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A Morrisville medical technology firm has earned approval from the U.S. Food and Drug Administration for an implantable device that measures the amount of radiation reaching a tumor.
Bausch & Lomb set out Wednesday to assuage investor fears as retailers began pulling one of its contact lens solutions from shelves amid a U.S. government investigation over whether it is linked to a serious eye infection.
The federal government proposed stiff Medicare reimbursement cutbacks for heart products like pacemakers, defibrillators and stents, but the cuts may be softened before a new rule is officially determined later this year, clouding the potential impact for affected companies.
Medtronic Inc., which makes defibrillators and other implantable medical devices, said Thursday the Food and Drug Administration has approved a new insulin pump combined with glucose monitoring technology, a product that paves the way for creating an artificial
pancreas.
The FDA has announced a public meeting being held to consult with the agency's stakeholders and to determine whether the following two goals are appropriate for implementation in FY 2007: 50 percent of the premarket approval applications received in fiscal year (FY)
2007 will have an FDA decision in 180 days and 80 percent of the premarket notifications will have an FDA decision in 90 days.
The FDA has approved and the first implant was completed of the newest Biotronik Implantable Cardioverter Defibrillator (ICD) lead, the Linox SD active fixation, steroid-eluting lead.
Topical oxygen chambers for extremities (TOCEs) would be reclassified as Class II devices under a draft "special control guidance" issued by the FDA April 6.
Staff members at James A. Haley VA Medical Center failed to ensure cranial implants used in two recent surgeries had been sterilized, according to an investigation made public Monday.
Researchers at the California Institute of Technology are developing a kind of lab-on-a-chip which is a miniaturized, portable version of a blood-count machine.