April 25, 2011 |
The Food and Drug Administration announced Monday that it will act to ensure the government's right to impose marketing, manufacturing and safety restrictions on "electronic cigarettes," a nicotine delivery device widely billed as an alternative to cigarettes for those trying to quit and for smokers who can't light up. In a letter posted to the FDA's website Monday, Dr. Lawrence R. Deyton, director of the FDA's Center for Tobacco Products, said...
April 20, 2011 |
Despite recalls of defective medical devices that have caused devastating injuries and millions of dollars in medical costs, the Food and Drug Administration is under industry pressure to speed up its approval process. That pressure comes as a new Government Accountability Office report criticized the way the FDA handled approval of high-risk devices, such as defective artificial hips made by Johnson & Johnson that left shredded metal in patients. More than 90,000 artificial hips were recalled last summer after studies showed that about 1 out of 8 recipients needed to have them replaced.
April 18, 2011 |
Brain tumors may soon encounter a new weapon. The Food and Drug Administration has approved a new device that uses electrical energy to kill brain cancer cells. The device, approved for those who have malignant tumors known as glioblastoma multiforme, adds a potential new alternative to chemotherapy for patients with advanced brain tumors. The device, called NovoTTF, delivers low-intensity electrical fields directly to a patient’s scalp via four electrodes. The electrical fields appear to interfere with the process of cell division, halting the tumor’s growth.
April 14, 2011 |
The Food and Drug Administration has been allowing medical devices, from hip replacements to external defibrillators, to enter the market under less stringent review processes -- and this may mean potentially unsafe devices are being used by, and even implanted in, unsuspecting patients, a new report finds. According to the report released Wednesday by the Government Accountability Office, medical device makers don't have to go through the FDA's stringent premarket approval process if they can show that their product is roughly equivalent to another device already on the market.
February 15, 2011 |
A disproportionate number of medical devices recalled because of possible links to serious health problems or deaths ? including external defibrillators and insulin infusion pumps ? were approved under an abbreviated process that did not require advance testing on patients, according to a five-year study of such recalls. More than 70% of the 113 recalled devices were cleared for market under a shorter Food and Drug Administration review because they were deemed similar to products already on the market, the study found.
February 9, 2011 |
Responding to the needs of badly wounded war veterans, federal officials said Tuesday they were accelerating reviews of a science-fiction-like robotic arm controlled by a computer chip on the brain. The device would make the use of prosthetic arms, hands and fingers seem almost natural by using a microchip implanted on the brain to record and decode signals to neurons that control the prosthesis. In a dramatic video accompanying the announcement by the Food and Drug Administration, the prosthetic arm wielded pliers and picked up a clothespin to demonstrate its dexterity.
January 17, 2011
Healthsense, a technology company based just outside Minneapolis, uses wireless sensors to provide an early warning system for health problems among the elderly or frail. The sensors send out an alert when they detect trouble ? a fall, for example, or a significant change in sleep patterns. Demand for this kind of innovation is soaring, and companies are responding with a host of new products that can make care less costly and more effective. It's a trend that's been gaining momentum for several years, but it's been helped along by the healthcare law enacted last year.
December 16, 2010 |
The Food and Drug Administration warned the nation's dietary supplements industry Wednesday against spiking its products with steroids, prescription drugs and other prohibited substances. The warning was the latest salvo in a long-running battle between federal regulators and an industry that is held to far less rigorous health and safety standards than those imposed on makers of pharmaceuticals and medical devices ? thanks in part to powerful friends in Congress. Unlike drugs, dietary supplements don't have to be proven safe before being sold, and manufacturers can make general claims about health benefits.
December 15, 2010 |
Emily Zabor graduated with a master's degree in biostatistics from the University of Minnesota this year, right in the middle of the worst job markets in decades. No problem. "I expected to have good prospects," Zabor said. "I knew it was a field that was growing. " Even before graduating, Zabor accepted a $75,000-a-year job at Memorial Sloan-Kettering Cancer Center in New York City, helping to design and analyze clinical studies. In fact, all 21 students in Zabor's program have found work, with drug companies, medical device firms and public health agencies.
November 22, 2010 |
Medical innovation saves lives, but each drug and device requires careful scrutiny by the Federal Drug Administration before being deemed safe to market. But does the federal agency take too long in its approval process? Dr. Josh Makower says yes. The consulting professor of medicine at Stanford University co-wrote a study of 200 medical technology companies and reports his findings in this column by Nicole Brochu of the South Florida Sun Sentinel . The column reads in part: "For low- and moderate-risk devices, the process to navigate the FDA took companies on average three months to two years longer for a green light than it did for a similar approval from European regulators.