so much because it will cost the firm $2.5 million to have Yale…

FacebookTwitterGoogle+Share

FDA to small firms: Thanks but no thanks

There’s nothing like having siblings who are several years older and in their teens. You admire them for being so mature and so big. When you wanted to hang out with them, though, maybe they told you to buzz off….

FacebookTwitterGoogle+Share

TAVR looked upon as next med-tech blockbuster, but is it ready for primetime?

It’s easy to understand the excitement about the PARTNER trial, sponsored by Edwards Lifesciences (Irvine, California), the company that makes the much talked about transcatheter aortic valve replacement (TAVR) device, called the Sapien. After all, given the choice between open…

FacebookTwitterGoogle+Share

Marketo