Guilford’s Defibtech LLC finally won federal clearance to market its portable heart resuscitator in the U.S., authorities say.
Defibtech said the Food & Drug Administration approved sale of its Lifeline brand defribillator for victims of cardiac arrest, which strikes about 380,000 Americans each year and is the leading cause of death in the U.S.
The approval comes two months after Defibtech sold itself in November to Nihon Kohden Corp., of Tokyo, one of Japan’s largest makers of medical equipment, including a rival life-saving device.
Founded in 1999, Defibtech’s business model is tied to a 2004 Federal Aviation Administration mandate that commercial carriers must have an automated external defibrillator (AED) on board.
Defibtech also targets non-traditional markets, such as hotels, restaurants, schools and gyms, prices its bright yellow and black hand-held units for around $1,400 compared to $3,500 for the competition.
