Medical Devices
FDA panel backs Medtronic's MRI-safe pacemaker
Mar 19, 2010 17:12 EDT
Federal health experts are recommending approval for a Medtronic pacemaker designed to be safely used with MRI scanners.
FDA panel backs Medtronic's MRI-safe pacemaker
Mar 19, 2010 17:12 EDT
FDA panel unanimously back approval for Medtronic's scan-friendly pacemaker. Federal health experts are recommending approval for a Medtronic pacemaker designed to be safely used with MRI scanners.
Summary Box: FDA to review already-OK'd device
Mar 19, 2010 14:48 EDT
Summary Box: FDA to review already-approved knee implant, but device maker fights back. WHAT HAPPENED: In a rare move, the Food and Drug Administration has decided it will again review Menaflex, a knee implant it had approved in 2008. The agency plans to convene a panel of experts next week to revisit the safety and effectiveness of the device.
Summary Box: FDA to review already-OK'd device
Mar 19, 2010 14:48 EDT
WHAT HAPPENED: In a rare move, the Food and Drug Administration has decided it will again review Menaflex, a knee implant it had approved in 2008. The agency plans to convene a panel of experts next week to revisit the safety and effectiveness of the device.
FDA prepares to reassess much-debated knee implant
Mar 19, 2010 13:07 EDT
A medical device company at the center of a highly controversial Food and Drug Administration approval is pushing back against the agency's plan to re-evaluate the implant.
FDA prepares to reassess much-debated knee implant
Mar 19, 2010 13:07 EDT
Device maker Regen Biologic challenges FDA plan to reassess highly-contested knee implant. A medical device company at the center of a highly controversial Food and Drug Administration approval is pushing back against the agency's plan to re-evaluate the implant.
Panel backs new use of Boston Scientific devices
Mar 18, 2010 19:00 EDT
COLLEGE PARK, Maryland (Reuters) - Boston Scientific Corp on Thursday moved closer to winning U.S. clearance to promote implanted cardiac devices for patients in earlier stages of heart failure.
FDA panel backs implant for mild heart failure
Mar 18, 2010 18:11 EDT
Federal health advisers said Thursday an electronic heart implant should be approved for a large group of heart-disease patients who currently aren't eligible for the device.
FDA panel backs implant for mild heart failure
Mar 18, 2010 18:10 EDT
FDA panel recommends Boston Scientific's electronic heart device for less-severe heart disease. Federal health advisers said Thursday an electronic heart implant should be approved for a large group of heart-disease patients who currently aren't eligible for the device.
Correction: Hospice-Defibrillator story
Mar 18, 2010 15:20 EDT
In a story March 15 about hospices being slow to turn off patients' defibrillators, The Associated Press reported erroneously the proportion that had a way to identify implant recipients. The study found 20 percent had a method to do so, not one in 20.
Correction: Hospice-Defibrillator story
Mar 18, 2010 15:20 EDT
Correction: Hospice-Defibrillator story. In a story March 15 about hospices being slow to turn off patients' defibrillators, The Associated Press reported erroneously the proportion that had a way to identify implant recipients. The study found 20 percent had a method to do so, not one in 20.
Public defibrillators boost cardiac arrest survival
Mar 17, 2010 17:38 EDT
NEW YORK (Reuters Health) - Wider dissemination of portable defibrillators in Japan's schools, workplaces and other public venues has increased the number of people who survive cardiac arrest, researchers reported Wednesday.
Boston Sci could resume ICD sales within 30 days
Mar 17, 2010 14:31 EDT
CHICAGO (Reuters) - Boston Scientific Corp. <BSX.N> could be selling implantable heart rhythm devices again within 30 days if no new issues arise beyond the paperwork problems revealed this week.
FDA eyes improvements for diabetics' glucose devices
Mar 16, 2010 17:16 EDT
GAITHERSBURG, Maryland (Reuters) - U.S. health regulators are taking a closer look at how well devices used by diabetics to monitor their blood sugars work, seeking possible changes for device makers to help make them more reliable.
FDA questions new use for Boston Science device
Mar 16, 2010 14:36 EDT
The Food and Drug Administration said Tuesday a heart device from Boston Scientific appears effective for a new group of patients, though questions remain about the accuracy of the company's study of the device.
FDA questions new use for Boston Science device
Mar 16, 2010 14:36 EDT
FDA reviews Boston Science request to extend device approval to mild heart failure patients. The Food and Drug Administration said Tuesday a heart device from Boston Scientific appears effective for a new group of patients, though questions remain about the accuracy of the company's study of the device.
Long-term safety of drug-coated stents questioned
Mar 16, 2010 14:03 EDT
ATLANTA (Reuters) - New research shows more patients who got drug-coated stents right after suffering a severe heart attack later died from heart-related problems than those who received older, cheaper bare-metal models.
Heart-shock device may disrupt quiet hospice death
Mar 16, 2010 03:19 EDT
If you have a heart-zapping defibrillator implanted in your chest but now are dying of something else, when do you have it turned off?
Heart-shock device may disrupt quiet hospice death
Mar 16, 2010 03:19 EDT
HEALTHBEAT: Hospices slow to help patients decide when to switch off heart-shocking implants. If you have a heart-zapping defibrillator implanted in your chest but now are dying of something else, when do you have it turned off?
FDA seeks more data on MannKind's inhaled insulin
Mar 16, 2010 02:58 EDT
BOSTON (Reuters) - U.S. regulators have requested more information on an inhaled insulin device being developed by MannKind Corp, sending the company's shares down 24.7 percent.
