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September 30, 2008

Cardinal Creates Spin-off, Reshuffles Execs


Clinical and medical products businesses become a separate public company

Study Finds Fewer Deaths With Drug Stents Than Bare Metal


Study conducted by the Cleveland Clinic

Devicemakers Respond to Investigations, Improve Their Transparency


Device firms step up efforts to reveal relationships with doctors

September 29, 2008

Consumer Ads for Medical Devices Subject of Senate Panel


Lawmakers, medical groups want restrictions on advertising

Varian Inc. and GE Healthcare Ink Medical Imaging Deal


Financial details not disclosed

September 26, 2008

Medtronic to Buy Canadian Device Firm


Deal worth $380 million

Medical Research Project Joins Two Firms


Active Implants pairs with InMotion to test new medical device

Cordis Wins Another Round in Patent Infringement Case


Federal judge grants motion for final judgement against Boston Scientific

September 25, 2008

Unreported Changes to Sterilization Wraps Draw FDA Warning


Company failed to get marketing clearance for sterilization wraps

Study Finds Technology, Aging Population Drive Growth in Medical Device Market


Minimally invasive medical products are steadily gaining ground

September 24, 2008

Power Medical Interventions in Deal With Intuitive Surgical


Financial details of supply agreement not disclosed

Investors Finding Shelter in Medical Devices


Sector attractive to investors seeking safety amid global economic slowdown

September 23, 2008

HealthTronics Withdraws Proposal to Acquire Endocare


Lack of dialogue prompts pullout

FDA Beefs Up Its Science Staff


Technology, market shifts challenge regulators

September 22, 2008

FDA Failing the Public Over Medical Device Inspections


Inspections do not occur as frequently as law requires

Allergy Tests Useful Before Implanting Devices


Patients with allergies to metal are at risk for recations to implanted devices

September 19, 2008

Federal Investigators to Look Into Spectranetics' Marketing Practices


Company jointly served by the FDA and US Immigration and Customs Enforcement

September 17, 2008

O’Ryan Industries Warned for Lack of Quality System Procedures


Firm has hired Eisner Safety Consultants to gain FDA compliance

New Medical Investment by Boston Scientific in Ireland


Company investing nearly $71 million in Galway plant

September 16, 2008

Tronics Buys US-based MedTech Development


Move intended to help Tronics develop more specialized medical devices

Industry Goes on Offense on Medical Device Approvals


New report stresses safety, efficacy of FDA's medical device approval process

September 15, 2008

Essel Propack Buys 74% Stake in US Medical Device Business


The enterprise value of the US firm is $10 million

Zimmer Holdings to Acquire Abbott Spine


Deal worth $360 million in cash

September 12, 2008

Massachusetts Firm Acquires MedVenture


Private equity firm leads buyout of Indiana device maker

Complaint Handling Draws Warning Letter for Contact Lens Maker


FDA claims Volk Optical overlooked numerous complaints involving the possible malfunction of diagnostic contact lenses

September 11, 2008

Supplier-Agreement Failures Result in FDA Warning


FDA cites X Spine Systems for failure to correct quality problems

Natus Medical to Buy Oregon’s NeuroCom


Deal worth $18 million

September 10, 2008

Medtronic Product Linked to Surgery Problems


'Infuse Bone Graft' linked to life-threatening complications

Final Rule Clarifies Device Labeling Changes


New FDA rule to take effect Sept. 22

September 9, 2008

Terumo Files Patent Infringement Case


Complaint alleged against company that filed two patent complaints against Terumo

Abbott Patent Extension Could Cost AngioScore Millions in Revenue


Abbott seeking patent extension through 2011

September 8, 2008

Cardinal Health Sells MedSystems Business


MedSystems is renamed Corpak MedSystems

Biosensors' Heart Stent Matches J&J Rival in Study


Stent made with biodegradeable drug coating

September 5, 2008

Boston Scientific Wins Ruling


Company receives $167 million reduction in patent verdict

Masimo Settles Patent Suits With NIR and Shaklee


All claims between the companies have been dismissed

AngioScore Eyes Abbott Catheter Patent


Patent set to expire on Oct. 29

September 4, 2008

Federal Inquiry May Hinder Plans to Expand Market for Biliary Stents


Probe threatens to upend $1.8 billion market

Warning Letter Cites Firm’s Handling of Malfunctioning Muscle Stimulators


Adverse incidents occurred after Encore Medical identified problem with muscle stimulators

Preemption Not Issue in Cochlear Implant Suit, Judge Says


Family’s claims are based on violations of federal law

Endotec's Ankle Implant Stands Up to Court Scrutiny


Court decision a victory for small orthopedic device manufacturer

September 3, 2008

FDA Adds Stent Grafts to Its Tracking List


Thoracic aortic aneurysm stent grafts will now be tracked

Stryker Files Lawsuit Over Federal Government Inquiry


Company sparring with government over 'oppressive' subpeona

Covidien Seeks to Bulk Up Portfolio Through Venture Capital Arm


New group focused on investing in companies developing new medical devices, diagnostics and pharmaceuticals

Abbott Cutting 1,000 Jobs


Move is part of a multiyear effort to lower spending on its medical testing business

September 2, 2008

Dug/Device Makers Given Legal Shield By Rule, Lawyers Claim


Rule limits changes companies can make to product warnings

Draft Guidance Distinguishes HDEs From IDEs


HDE approval is based on safety and probable benefit

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