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December 30, 2008
Purchases Axsun Technologies Inc. for $21.5 million in cash
The company was sued over a heart valve component agreement.
The company is awaiting approval from shareholders, Bermuda court
December 29, 2008
The products use two methods to treat the condition
The alert follows a warning letter, which was issued in March
The St. Paul-MN company is acquiring Radi Medical AB and MediGuide Inc.
The program, which begins April 1, mandates a boost in user fees
The heart valve maker is taking this action after legislation has been introduced by an Iowa senator.
December 23, 2008
The Bermuda-based healthcare product company's next step is to train healthcare providers.
December 22, 2008
The review is continuing after Michael Gluk has left the Austin, TX-based company.
The acquisition of the Uppsala, Sweden-based company gives St. Jude the opportunity to develop a global vascular closure device market.
The FDA says the Somerville,NJ-based company did not document potential sealing problems with the Strattice device.
December 19, 2008
But a study finds that the mortality death increases slightly after three years.
Claims Engenex negative pressure wound therapy is too closely based on KCI’s proprietary Vacuum Assisted Closure, or V.A.C., Therapy System.
The company will fire 71 employees, a Web site says.
Research finds physicians go with medical devices they're familiar with.
December 18, 2008
The Advanced Medical Technology Association is supporting Japan on its updated medical device review process.
Abbott Labs bought the remaining stake in Ibis for $175 million
The FDA is saying two unapproved medical devices could cause injury or death.
December 16, 2008
Move is designed to boost the company's surgical care business
Import alert affects heating pads produced by Teamedics Manufacturing
Company failed to notify FDA when device broke
In Singapore, ads cannot use testimonials from health professionals
December 15, 2008
Fuji System accused of failing to validate its processes for silicone tubing extrusion
Patients who have had previous pocket procedures are most at risk
Kinetic Concepts is filing more claims against Smith & Nephew in an ongoing patent infringement lawsuit.
A Minnesota state senator wants medical device makers to to publicly report gifts to doctors.
December 12, 2008
A just ruled that Medtronic was in the wrong for infringing on a patent for artificial discs.
December 11, 2008
The FDA has decided a handgun meant for the elderly is not a "medical device."
GE Electronic imaging is planning to slash costs and jobs, but executives are staying mum on details.
The FDA has issued a warning letter to Innovative Neutronics after the medical device maker failed to act on agency mandates.
The FDA is closely watching medical devices containing BPA.
December 10, 2008
Medtronic is denying responsibility for the death of a California woman.
Three companies are investing $11 million in Endoscopic Technologies.
A senator from Ohio wants more information on imported dental implants.
A disclosure report reveals that Covidien spent $450,000 on lobbying in the third quarter.
December 8, 2008
Move expected to save the company $2 million
Company focused on health care legislation
Deal worth $1.1 billion
CEO says company will cooperate with investigation
December 5, 2008
Study finds devices being used too often in the wrong patients
Sales rep admits misbranding medical devices
December 4, 2008
Facility will manufacture surgical instruments
Two subsidiaries held liable for woman's death
Company also is moving out of a leased facility in Minnesota
Company trims staff by 5%
December 3, 2008
Additional staff, new application procedures attributed to accelerated approval time
PRIDE Industries starts medical device manufacturing effort
MDRs were not submitted to FDA
New design gives clinicians more control
December 2, 2008
New fee takes effect April 1
Slowdown is starting to affect the medical device industry
FDA finds fault with devices manufactured at Puerto Rican facility
Update designed to better meet devicemakers' needs
December 1, 2008
New office has eight American employees
Scientists claim top managers interfered with reviews of medical devices
Age and gender are important to the success of hip resurfacing, research shows
First phase of revisions to take effect Dec. 8