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October 31, 2008
Violations uncovered during inspection of plant
Suit comes on heels of FDA investigation
October 30, 2008
Two Senate committees investigating ties between Columbia University, Cardiovascular Research Foundation
Company leased space in Research Triangle Park
October 29, 2008
Company given one-year extension on patent
Official claims FDA must shift its approach on imports
October 28, 2008
Company filled orders without testing some devices before shipping them
N.Y. hedge fund also eyeing business software firm
October 27, 2008
Setback could delay launch in the U.S.
Ruling allows company to continue expanded evaluation
October 24, 2008
Woman claims surgeon used the device without her consent
Company holds slightly less than half the US market for drug-coated stents
October 23, 2008
Manufacturing problems uncovered during inspection
Both brands fared well at restoring blood flow to the heart
October 22, 2008
Lawmaker suggests equal regulatory oversight be applied to medical device DTC advertising as to pharmaceuticals
Company did not establish certain manufacturing control procedures for generator kit
October 21, 2008
Company made significant changes to device without submitting premarket notification
Devicemakers that submit ISO reports could avoid agency inspection
October 20, 2008
Decision leaves $703 million award against company intact
Expert predicts chemical will be a concern for industry
October 17, 2008
FDA claims unapproved device lacks safety and effectiveness data
Favorable patent dispute ruling could give heart stent $114 million sales boost
October 16, 2008
Program designed to cut costs
FDA updates guidance for makers of ultrasound equipment and intravascular administration sets and accessories
October 15, 2008
Congress agrees to extra money
Credibility of the industry is at stake
October 14, 2008
FDA cracking down on conducting device clinical trials
Purchase price was $78.4 million in cash
October 13, 2008
Report will likely re-categorize Class II devices
Notification relates to the improper connection of its sutureless connector intrathecal catheters
October 10, 2008
Despite multiple lawsuits involving recalled device, company insists it acted responsibly
Medical device manufacturers are hesitant to participate
October 9, 2008
Hiring in the medical device field has evolved into a recruiter's market
Suit claims alleged kickbacks were
October 8, 2008
Agency clarifies December 2007 health notification on use of RF ablation devices
Death rates lower for patients receiving drug-coated stents, study finds
October 7, 2008
Company to cooperate with inquiry
Private investment in sector remains strong
October 6, 2008
Medical device companies push to ensure technology is not targeted by federal cost-cutting efforts
Actions follow cost-cutting plan announced in April
October 3, 2008
Facility to become operational in 2011
Company hopes to resolve issues with regulators so it can launch its next-generation device
October 2, 2008
New warehouse and distribution facility underway
FDA, University of Pennsylvania sign memorandum of understanding
October 1, 2008
Deal worth $865 million
Invitrogen still hopeful $6.7 billion acquisition will occur
Judgement caps 11-year patent battle with Medtronic and Boston Scientific
