As expected, HeartWare (Framingham, Massachusetts) says it has submitted a pre-market approval (PMA) application to the FDA for the HeartWare ventricular assist system as a bridge to heart transplantation for patients with end-stage heart failure. The PMA filing had been expected by the end of the year (Medical Device Daily, Dec. 23, 2010). (Medical Device Daily)

A new white paper from Fuld (Cambridge, Massachusetts), a research and consulting firm in the field of business and competitive intelligence, suggests that generic medical devices are “closer than they appear.“ (Medical Device Daily)

HeartWare (Framingham, Massachusetts) is in an even better position to begin a robust build-out of its U.S. sales and support infrastructure after having recently completed a $125 million convertible note transaction, according to Canaccord Genuity (Toronto) analyst Jason Mills. (Medical Device Daily)

Medtronic (Minneapolis) has received FDA approval to sell its Endurant AAA stent graft system in the U.S. for the minimally invasive treatment of AAA, a largely unknown and often fatal condition. (Medical Device Daily)

Inevitability is the word that comes to mind this week, particularly for those who follow the ophthalmology industry, as Novartis (Basel, Switzerland) and Alcon (Huenenberg, Switzerland) have finally agreed on a price for the remaining 23% of Alcon shares that Novartis did not already own. (Medical Device Daily)

It doesn't happen every day but once in a while a medical device is developed that ends up having benefits above and beyond what its maker originally intended it for. That seems to be the story for CorMatrix Cardiovascular (Marietta, Georgia), a company that develops extracellular matrix (ECM) biomaterial devices designed to harness the body's innate ability to repair damaged cardiovascular tissue. (Medical Device Daily)

Getting FDA 510(k) is a victory under any context but, given how close the regulatory agency is to releasing its recommendations for tightening up the program, winning FDA clearance for the Optical Coherence Tomography Imaging System (OCTIS) was a particularly significant achievement for Tomophase (Burlington, Massachusetts) last week. (Medical Device Daily)