April 14, 2006 |
Medical device maker Medtronic Inc. said Thursday that U.S. regulators had approved a system for diabetics that continually monitors blood-sugar levels and recommends insulin doses to control them. The device, approved by the Food and Drug Administration, relays blood-glucose readings every five minutes from a sensor inserted under the skin to a pager-size pump, the Minneapolis-based company said.
April 10, 2006 |
FOR 10 minutes most days, 10-year-old Sonya Gomez stands on what looks like a gently vibrating bathroom scale. Leaning on a walker because her body has been weakened by cerebral palsy, she stands in hopes that an experimental treatment will fortify her bones and invigorate her muscles, even though she can barely tell anything's happening. "Every morning she eats breakfast while I'm getting ready. She brushes her teeth. Then she gets on the machine," says her mother, Anna Gomez, of Whittier.
March 30, 2006 |
Guidant Corp. said Wednesday that it had suspended shipments of a new heart stent in Europe and stopped enrolling patients to test the product in Japan because of factory quality problems. About 1% of Guidant's drug-coated Xience stents made at its Temecula plant didn't meet quality standards, the Indianapolis company said. It did not say how many suspect stents were implanted, but said no patients were injured.
October 14, 2005 |
Guidant Corp. told U.S. regulators that it learned of six additional failures of implantable heart defibrillators since issuing a July notice about the devices used to regulate cardiac rhythms. The failures occurred in the Contak Renewal and Renewal 2 brand of devices, the Food and Drug Administration said. The two devices were among models included in warnings Guidant sent to doctors in June.
September 16, 2005 |
Abbott Laboratories said it won U.S. approval of a carotid-artery stent for preventing strokes, beating Johnson & Johnson, the world's biggest device maker, in the race to compete with a device sold by Guidant Corp. Abbott will comply with the Food and Drug Administration's request for continued research on the device after approval, a company spokesman said.
July 19, 2005 |
Government regulators lack an effective system to monitor the safety of medical devices, which include items as diverse as incubators for premature babies, surgical clamps and cardiac pacemakers, a scientific panel concluded in a report issued Monday. The U.S. Food and Drug Administration, which is responsible for the safety of medical devices as well as drugs, needs additional authority from Congress and better internal procedures, according to an Institute of Medicine panel.
June 30, 2005 |
A leading supplier of a medical test used by dialysis patients said it had voluntarily placed shipments of all its products on hold in the wake of a Food and Drug Administration audit. Nichols Institute Diagnostics of San Clemente, which also sells tests to detect anemia, thyroid disorders and other conditions, said it was subjecting all products in its inventory to an additional "quality review" before shipping them. The company gave no details on the FDA inspection, which is continuing.
June 20, 2005 |
People suffering from sleep apnea aren't just tired -- they also run a higher risk of heart disease. Now researchers have found that long-term use of a breathing device during sleep can dramatically cut this risk. The therapy, known as continuous positive airway pressure (CPAP), is prescribed to keep the airway open. The condition, which causes the airway to become blocked during sleep, can make sufferers snore or wake up many times a night.
June 18, 2005 |
Under pressure after malfunctions in at least 45 implanted defibrillators, including two that are suspected in patient deaths, Guidant Corp. on Friday recalled nearly 50,000 of the devices worldwide. For the Indianapolis-based company -- its stock price dropped nearly 2% on the news -- the recall means a financial blow as it prepares to be acquired by health giant Johnson & Johnson. For many patients, it means surgery to replace suspect devices.
June 3, 2005 |
Medical device maker Guidant Corp. on Thursday stood by its decision to continue selling an implantable heart defibrillator for months after a potential flaw prompted a redesign, saying the original device was still reliable. "The reliability data showed that the original Ventak Prizm 2 DR, like the enhanced version, was a highly reliable lifesaving product," said Steve Tragash, Guidant's director of corporate communications. "Current data continues to support the reliability of this product."