But medical device giant doesn't admit wrongdoing.
Finds that 65 percent of devices were supported by one study; FDA questions research methods.
Deal takes criminal charges off the table.
Investigation targets companies’ most profitable products
Says device tax would result in ‘unintended consequences’
Executives claim move is key part of Mesa’s growth strategy
Expansion improves company's capacity, workflow and output
New division will have its own staff
Company attempting to offset declining sales with second major acquisition in seven months
Company prepares for orthopedic sector recovery
Start date moved to 2011.
Change would lessen impact on small companies
Company hopes to have ten sites in U.S. and Israel by year's end
Merger increases DePuy's selection of hip-bearing offerings
Martin Rothman has served as director of cardiac research and development at London Chest Hospital.
Senator sends letter to 33 medical organizations.
Allegations involve improper payments to Greek healthcare officials.
But spinoff Data Sciences International Inc. remains in business.
Agency said it received reports of malfunctions
Michael Coyle previously worked for St. Jude Medical as president of Cardiac Rhythm Management.
Indiana-based firm has 15 days to respond to agency.
All domestic units have been repaired, the firm said.
Groundbreaking is planned for the fourth quarter of this year.
Report finds it took the agency at least four years to remove convicted researchers.
Firm has two reprocessing facilities, in Arizona and Florida.
3D Recon to help in treatment of aortic aneurysms.
Remaining shares will be worth $12.65 each.
Agency cites poor manufacturing standards.
Almost 72 percent expect sales to increase next year.
Move follows another that provided the firm with $1.2 million in financing from Dorsky Worldwide Corp.
Puts medical device tax at $19 billion over 10 years.
Minneapolis, Minn., firm responds with corrective action; agency to re-inspect.
Deal, worth more than $1 million, gives BayerMaterialScience accessibility to permanent, biodegradable surface modification techniques.
OEM plans on hiring 1,400 people within five years.
Lance Berry is promoted from vice president and corporate comptroller.
Agency received six adverse event reports.
Automated external defibrillators
Leesburg, Va., firm enters German spine market.
Firm was not following federal manufacturing standards.
Overall, angel investments are down 27 percent compared to a year ago.
Purchases bone-cutting products from Mutoh Co. Ltd. and Synergetics U.S.A. Inc.
Array of products come from startups to multi-billion-dollar companies.
At NASS annual meeting, advocacy chair says healthcare reform is necessary, but disagrees that spinal surgeons should be compensated less.
TurboXb embedded computer to power data-delivering device.
The Food & Drug Administration falls far short of its own goals for clearing medical device 510(k) clearance applications, according to an exclusive report from MassDevice.com.
Yet another defunct orthopedic device developer is acquired. Where does that leave the rest of the field?
Reason is dispute over proposed medical device tax.
The San Diego, Calif.-based firm also announced a slew of promotions.
Investigation by Department of Justice involved product advisories issued by Guidant in 2005.
Firm expects FDA approval for the PROMUS Element System in 2012.
Authorization gives access to $500 million.
Recessions force OEMs to take another look at their business models.
Former president, three sales managers could face jail time, significant fines if convicted.
Agency commissioner and CDRH acting director implement changes.
St. Paul firm decides to streamline its operations.
At MPO Symposium, report shows most medical device firms don't use software applications for TPLC.
Will continue to serve on board of directors.
HandyLab instrumentation technology will support BD's molecular diagnostics strategy.
Agency issues 17 warning letters to ambulatory surgical centers.
Healthcare reform proposal calls for $4 billion annual tax.
Report finds proceedings took 26 days to 11 years.
Singapore, based-firm also has expanded Tijuana, Mexico, campus.
Pays $400 million in cash for eye-care firm.
Report says United States, Europe and Japan make up 78 percent of the market.
Agency claims Deerfield, Ill,-based firm is using misleading device labeling and isn't complying with federal manufacturing standards.
Finds industry is slow to adapt to Internet platform.
Wechsler Joins Estech as Medical Director; EnteroMedics Taps Co1hen as Senior VP; Boston Scientific Co-Founder Named to Nanobiosym Global Advisory Board; SafeStitch Medical Appoints Director; Vivakor Names Former GE Healthcare Executive as Director; Sec
Abbott Nutrition, Hospira Inc. report 122 incidents from Electri-cord Manufacturing Company power cords.
Purpose is to be prepared in case of a catastrophic emergency.
CIRTEC Medical Systems to operate in Massachusetts, Minnesota and California.
Moves come as commissioner seeks to make changes at agency.
Despite some calls for change, device companies stand behind FDA
Firm showcased V-Loc at AdvaMed 2009.
Officials say there’s still time to adjust the device fee in reform legislation.
Ernst & Young report shows growth stalled in the first half of 2009.
Products involved focus on aortic aneurysms.
Firm to hire more than 100 in Singapore over two years.
Says patient care, innovation, investment and jobs will suffer.
Firm to lay off 350 starting in January.
The move impacts devices manufactured from July 2002 to March 2008.
Schmidt of Capstone Partners says merger deals have been more conservative than in the past.
Change in leadership at FDA prompting changes to device review process
Reports performed aroud procedure codes for 30 highest-volume orthopedic procdures
Robust prototyping capability is key, experts say
Market forces making outsourcing relationships challenging
Avalanche of quality guidelines expected from worldwide regulatory agencies
At ODT Expo, Young said $4 billion annual tax on device firms would drive more patients to the sector.
California-based firm pays $1.3 million in cash.
Afterwards, agency will decide whether labeling changes or more clinical testing requirements will be necessary.
Amount of move not disclosed.
Lawsuits involved the use of stents for treating heart disease.
Purchase will give Covidien a boost in brain monitoring technology.
Senators, congressmen allegedly strongly urged FDA to approve ReGen knee device in 2007.
Agency experts work with local inspectors.
Funding will provide boost to Indiana's orthopedic sector
The market has been virtually untapped since demand is low.
About 360 workers will remain after layoffs.
The medical device firm said the product provides a three-month warning.
Units manufactured after May 31, 2008 are unaffected by announcement.
Healthcare reform proposal calls for $4 billion device tax.
Move comes after reports of sparking, fires around plug.
Acquisition to boost neurodiagnostic device business.
Group also responds to President Obama's joint session speech on healthcare reform.
The purchase is another in a string by Abbott Park, Ill.-based firm.
The acquisition will help boost Abbott's vision care business.
The case involves the ProDisc-L artificial disc replacement device.
Company to manufacture Percutaenous Hepatic Perfusion System there.
Barrett now chairman and CEO; board moves made.
Increases take effect Oct. 1.
The Minneapolis, Minn.-based firm has re-organized the company into two groups.
Patient infringement suit was filed in 1996.
Saffran won earlier suit against Boston Scientific Corp.
Medical device manufacturers would be required to follow rule.
But the company is staying mum on how many employees have been laid off.
Decision involves RENASY EZ product portfolio.
Dr. Jeff Shuren to serve as acting director.
Addresses the issue of when medical device companies can be sued.
The firm also must hand over 11 percent royalties through 2018.
Firm to move manufacturing operations to China.
Firm to expand Positron Emission Tornography business.
Firm doesn't anticipate acquisition will have material impact on fiscal 2009 outlook.
Could face jail time and $100,000 fine.
Agency cites medical device giant in warning letter.
Department of Justice alleges off-label use of devices to treat atrial fibrillation.
Acquisition opens doors in orthopedics market.
The dispute focused on heart stent technology.
Amounts to about a 60 percent increase including cash incentives, salary boost and stock.
Medtronic, Boston Scientific, St. Jude included.
Appointee is president of Roush Life Sciences in Salem, N.H.
The medical device maker is providing replacement products for free.
Carefusion is expected to launch in late summer.
Will be available on the market first in Japan
The U.S. Food and Drug Administration cites non-conformities with Good Manufacturing Practice.
HealthTronics has agreed to buy Endocare.
A key result of the study shows differences between medical devices and pharmaceuticals.
An update to the recommended rules will go into effect July 1.
Purchase broaden's endovascular device company's neurovascular product portfolio.
The leadership change is slated for July 13.
Boston Scientific study shows a 29 percent reduction in death or heart failure interventions.
Margaret Hamburg will speak in September at the annual RAPS meeting.
Prosecutors charge the orthopedic device maker with promoting off-label use of bone filler Norian XR.
Survey finds optimism among risk-taking investors.
Urge Obama to "consider the value" of the technology
Bill would create national database of patients receiving artificial joints
The gadget allows sharing of information between patients and healthcare providers.
Seattle, Wash.-based company focused on developing cortical stimulation therapies.
Research shows no lab inspections are planned for this year.
Purchase adds Pipeline Embolization Device and Alligator Retrieval Device to portfolio
Major industry groups collaborate to help cut $1 trillion in healthcare costs.
Announcement made during webcast on the OEM's diabetes business.
Cites reorganization, slower sales and patent settlement
The initial focus will include cardiology, orthopedic and pediatric devices and technology.
A medical device maker is included in the list.
Edinburgh firm looks to expand its products in the critical care arena.
Landmark study reveals wide disparities in achievement.
The medical device giant plans to cut up to 1,800 positions by the end of June.
Data released at BIO 2009 reveals deteriorating worldwide climate for biotechnology.
New FDA chief is only the second woman in 100 years to hold the post.
Agency cites lack of proper documentation on oxygen concentrator complaints.
The conclusion reverses research in 2006 by the same scientists.
The transaction is expected to be completed by June 30.
Legislation would open manufacturers whose products have been OK'd by the FDA to lawsuits.
The request comes on the heels of a competitor's agreement with the state.
The agency points to manufacturing issues involving the company's Safire ablation catheter.
FDA rules hamper the progress of repairs.
The move brings the Illinois-based company to 430 employees.
The discussion comes on the heels of scientists complaining of a flawed approval process.
Say they're looking forward to working with Kathleen Sebelius on healthcare reform.
Thoracic surgeons had the highest rate of serious complications, pegged at about 2.5 percent.
IZ Medical Product's markers can be used across a broad range of medical specialties.
The government is investigating the company's ultrasound stimulation product Exogen.
Congressional investigation sparks alert.
The market could reach $23 billion by 2014.
The medical device maker expects to hire 300 people during five years.
Twenty five types will be reviewed by the federal agency.
One person died from failure, according to the company.
The two technology companies are development ways for doctors to remotely monitor patients.
Stryker avoided charges and fines by cooperating early on.
The Ohio-based company is spinning off its clinical, medical products divisions as a separate entity.
The Illinois-based medical device maker is looking to increase its profits.
Projects will focus on advanced medical technology.
The product was pulled from the market in 2007, but some people still have them implanted.
Problems include shocks, blown fuses and unexpected shutdowns.
The companies are given the most dire of designations.
The orthopedic implant company received CE Mark approval in 2008.
The law calling for the identification system was approved in 2007.
The medical device maker is being investigated for promoting off-label use of human growth products.
Association responds to threats of regulation by senators.
Medtronic acquisitions are the most recent examples.
Agency cites company in response to March and May inspections.
Some are worried that innovation will be stifled.
The medical device maker will buy CoreValve and Ventor Technologies.
They pleaded guilty to promoting off-label use.
The resignation came after an internal audit found double billing of insurance companies.
The firm suffered a huge defeat when the FDA rejected its lead project.
HeartWare's operation will be folded into Thoratec's cardiovascular division.
The measure calls for comparative effectiveness of procedures funded by government programs.
Navistar Thermocool catheters treat atrial fibrillation.
The companies were cited for various violations.
A July inspection resulted in these conclusions.
Some researchers were receiving millions without disclosing it.
The company is also planning on building in Costa Rica.
The companies will continue to work together.
The former Democratic Senate majority leader owed more than $140,000 in back taxes.
The North Carolina medical device maker received economic incentives.
The medical device maker will release its quarterly earnings in two weeks.
San-Antonio based Kinetic Concepts claimed the company infringed on patents for a negative pressure wound therapy system.
The companies are staying mum on the figures.
The purchased solidifies Moog's position as a manufacturer of infusion therapy equipment.
The company is bracing for "potential for slower demand" in the first quarter of this year.
The company has high hopes for its cardiac rhythm management business this year.
Federal scientists earlier complained about mismanagement.
Results were published in the New England Journal of Medicine.
Arbios Systems was working on creating a kidney dialysis alternative.
The document expresses terrorism fear.
The medical device maker says the line could help patients at risk for acute kidney injury.
NMT Medical is saying the whistleblower slandered the company.
The agency wants the company to have an outside audit.
The Illinois company will pay $22 a share in a tender offer.
Company will make initial payment of $225 million.
Steritec Products is pulling some of its products.
A recall of Striker devices followed.
They claim agency officials say trying just isn't worth it.
FDA: Many problems discovered by complaints
Journal article shows devices work equally well for youths, elderly
The company plans to expand to rural communities
Minn.-based medical device maker sued German firm
Medical device maker was sued over defibrillator products
Langhorne-Pa.-based Power Medical Interventions is cited
Firm makes syringe-style infusion therapy pumps
Agrees with lower court on patent infringement decision
Patients are putting off procedures due to the weak economy
Patients allege inflammatory reactions after eye surgery
Send comments electronically via www.regulations.gov
FDA says the company didn't follow through on corrective action
China-based company will hold the majority stake in the new firm
News » 2009
