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Daily news and top headlines for manufacturing professionals

FDA Warns Of Major Risk With St. Jude Heart Device

February 13, 2013 12:14 pm | by The Associated Press | News | Comments

The company's Amplatzer TorqVue delivery system is used to mend a type of heart defect that causes holes in the upper chambers of the heart. St. Jude recalled all batches and models of the device Jan. 13 after a small number of incidents where the delivery system's wire fractured during surgery.

Components, Characteristics And Device Implementation

February 11, 2013 5:49 pm | by Luis Puebla, Applications Engineer, Freescale | Articles | Comments

The user interface needs to be as simple as possible, yet provide the physician with accurate feedback. The device must be robust and able to be used for extended periods of time. As shown in Figure 1, the patient is required to wear a mask throughout the night.

Thousands Of Women Sue Over Surgical Mesh

February 11, 2013 8:44 am | by Kate Brumback, Associated Press | News | Comments

While many women benefit greatly from the mesh surgery, the Food and Drug Administration has warned some can suffer complications, and many women have sued, claiming manufacturers should have warned of potential harm. But some doctors have said the FDA's warning — and the lawsuits against the manufacturers — are misguided.


Watson's Medical Expertise Offered Commercially

February 11, 2013 7:58 am | by Jim Fizgerald, Associated Press Writer | News | Comments

The Watson supercomputer is graduating from its medical residency and is being offered commercially to doctors and health insurance companies, IBM said Friday. IBM Corp., the health insurer WellPoint Inc. and Memorial Sloan-Kettering Cancer Center announced two Watson-based applications — one to help assess treatments for lung cancer and one to help manage health insurance decisions and claims.

Tranzyme Board To Explore Sale, Other Alternatives

February 8, 2013 10:25 am | News | Comments

The Durham, N.C., company said Friday it has not decided on any specific alternative, and it has no time frame for completing its review. Tranzyme has no drugs on the market. It said in December it would end a mid-stage study of a treatment for diabetic gastroparesis because it failed to do better than a placebo.

OMEGA Introduces High Temperature Pressure Data Logger

February 6, 2013 3:02 pm | Product Releases | Comments

The OM-CP-PR140, from Omega Engineering, is a pressure data logger designed for use in autoclave validation and mapping. This rugged device can withstand temperatures up to 140°C (284°F) and is completely submersible (IP68). The OM-CP-PR140 is built with a precision stainless steel pressure gauge.

Boston Scientific Plans Job Cuts

January 29, 2013 10:31 am | by Tom Murphy, AP Business Writer | News | Comments

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.

Q&A: Navigating A Regulatory Minefield For Medical Devices

January 18, 2013 11:20 am | by Joel Hans, Managing Editor, | Articles | Comments

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.


Stryker Buying Trauson For $764 Million

January 17, 2013 2:25 pm | by The Associated Press | News | Comments

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.

FDA Sends St. Jude Warning Letter Over Calif. Plant

January 15, 2013 8:25 am | News | Comments

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.

Welding Quality Systems To Support The Medical Device Industry

January 14, 2013 8:26 am | by Salay Stannard, Joining Technologies, Inc. | Articles | Comments

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 Acquires American Fluoroseal Corporation

January 4, 2013 3:50 pm | News | Comments

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.

Medicare Overpaying For Back Braces

December 19, 2012 1:19 pm | by Ricardo Alonso-Zaldivar, Associated Press | News | Comments

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.


Total Fleet Solutions And The Miner Corporation Join Forces

December 19, 2012 12:13 pm | News | Comments

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.

Baxter To Buy Gambro For $4B

December 4, 2012 8:21 am | News | Comments

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.

FDA Pledges Support For Med Tech Initiative

December 3, 2012 11:45 am | News | Comments

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.

Court To Decide If Human Genes Can Be Patented

December 3, 2012 8:12 am | by Jesse J. Holland, Associated Press | News | Comments

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.

Wright Medical Buying BioMimetic For $190M

November 19, 2012 12:26 pm | News | Comments

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: Court Upholds Medtronic Patent Ruling

November 14, 2012 8:08 am | News | Comments

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.

PerkinElmer Buys Chinese Test Developer

November 13, 2012 11:26 am | News | Comments

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 Paying $30M To Settle Kickbacks Case

November 2, 2012 4:15 pm | by Ken Ritter, Associated Press | News | Comments

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.

Abiomed Plunges After Disclosing Investigation

November 2, 2012 8:57 am | News | Comments

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 To Acquire Banner Pharmacaps

October 29, 2012 3:56 pm | News | Comments

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 Aims To Attract Medical Device Makers

October 26, 2012 11:17 am | News | Comments

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.

Senate: Medtronic Shaped Articles Promoting Infuse

October 25, 2012 12:02 pm | News | Comments

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.

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