A new FDA approval is expected to be an important catalyst for Integra Lifesciences Corp. (Plainsboro, N.J.) and represents a step in the right direction for the broader diabetic foot ulcer (DFU) market.
Fueled by a recent $42 million financing, Ivenix Inc. (Amesbury, Mass.) has a new CEO in its driver's seat ready to steer the company toward commercialization of its infusion pump management system. The company said it has made "substantial progress" in product development since it raised the funds in September, led by new investor Wuxi Healthcare Ventures, and is now preparing for regulatory filings to enter the $6 billion global infusion market. Stuart Randle, the new CEO of Ivenix, was previously president and CEO of GI Dynamics Inc. (Lexington, Mass.).
In a market as competitive as obesity, a society position statement touting a particular product isn't a bad form of recognition. The American Society for Metabolic and Bariatric Surgery (ASMBS; Gainesville, Fla.) published a statement in its journal, Surgery for Obesity and Related Diseases, supporting vagal blocking therapy for obesity, based on a review of clinical results of the Vblock neurometabolic therapy device from Enteromedics Inc. (St. Paul, Minn.).
Known for its implantable ventricular assist device, Heartware International Inc. (Framingham, Mass.) (NASDAQ: HTWR) defended its pending acquisition of Valtech Cardio Ltd. (Yehuda, Israel) in response to a notice from Engaged Capital LLC nominating three directors for Heartware's board. The threat comes six months ahead of the company's annual meeting, usually held in June.
At the very least, 2015 could be described as interesting for the medical device industry, with a number of companies successful initial public offerings and non-traditional players like Google Inc. (Mountain View, Calif.) and Samsung Electronics Co. Ltd. (Suwon, South Korea) stepping up in the life sciences game. But of all the impactful stories reported this year, the one that zipped to the top of Medical Device Daily's annual list was the recently reported medical device tax suspension (Medical Device Daily, Dec. 21, 2015).
