The agency says it hopes to offer guidance to the Medical Device Innovation Consortium, a new industry-backed group that aims to simplify the design and testing of medical devices. Medical device makers have criticized the FDA for an overly burdensome review process, which they claim slows down development of important new therapies.
The Supreme Court announced Friday it will decide whether companies can patent human genes, a decision that could reshape medical research in the United States and the fight against diseases like breast and ovarian cancer. The current case involves Myriad Genetics Inc. of Salt Lake City, which has patents on two genes linked to increased risk of breast and ovarian cancer.
Medical device maker Wright Medical Group Inc. plans to buy BioMimetic Therapeutics Inc. in a $190 million cash-and-stock deal to help grow its foot and ankle business. The companies said Monday the deal could grow to $380 million if some incentives are met.
Edwards Lifesciences Corp. said Tuesday a federal appeals court upheld a ruling that Medtronic Inc.'s CoreValve System infringes on a patent belonging to Edwards. Edwards said the U.S. Court of Appeals for the Federal Circuit upheld the patent and an April 2010 ruling by a federal jury, which found that Medtronic was willfully infringing on the patent.
Health and industrial sciences company PerkinElmer Inc. said Monday it acquired Haoyuan Biotech Co., a Chinese company that makes diagnostic tests for infectious diseases. PerkinElmer said it agreed to pay about $38 million for the deal, and it could make additional payments based on sales of Haoyuan Biotech' products.
Orthofix International NV agreed to resolve claims that Blackstone Medical Inc. provided surgeons with travel, entertainment and benefits including sham consulting, royalty and research deals, according to a statement from the Justice Department civil division in Washington, D.C.
Shares of Abiomed Inc. tumbled to annual lows Thursday after the heart device maker said U.S. attorneys are investigating the marketing and labeling of its Impella 2.5 system. Abiomed said it was informed of an investigation by the U.S. Attorney's Office for the District of Columbia on Friday.
Patheon Inc., a leading provider of contract development and manufacturing services to the global pharmaceutical industry, today announced that it has entered into a definitive agreement with VION N.V. to acquire Banner Pharmacaps, a specialty pharmaceutical business dedicated to the research, development and manufacturing of unique gelatin-based dosage forms.
South Dakota officials plan to attend an event in Minnesota next week as part of an effort to attract companies that make medical devices. Representatives of the Governor's Office of Economic Development and officials from Aberdeen, Mitchell, Vermillion and Watertown will attend the Medical Design and Manufacturing Exposition in Minneapolis on Oct. 31 and Nov. 1.
Medical device maker helped write and edit medical journal articles attributed to outside physicians, which downplayed the risks of the company's best-selling bone graft, according to a report by Senate investigators. The Senate Finance Committee says Medtronic did not disclose its role in shaping the articles, which helped turn the Infuse bone graft into an $800 million a year product.
Just as it’s illegal for you and me to print money, but perfectly legal for the government to print money, there may come a time when the government deems it necessary to analyze your DNA for reasons of “efficiency” or “cost-effectiveness.”It is truly amazing how rapidly a feat which was once hailed as one of the most difficult achievements in the history of humanity is now something that may cost as little as $1,000 in a few years.
Medical device maker Stryker Corp. said Tuesday that it reached a deal to buy privately held Surpass Medical Ltd. for $100 million in cash, plus up to $35 million in milestone payments. Stryker said the addition of Surpass expands its product lineup in the fast-growing neurovascular market, while also broadening its stroke care product offerings.
Medical device maker CareFusion Corp. said Monday it agreed to buy Intermed Equipamento Medico Hospitalar, a Brazilian respiratory technology company. CareFusion said Intermed designs, makes and sells ventilators and respiratory care devices used in hospitals in Brazil and Latin America.
With today’s 21st Century technology and the speed and accessibility of data or information from the internet, medical device manufacturers are faced with unique — and at times unprecedented — trends in meeting consumer needs as well as global regulatory requirements.
Medtronic Inc. will buy China Kanghui Holdings for $816 million, helping it expand in one of the world's fastest growing medical device markets. China Kanghui Holdings makes orthopedics devices, specializing in trauma, spine and joint reconstruction.
Scientists reported Thursday that they succeeded in creating tiny medical devices sealed in silk cocoons that did the work they were designed for, then dissolved in the bodies of lab mice. It's an early step in a technology that may hold promise, not only for medicine, but also for disposal of electronic waste.
Blood analysis systems developer Abaxis Inc. said Wednesday it will receive $17.25 million from medical test maker Cepheid Inc. as part of a patent litigation settlement. Abaxis said the litigation focused on several of its patents tied to reagent and chemical compositions and processes. All claims against Cepheid will be dismissed as part of the settlement.
One-of-a-kind industry event Medical Manufacturing Innovations (MMI Toronto) 2012, which takes place October 24-25 at the International Centre in Mississauga, has unveiled a dynamic conference line-up. Conference sessions will cover hot topics including metal injection molding, additive manufacturing applications, and advanced multi-material molding processes to help provide solutions and pertinent education to the industry.
Medical and security imaging equipment maker Analogic Corp. said Thursday its net income more than doubled in the fiscal fourth quarter on greater sales of ultrasound and security products. Analogic said its new products, a larger direct-sales force, and increased efficiency helped its results.
Covidien said Wednesday it will close the plant in Seneca over the next three years as it moves operations to Costa Rica. The plant makes elastic hospital products, medical bandages and surgical supplies. It employs about 595 full-time and temporary contract employees.
U.S. attorney's spokesman Thom Mrozek says 50-year-old David Ji of Irvine pleaded guilty Monday to charges of illegally distributing a drug that the Food and Drug Administration has not approved for distribution. The version of the drug distributed through DNP International Company, Inc., contained the human growth hormone somatropin.
Androgel is one of a growing number of prescription gels, patches and injections aimed at boosting the male hormone that begins to decline after about age 40. Drugmakers and some doctors claim testosterone therapy can reverse some of the signs of aging — even though the safety and effectiveness of such treatments is unclear.
Federal prosecutors say a medical supply company from Mississippi will pay almost $1.8 million to end fraud claims in Alabama. A settlement was filed Wednesday in Birmingham in a lawsuit involving Pinnacle Medical Solutions of Southhaven, Miss.
The Federal Trade Commission has long held that brand-name pharmaceutical companies may not pay generic-drug companies to stay out of the market. To its dismay, the FTC has had great difficulty convincing the courts that its dim view of such “reverse payments” is correct.
One clever approach to handling a particular recurring deviation was to have a pre-printed form. The investigation was already written with the exception of the slight nuances, which were accommodated by blanks. This "Mad Lib" approach was completed in a matter of minutes, and a quality assurance (QA) approval was handily secured.