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Last week, medical devicemaker Cyberonics announced that it expects its losses in 2006’s first quarter to total no more than $21.5 million — or 87 cents per share — on sales of at least $26 million.
Although Santa Barbara, Calif.-based devicemaker Inamed failed to win FDA approval to remarket its silicone gel-filled breast implants in April, the company has reported strong second-quarter implant sales totaling $64.5 million.
In an environment in which implantable defibrillators and pacemakers are being scrutinized in the wake of numerous reports of device flaws, St. Jude Medical nevertheless announced a 2.7 percent increase in its second-quarter profits fueled mostly by strong device sales.
The Senate Health, Education, Labor, and Pensions (HELP) Committee on July 20 unanimously passed the “Medical Device User Fee Stabilization Act of 2005,” legislation designed to help smaller medical technology companies afford the rising costs of device submission user fees.
A strong market for drug-eluting stents (DESs) helped rivals Johnson & Johnson (J&J) and Boston Scientific achieve impressive increases in the companies’ total second quarter revenues.
Even as Cyberonics plans the market rollout of its vagus nerve stimulator (VNS) system to treat depression in adults, critics are charging that the FDA rushed to judgment over a product that has not yet been proven to work effectively — or even at all.
Houston-based devicemaker Cyberonics won a lengthy battle last week when a premarket approval application supplement for its vagus nerve stimulation (VNS) therapy system was approved by the FDA “for the adjunctive long-term treatment of chronic or recurrent depression in adults.” The device has been approved for treatment-resistant depression (TRD) in Europe and Canada since 2001.
Abbott Laboratories will cut 700 manufacturing jobs as well as make additional cuts in its 60,000-member workforce over the next several years in an effort to reduce costs and continue to improve earnings, the company announced July 13.