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August 27, 2008

FDA Approves St. Jude Medical's New Facility in Puerto Rico


Manufacturing plant will produce pacemakers and cardiac leads

Stricter Norms in India to Ensure Healthy Medical Devices


New standards are meant to test and verify medical devices

August 26, 2008

Medtronic Sues NuVasive for Patent Infringement


Lawsuit filed against NuVasive

Terumo to Expand, Gets $855,000 State Tax Credit from MI


Relocating R&D and manufacturing from California to Michigan

August 25, 2008

Stent Maker OrbusNeich To Hire up to 200 Employees


Company preparing for clinical trials

Kalamazoo Manufacturing Firm Keystone Solutions Group Expanding in Grand Rapids


Company is doubling in size

August 22, 2008

Massachusetts Governor Signs Law Making Drug Companies' Gifts to Doctors Public


Representatives of the pharmaceutical and biotech industries opposed the legislation

FDA Warns NeoChild for Misbranded Devices


Company allegedly failed to establish written procedures for numerous good manufacturing practice requirements

August 21, 2008

FDA Warns X-spine for Supplier Agreement Failures


X Spine must address 12 alleged failures

Siemens Begins Layoffs at Pennsylvania Headquarters


Layoff notices issued to 350 as part of the 16,750 job cuts announced in July

August 20, 2008

Medtronic Expands Legal Battle Over Patents


Accuses two companies of infringing a patent for a stent used in the treatment of blood vessels

Anika Therapeutics Gets Warning Letter


FDA cites company for failing to have hand-washing sink outside sterile gowning room

August 19, 2008

Boston Scientific Recalls Neck Artery Stent Products


Company cites issues with stent delivery system

Endocare Inc. Rejects HealthTronics Buyout Offer on Price


Calls $26.9 million offer 'inadequate'

August 18, 2008

Lawsuit Alleges Medical Device Makers Paid Illegal Kickbacks to Doctors


Six joint implant manufacturers accused of selling inferior and more costly products

Newspaper Suggests Flaws in Study of Boston Scientific Stent


Wall Street Journal claims company used faulty data in study of drug-coated stent

August 15, 2008

FDA Will Focus on Audit Reports During Inspections


An effective audit program must streamline auditing and assessment processes

Senators Introduce Their Version of Anti-Preemption Bill


Senate version co-sponsored by Democratic Sens. Edward Kennedy and Patrick Leahy

August 14, 2008

Datascope Sells Vascular Closure Business


Deal worth $24 million

Ethicon Endo-Surgery to Acquire California’s SurgRx


SurgRx’s EnSeal line will provide a new platform for Ethicon’s ultrasound devices

August 13, 2008

Investigation Into Burned Cornea Draws Warning Letter


Warning is related to the company's hot and cold compresses

Heart Devices Underused by Hospitals, Study Says


Fewer than half of eligible patients were implanted with medical devices for their heart

August 12, 2008

HealthTronics Makes Unsolicited Bid for Endocare


Deal worth $26.9 million

Covidien Acquires CardioDigital Inc. Technology


Technology for patient monitoring will complement an existing Covidien product

August 11, 2008

Cardinal Exploring Spinoff as Prior Sale Dampens 4Q Earnings


Company's profit tumbles 64%

Smith & Nephew Threatens to Sue Plus Bosses


S&N finds

August 8, 2008

Arbios Suspends Company Operations


Company focusing on raising funding

Cook Medical Moves to Take Lead in Esophageal-Stent Market


New line of stents entering the American and European markets this year

August 7, 2008

J&J Receives U.S. Subpoena Over Bile Duct Stent Sales


Subpoena part of broader probe affecting Abbott Laboratories and Boston Scientific

FDA Proposes Program To Boost Orthopedic Device Safety


Program would search public and private databases

August 6, 2008

Levitronix Recalls CentriMag Extracorporeal Blood Pumping System


Defective device was distributed worldwide

Veridex Sews Up Immunicon Acquisition


Immunicon filed for bankruptcy to facilitate transaction

August 4, 2008

Survey: CAPA Systems in Need of Work


Survey included responses from 221 employees in the medical device industry

SonoSite Announces Ruling in Patent Infringement Suit


Company resolves lawsuit with General Electric

August 1, 2008

Firm’s Plan to Restate Financials Prompts Suits, SEC Inquiry


ArthroCare to reissue its financial statements from 2006 through 2008

Abiomed Moving Jobs to Massachusetts


Abiomed has already added positions at its Massachusetts headquarters to handle new work

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