Medtronic (Minneapolis) has hit a huge bump in the road in its bid to get its Amplify rhBMP-2 matrix onto the U.S. market. The med-tech giant's plans for the bone graft to be approved were stalled when the FDA sent it a letter saying that it wouldn't be able to approve the application without additional information from the firm. (Medical Device Daily)
Large med-tech companies will have to continue to look toward M&A activities to supplement slower organic growth in mature markets, according to The Walden Group's (Tarrytown, New York), 2010 report. The 30-page document, which includes acquisitions in the medical device sector, highlights seven key deals or those transactions with a value of more than $100 million. (Medical Device Daily)
A test developed by BG Medicine (Waltham, Massachusetts) could give physicians far greater insight on how to assess patients diagnosed with chronic heart failure. The company's test, Galectin-3 has approval in the U.S. and is said by the firm to be the first cardiac test cleared by the FDA in five years. (Medical Device Daily)
With a healthy dose of media exposure under its belt, IntraPace's (Mountain View, California) abiliti weight loss device is making significant strides in Europe. A few short months after the company reported that it had received CE mark for abiliti (Medical Device Daily, Jan. 13, 2011), the company is starting to flesh out its plans to eventually bring the device to the U.S. (Medical Device Daily)
CyberKnife developer, Accuray (Sunnyvale, California) looks to more than double its size with the acquisition of TomoTherapy (Madison, Wisconsin). Accuray would acquire TomoTherapy for about $277 million or $4.80 per share in cash and stock. (Medical Device Daily)
A merger agreement between Daiichi Sakyo (Tokyo) and Plexxikon (Berkeley, California) just shy of $1 billion could lead to better personalized treatments for melanoma patients. (Medical Device Daily)