In a warning letter posted online Monday, FDA regulators say that the Silicon Valley company has not shown that its tests are safe or effective despite "more than 14 face-to-face and teleconference meetings" and "hundreds of email exchanges."
With the Affordable Care Act pushing more long-term treatment to be done at home, and patients demanding an increased level of autonomy when it comes to treating their conditions, many devices that were once only operated by skilled, educated technicians or physicians are now in the hands of relatively inexperienced patients.
Johnson & Johnson said late Tuesday that it will pay $2.5 billion to settle thousands of lawsuits brought by hip replacement patients who accuse the company of selling faulty implants that led to injuries and additional surgeries.
The difference between science and science fiction is a line that seems ever harder to distinguish, thanks in part to a host of astonishing advances in medical science that are helping to create a new age of promise and possibility for patients. Today cancer drugs are increasingly twinned with a diagnostic device that can determine whether a patient will respond to the drug based on their tumor’s genetic characteristics.
Medical products maker CareFusion said Monday it will buy GE Healthcare's Vital Signs unit for $500 million in a deal that expands its manufacturing capacity and nearly doubles the revenue of its specialty disposable products business.
Federal health officials say that defects in some Medtronic devices used in heart procedures are severe enough that they could cause serious injury or death. The warning covers about 15,000 recalled guidewires, which are inserted through an artery and used to guide other devices into place, such as stents to hold open blocked arteries.
Remote presence robots are allowing physicians to "beam" themselves into hospitals to diagnose patients and offer medical advice during emergencies. A growing number of hospitals in California and other states are using telepresence robots to expand access to medical specialists, especially in rural areas where there's a shortage of doctors.
A French court has ruled that a German product testing company failed its duty to check and control silicone breast implants used by tens of thousands of women worldwide that turned out to be prone to leakage.
Sealed Air President and CEO Jerome Peribere said in a statement Wednesday that the business "no longer presents a strategic fit for us." He added that the company will still make packaging products for the medical and pharmaceutical industry.
When amputees take their first steps on artificial legs, that moment of triumph can be tinged with a sudden sense of disappointment that things will never be the way they were before. Paul Martino, president of a family-run Massachusetts prosthetics company, has seen it many times. Lately, he has seen it with survivors of the Boston Marathon bombing.
Reaction Injection Molding (RIM) was invented in Germany in the 1970s, and made its way to America about 10 years later. Originally used for producing automotive components, RIM is a low-pressure, low-temperature process that uses urethane thermoset resins.
The Food and Drug Administration has approved a radioactive imaging chemical from General Electric to help screen for Alzheimer's disease. The drug, Vizamyl, is an injection of radioactive material designed to highlight abnormal brain plaque in medical imaging scans.
Medical device maker Stryker will pay the U.S. government $13.3 million to settle allegations it made illegal payments to government employees in five countries. The SEC said Stryker subsidiaries made $2.2 million in illegal payments to government employees in Mexico, Poland, Romania, Argentina, and Greece between August 2003 and February 2008.
Boston Scientific Corp. says it plans to shed as many as 1,500 jobs worldwide, or about 6 percent of its work force, in an effort to cut costs. The company also says its CFO is leaving. Boston Scientific is promoting its corporate controller to replace him.
Could 3-D printing, also called additive manufacturing, revolutionize the production industry to the same extent as Ford's assembly line? When Michelangelo was asked how he sculpted the famous David statue, he's reported to have simply replied, "I just chipped away everything that didn't look like David."
The Justice Department says Boston Scientific Corp. and its Guidant subsidiaries will pay $30 million to settle allegations that Guidant knowingly sold defective heart devices that health care facilities implanted in Medicare patients from 2002 to 2005.
Achim Steiner, the executive director of the U.N. Environment Program, says the Minamata Convention on Mercury, which was formally adopted as international law last week, sends "a very clear signal" that the use of mercury in industrial processes, cosmetics and medical equipment is essentially over.
An Israeli nonprofit group has awarded a $1 million prize to a U.S.-based research team that is developing technology that allows paralyzed people to move things with their thoughts.Israel Brain Technologies presented the award on Tuesday to BrainGate.
Short term improvements in jobs or sales are like a sick person getting some medicine from the doctor and feeling better the next day. A very thorough examination of all of the vital signs might show that the patient actually has a debilitating disease that will eventually render the patient bedridden over time.
Whether launching a new product, improving a product, entering a new market, meeting customer demands, or responding to market or technology changes, manufacturers need the ability to swiftly adapt their products to satisfy new requirements or conditions.
The work is not nearly enough to prove a link, but it adds to "the biological plausibility" that BPA might affect fertility and other aspects of health, said Dr. Linda Giudice, a California biochemist who is president of the American Society for Reproductive Medicine.
The first-of-a-kind device was developed by California-based startup, Nanostim, with funding from St. Jude. The Minnesota-based device giant also said it would acquire of the smaller company for $123 million, under a previously negotiated option agreement between the two companies.
The artificial "man" is the subject of a Smithsonian Channel documentary that airs Sunday, Oct. 20. Called "The Incredible Bionic Man," it chronicles engineers' attempt to assemble a functioning body using artificial parts that range from a working kidney and circulation system to cochlear and retina implants.
The Human Brain Project, co-funded by the European Union, plans to use supercomputers to model the brain and then simulate drugs and treatments for diseases that cost hundreds of billions of euros annually in Europe alone.
Unfortunately, because innovative ideas are ones no one else has, we can’t know for certain how successful those ideas will be. Likewise, because they are new and different, the development expense of innovative ideas is often high. The bottom line is that the risk of new and different ideas is great.