By the end of the year Lensar (Orlando) will have achieved two FDA clearances, raised $24 million in private financing, installed about 30 of its laser systems in 11 countries, and have been profiled on the popular television show "The Doctors." Not too shabby for a small, independent med-tech company.
Mauna Kea Technologies (Paris), developer of the Cellvizio, dubbed the "fastest way to see cancer," reported that gastroenterologists in Japan and Germany have used Cellvizio to directly view the enteric nervous system of the digestive tract during an endoscopy procedure for the first time.
Baxter (Deerfield, Illinois) entered into a definitive agreement to acquire Gambro (Lund, Sweden), for SEK 26.5 billion, or about $4 billion at current exchange rates. Gambro makes dialysis products and therapies for patients with acute or chronic kidney disease.
It's been a long road for HeartWare International (Framingham, Massachusetts), but the company's patience and perseverance has finally paid off. The FDA has approved the company's premarket approval application (PMA) for its HeartWare ventricular assist system (VAS) as a bridge-to-transplantation (BTT) therapy for patients with end-stage heart failure. HeartWare submitted the PMA nearly two years ago (Medical Device Daily, Dec. 29, 2010).