Edwards Lifesciences Corp. said Wednesday that it received a warning letter from the Food and Drug Administration regarding a facility that makes products used in heart surgery. The FDA won't approve devices that could be affected by those issues until the problems are resolved.
The German drug company Bayer AG has received antitrust clearance from the Federal Trade Commission for its approximately $1.1 billion acquisition of Conceptus. Bayer announced the deal last month, saying that it would help to expand the kinds of birth control it offers.
The invention process started about three years ago when the principal at Emerson Elementary School in Madison, Karen Kepler, told a school donor on a tour that her biggest wish was to have her building accessible to everyone. All four entrances to the 93-year-old building had stairs.
Knome had been using Amazon Web Services (AWS) for computationally intensive tasks, but needed to provide a locally-installed system with full control for clinically-oriented customers, who are sensitive about security, version control, and file transfer times.
In a medical first, doctors used plastic particles and a 3-D laser printer to create an airway splint to save the life of a baby boy who used to stop breathing nearly every day. It's the latest advance from the booming field of regenerative medicine, making body parts in the lab.
Connecticut Spring & Stamping will showcase its selection of precise medical product components, such as springs and progressive stampings, at MD&M East from June 18-20, 2013. The company says its tight-tolerance springs and metal stampings are ideal for handheld surgical devices, endoscopic clip appliers, suturing devices, stable removers and more.
The researchers' work involves MRI technology. It's funded by the National Institutes of Health. They're accused of providing nonpublic information about the technology to a medical company in China and a research institution supported by the Chinese government.
A registry tracked 372 people who stuck with competitive sports after having a defibrillator surgically implanted to guard against dangerous irregular heartbeats — and found that the lifesaving device worked when needed despite the physical exertion.
Johnson & Johnson's DePuy orthopedics business plans to stop selling a couple of hip replacement systems not widely used by doctors. DePuy will discontinue both its Ultamet Metal-on-Metal Articulation and Complete Ceramic-on-Metal Acetabular systems worldwide at the end of August.
The agency said Monday that Bard will pay $48.3 million to resolve allegations that its actions resulted in false claims made to Medicare, and the company will pay another $2.2 million as part of a non-prosecution agreement. The agency says the kickbacks were paid between 1998 and 2006.
Researchers at Weill Cornell Medical College have successfully tested their novel anti-cocaine vaccine in primates, bringing them closer to launching human clinical trials. Their study, published online by the journal Neuropsychopharmacology, used a radiological technique to demonstrate that the anti-cocaine vaccine prevented the drug from reaching the brain and producing a dopamine-induced high.
Licensed practice is commonplace or mandatory in other fields, particularly construction, medicine and law, so should those individuals handily responsible for most every article we use every day also be given greater accountability for the science they practice?
Still at least a year away from the market, the 27-pound Indego is the lightest of the powered exoskeletons. It snaps together from pieces that fit into a backpack. The goal is for the user to be able to carry it on a wheelchair, put it together, strap it on and walk independently.
Medical device maker NuVasive Inc. said Monday it acquired ANC LLC, one of the key suppliers of its spinal implants, for $4.5 million. NuVasive said the companies have worked together since May 2010. NuVasive wants to handle more of its own manufacturing so it can improve its profitability. It said the acquisition won't affect its net income in 2013.
The technology indicates how rapidly the field of prosthetics is changing, benefiting patients from injured military members to victims of the Boston Marathon bombing. Practitioners say increased government research in the wake of the wars in Iraq and Afghanistan is driving some of the advances.
After attending the Marcus Evans Group’s 7th Annual OI Summit, I was delighted to see the evolution currently happening in the OI stratosphere. I was privy to a few surprises in the lineup from non-traditional players in the OI space, making this dynamic open innovations platform technologically enticing.
CareFusion Corp. said Thursday it will pay about $41 million to resolve a government investigation into marketing practices for its antiseptic ChloraPrep. The investigation also covered CareFusion's relationships with health care professionals. The company said it agreed to the settlement in principle and is also entering into a non-prosecution agreement.
The jury in federal court in Louisville awarded $6.25 million in punitive damages and $994,000 in compensatory damages on Wednesday to the family of Breanna Sadler of Vine Grove. Sadler's family sued Advanced Bionics in 2011 — about three years after the girls' cochlear implant made her ill.
The bionic legs he uses cost $60,000 a piece, are hydraulically operated and equipped with microchips and a gyroscope that sense when to relax and stiffen to help him walk. Walter Reed was involved in developing the legs, said Zach Harvey, former prosthetics chief at Walter Reed.
Hundreds of women who received faulty breast implants gathered Wednesday in a makeshift courthouse in the south of France for the fraud trial of five executives accused of using cheap industrial silicone to fill tens of thousands of implants that were sold around the world.
The Supreme Court grapples Monday with the question of whether human genes can be patented, and the ultimate answer could reshape U.S. medical research, the fight against diseases like breast and ovarian cancer and the multi-billion dollar medical and biotechnology business.
Abbott Laboratories is recalling its FreeStyle InsuLinx Blood Glucose Meters after finding that they display and store incorrect test results for dangerously high blood sugar levels. The company says the meters will display and store readings for blood glucose levels of 1,024 milligrams per deciliter or higher at much lower levels.
The company said it is taking some production lots of its DuraGen and Dural Graft Matrix products off the market because of possible "deviations from approved manufacturing processes." The products were made at a facility in Añasco, Puerto Rico, between December 2010 and May 2011 and between November 2012 and March 2013.
The high-tech helper is under scrutiny over reports of problems, including several deaths that may be linked with it and the high cost of using the robotic system. There also have been a few disturbing, freak incidents: a robotic hand that wouldn't let go of tissue grasped during surgery and a robotic arm hitting a patient in the face.
A federal appeals court says that a Johnson & Johnson heart stent does not infringe a patent held by a doctor and inventor, overturning a $482 million decision against the company. The three-judge panel said a lower court misinterpreted the company's patent and should not have ruled in favor of Bruce Saffran, a doctor from Princeton, N.J.