Boston Scientific plans to cut as many as 1,000 additional jobs this year as the medical device maker expands a push to reduce operating expenses. The company's shares jumped in morning trading Tuesday, as it also reported a fourth-quarter profit and earnings outlook that topped Wall Street expectations.
Medical device manufacturing is subject to a complex network of regulations from a handful of different governing bodies such as the FDA and OSHA. If you’re planning to market and sell a new product, you have to coordinate with the equivalent bodies in every country.
Medical device maker Stryker is buying orthopaedic products maker Trauson Holdings Co. for $764 million in order to expand its business in China. Trauson's biggest shareholder, Luna Group, has agreed to tender 61.7 percent of the Trauson shares toward the offer, Stryker said. The acquisition is expected to close by the end of the second quarter.
The warning was expected after St. Jude announced in October that the plant had been visited by FDA inspectors. The staffers found inconsistencies in how the company manufactured and documented defibrillators, which are devices implanted in the chest to correct dangerous heart rhythms.
From IQ/OQ/PC (installation qualification/ operational qualification/performance qualification) documentation, to adherence to ISO 13485 quality management standards, to compliance with FDA good manufacturing practices; quality procedures and documentation pervade the entire organization.
Saint-Gobain Performance Plastics has completed the acquisition of American Fluoroseal Corporation (AFC), a Maryland based manufacturer of fluoropolymer bags for medical use and sterile sampling systems for pharmaceutical manufacturing processes. The company operates from a single location in Gaithersburg (Maryland, United States) where both engineering and manufacturing are located.
Internet sale price for a standard back brace: $99.99. What Medicare pays for the item: $900-plus. A federal report released Wednesday offers a look at how wasteful spending drives up health care costs as investigators found that Medicare paid $919 on average for back braces that cost suppliers an average of $191 each.
Yesterday, Total Fleet Solutions, a portfolio company of CI Capital Partners, and The Miner Corporation announced that they have merged to form a leading provider of facilities services and asset management solutions for retail, distribution, manufacturing, health care and hospitality companies.
Drug and medical device maker Baxter International says it will buy the privately held Swedish company Gambro for about $4 billion to broaden its dialysis product portfolio. The Deerfield, Ill., company says Gambro makes dialysis products for patients with acute or chronic kidney disease.
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.