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December 30, 2008

Volcano Strikes Deal to Buy Medical Imaging Component Maker


Purchases Axsun Technologies Inc. for $21.5 million in cash

ATS Medical Closes $20M Financing Deal, Settles CarboMedics Lawsuit


The company was sued over a heart valve component agreement.

Covidien Proposes Incorporating in Ireland


The company is awaiting approval from shareholders, Bermuda court

December 29, 2008

Medtronic Buys Surgical Sleep Apnea Treatments Line


The products use two methods to treat the condition

FDA Puts Import Alert on Imaging Products From Canadian Company


The alert follows a warning letter, which was issued in March

St. Jude to Pay $533M For Two Med-Tech Firms


The St. Paul-MN company is acquiring Radi Medical AB and MediGuide Inc.

Japan Unveils Plan to Speed Up Medical Device Approval


The program, which begins April 1, mandates a boost in user fees

Edwards Lifesciences To Voluntarily Disclose Payments to Doctors


The heart valve maker is taking this action after legislation has been introduced by an Iowa senator.

December 23, 2008

FDA Gives Green Light to Covidien Surgical System


The Bermuda-based healthcare product company's next step is to train healthcare providers.

December 22, 2008

ArthroCare CFO Quits Over Accounting Issues


The review is continuing after Michael Gluk has left the Austin, TX-based company.

FDA Recalls Device Alleged to Cure Cancer



St. Jude Buys Radi Medical for $250M


The acquisition of the Uppsala, Sweden-based company gives St. Jude the opportunity to develop a global vascular closure device market.

LifeCell Cited for GMP, Quality System Violations


The FDA says the Somerville,NJ-based company did not document potential sealing problems with the Strattice device.

December 19, 2008

Coated Stents Better Than Bare Metal Ones in the Short Term


But a study finds that the mortality death increases slightly after three years.

KCI Files Patent Infringement Suit Against Convatec, Boehringer


Claims Engenex negative pressure wound therapy is too closely based on KCI’s proprietary Vacuum Assisted Closure, or V.A.C., Therapy System.

Stryker Corp. Reportedly Plans to Close Israeli Business


The company will fire 71 employees, a Web site says.

Experts: Device Makers Must Help Cut Implant Costs


Research finds physicians go with medical devices they're familiar with.

December 18, 2008

AdvaMed Applauds Japan on Medical Device Process


The Advanced Medical Technology Association is supporting Japan on its updated medical device review process.

Abbott Buys Rest of Diagnostic Firm


Abbott Labs bought the remaining stake in Ibis for $175 million

FDA Recalls Two Unapproved Medical Devices


The FDA is saying two unapproved medical devices could cause injury or death.

December 16, 2008

J&J Gets Israel's Approval for Omrix Acquisition


Move is designed to boost the company's surgical care business

Hong Kong Manufacturer’s Products Placed on Import Alert


Import alert affects heating pads produced by Teamedics Manufacturing

FDA Warns Nonprofit Device Manufacturer


Company failed to notify FDA when device broke

Draft Guidance Proposes New Requirements for Device Advertising


In Singapore, ads cannot use testimonials from health professionals

December 15, 2008

Failure to Validate Processes Results in FDA Warning


Fuji System accused of failing to validate its processes for silicone tubing extrusion

Multiple ICD Replacements can Predict Complications


Patients who have had previous pocket procedures are most at risk

KCI Files New Patent Infringement Claims Against Smith & Nephew


Kinetic Concepts is filing more claims against Smith & Nephew in an ongoing patent infringement lawsuit.

Bill Would Expand Disclosure Law to Include Medical Device Makers


A Minnesota state senator wants medical device makers to to publicly report gifts to doctors.

December 12, 2008

Federal Judge Rules Against Medtronic in Patent Infringement Case


A just ruled that Medtronic was in the wrong for infringing on a patent for artificial discs.

December 11, 2008

UPDATE: FDA Kills 'prescription Pistol'


The FDA has decided a handgun meant for the elderly is not a "medical device."

GE Healthcare Imaging to Cut Costs, Jobs


GE Electronic imaging is planning to slash costs and jobs, but executives are staying mum on details.

FDA Issues Warning to Innovative Neutronics


The FDA has issued a warning letter to Innovative Neutronics after the medical device maker failed to act on agency mandates.

BPA Risk From Medical Devices Gets FDA’s Attention


The FDA is closely watching medical devices containing BPA.

December 10, 2008

Medtronic Denies Responsibility for Woman’s Death


Medtronic is denying responsibility for the death of a California woman.

Three Firms Invest $11M in Endoscopic Technologies


Three companies are investing $11 million in Endoscopic Technologies.

Reports of Contaminated Dental Imports Alarm Senator


A senator from Ohio wants more information on imported dental implants.

Covidien Spends $450K on Lobbying in 3Q


A disclosure report reveals that Covidien spent $450,000 on lobbying in the third quarter.

December 8, 2008

EnteroMedics Cuts 13 Positions


Move expected to save the company $2 million

Boston Scientific Spent $410K Lobbying in Third Quarter


Company focused on health care legislation

J & J to Acquire Breast Implant Company


Deal worth $1.1 billion

Justice Department Subpoenas Medtronic Over Infuse Bone Graft


CEO says company will cooperate with investigation

December 5, 2008

Researchers Find Poor Use of Pumps for Ailing Hearts


Study finds devices being used too often in the wrong patients

Device Sales Rep Falsifies Documents, Pleads Guilty


Sales rep admits misbranding medical devices

December 4, 2008

Exactech to Open Manufacturing Plant in Florida


Facility will manufacture surgical instruments

J&J Subsidiaries Ordered to Pay $16.6 Million in Patch Case


Two subsidiaries held liable for woman's death

SurModics Cutting 5% of its Workforce


Company also is moving out of a leased facility in Minnesota

Philips Healthcare Reduces Global Workforce


Company trims staff by 5%

December 3, 2008

Medical Devices Getting to Market Quicker in Ireland


Additional staff, new application procedures attributed to accelerated approval time

Medical Devices Now Have PRIDE


PRIDE Industries starts medical device manufacturing effort

PMI Cited for Not Reporting Malfunctioning Devices, Deaths


MDRs were not submitted to FDA

Covidien Launches Improved Magellan Safety Hypodermic Needle


New design gives clinicians more control

December 2, 2008

MHRA Proposes Modest Hike in Device User Fees


New fee takes effect April 1

Report: Hospitals Cut Spending on Devices as US Economy Falters


Slowdown is starting to affect the medical device industry

Bard Hit With Warning Letter for Poor GMP


FDA finds fault with devices manufactured at Puerto Rican facility

FDA to Update Standards Program


Update designed to better meet devicemakers' needs

December 1, 2008

FDA Opens First Overseas Office in Beijing


New office has eight American employees

Democrats Probe `Corrupted' FDA Reviews of Devices


Scientists claim top managers interfered with reviews of medical devices

Younger Men Fare Best After Hip Joint Resurfacing


Age and gender are important to the success of hip resurfacing, research shows

Additional Changes to GMP Regulations Are Under Development


First phase of revisions to take effect Dec. 8

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