HeartWare International Inc.
HeartWare lands FDA OK for extended trial ahead of PMA review | Regulatory Roundup
Cameron Health’s FDA date is good news for Boston Scientific
Cameron Health landed an April date with the FDA’s circulatory devices panel to review a pre-market approval application for its lead-free subcutaneous implantable cardioverter defibrillator, or S-ICD.
The S-ICD system, unlike traditional ICDs, sits just beneath the skin and does not rely on wires relayed through blood vessels and connected to the heart in order to provide heart rhythm therapy.
Ex-Medtronic CEO Hawkins to chair new med-tech research center | Personnel Moves
Former Medtronic (NYSE:MDT) CEO Bill Hawkins will serve as the first chairman of a new private-public partnership aimed at improving development and testing of medical devices.
The partnership includes the Minnesota med-tech community, the FDA’s Center for Devices & Radiological Health and the University of Minnesota to establish a regulatory science center in the North Star State.
MassDevice.com +7 | The top 7 med-tech stories for the week of February 13, 2012.
Say hello to MassDevice +7, a bite-sized view of the top seven med-tech stories of the week. This latest feature of MassDevice.com’s coverage highlights our seven biggest and most influential stories from the week’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
If you read nothing else this weekend, make sure you’re still in the know with MassDevice +7.
Olympus execs arrested | Wall Street Beat
Prosecutors in Tokyo yesterday carried out the first arrests in connection with an accounting scandal that’s shaved 50% from the value of Olympus Corp. (TYO:7733) since last October.
HeartWare gains on Wall Street as losses widen in 2011 | Earnings Roundup
HeartWare International (NSDQ:HTWR) reported strong sales growth amid widening losses for the 4th quarter and 2011, and Wall Street showed some love.
The Framingham, Mass.-based heart pump maker raked in $82.8 million for the year ended Dec. 31, 2011, a 50% bump from $55.2 million in 2010. Losses, however, widened to $55.1 million, or $3.94 per diluted share. Analysts had forecast a loss of $3.17 per diluted share for 2011.
HeartWare gains on Wall Street as losses widen in 2011
HeartWare International (NSDQ:HTWR) reported strong sales growth amid widening losses for the 4th quarter and 2011, and Wall Street showed some love.
The Framingham, Mass.-based heart pump maker raked in $82.8 million for the year ended Dec. 31, 2011, a 50% bump from $55.2 million in 2010. Losses, however, widened to $55.1 million, or $3.94 per diluted share. Analysts had forecast a loss of $3.17 per diluted share for 2011.
Edwards lands CE Mark for Intuity valve | Regulatory Roundup
Edwards Lifesciences Corp. (NYSE:EW) landed CE Mark approval in the European Union for its Intuity valve system.
The Intuity valve, made of bovine pericardial tissue, is a minimally invasive option for patients in need of aortic valve replacement.
HeartWare gains after landing a date with the FDA
HeartWare International (NSDQ:HTWR) shares closed up 2.4% today after the company won a hearing date before the FDA’s circulatory system devices panel in April.
The sympathetic vibrations generated by the news also drove up shares of heart-pump rival Thoratec and Edwards Lifesciences , which is awaiting news of its own review by the panel for one of the PMA applications for its Sapien replacement heart valve.
Venture capital outlook a mixed bag | Wall Street Beat
The volatility of the stock markets last year was mirrored in the venture capital arena, according to Mark Heesen, president of the National Venture Capital Assn.
"Be prepared for a roller coaster ride here, because that’s where we’ve been for the past year – and that’s where we’re going," Heesen told Xconomy.