The FDA is putting increased focus on approving devices faster, as it races to catch up to its European Union counterpart. But University of Pennsylvania researchers were surprised to find that the agency is actually regulating devices appropriately, while European regulators are not.
Stryker took an earnings hit during the third quarter, in part to repatriate $2 billion in cash for acquisitions and to establish an EU regional headquarters in Amsterdam, where it has moved some intellectual property. The IP transfer is expected to reduce its effective tax rate from an expected 22% in 2014 to 20% next year.
The European Union suspended shipments of EndoBarrier, an obesity device from GI Dynamics, for reasons undisclosed by the company. GI Dynamics said the situation is temporary and does not apply to product already in the hands of hospitals and distributors.
ReShape Medical revealed the first postapproval data from the EU for its nonsurgical, balloon-based weight-loss system: 42% of excess weight loss on average with a variance of 23%. But the company cautions that because of the different way the trials are designed, it won't have similar results when it releases pivotal U.S. trial data in November.
Cataracts are big business for Abbott. It's ready to roll out the latest in its line of implantable Tecnis lenses in Europe after recently receiving a CE Mark for the product, which will be used to treat cataract patients who may also have a diminished ability, due to aging, to focus on near objects (presbyopia).
In 2012, an immediate action plan as well as new medical device legislation were proposed in the European Union. This week, the Employment, Social Policy, Health and Consumer Affairs Council of the European Commission declared the action plan a success and issued its vision for upcoming legislative changes.
After a headline-grabbing breast implant scandal rocked the continent, EU regulators are considering a more stringent approach to medical device regulation, a proposal industry leaders say would hamstring Europe's successful medical device sector.
The long and colorful Poly Implant Prothèse saga is slowly drawing to a close, as prosecutors are asking for a four-year jail sentence and $128,000 fine for the CEO who presided over the sale of faulty breast implants to thousands of women.
The Poly Implant Prothèse scandal left more than 400,00 women with toxic breast implants and sparked medical device regulatory reforms across the EU, and now 5 of the company's former execs are enduring boos and hisses from wronged patients as their trial gets under way in France.
In a world in which drugmakers must meet a growing diversity of formulation demands, capsule manufacturer Capsugel has won an organic certification for a plant in France that is focused on Europe, considered the largest market for organic products.