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December 2012

Fenwal Executive Takes on Fresenius Leadership Role Post-Acquisition


Executive will be in charge of medical device business in North America.

United States Diagnostics Standards Appoints New CEO


New hire will lead company's goal to become leading independent evaluator for industry.

St. Jude Faces Shareholder Lawsuit Over Durata Leads


The lawsuit specifically targets three top executives.

Thoratec Gains Japanese Approval for Heart Device


After U.S. recall, company revises labeling to reflect possible risks.

Monteris Appoints Board Chairman


Company is focused on upping the visibility of its neuro-oncological device.

President Against Device Tax Delay


In an interview, President Obama made it clear he opposes efforts to delay or repeal the tax.

Alere Appoints Chief Operating Officer


The company snagged DePuy Spine's departing worldwide president.

Democratic Senators Urge Tax Delay


Growing chorus of lawmakers from both parties push for a postponement.

BiO2 Medical IVC Filter Catheter Receives CE Mark


Company is pursuing gold standard technology to prevent pulmonary embolism.

Merit Medical Gets FDA OK for Endovascular Snare System


Single-loop design updates the company's three-looped device.

Flambeau Hires New Business Development Chief for Medical Unit


Company continues push to grow medical manufacturing.

Winland Electronics Names New CEO


New hire initially joined the company as an adviser to the board.

IRS Publishes Guidance on Medical Device Tax


Industry still pushes for repeal.

Urologix Names Interim CEO


As previous executive officer steps down, the search begins for a permanent replacement.

Aptiv Solutions Opens North Carolina Office


The facility consolidates Aptiv and its N.C. subsidiaries in one location.

Baxter Buys Gambro


Company gains access to wider geographic markets as well as dialysis products to add to its portfolio.

Laserage Technology Buys Majority Stake in Venta Medical


Both companies will benefit from their expanded position in the contract manufacturing marketplace.

Cretex Companies Acquires Spectralytics


Spectralytics will become part of the newly minted Cretex Medical group of companies.

Public and Private Sectors Come Together to Improve Medical Device Regulation


LifeScience Alley connects medtech companies with the FDA in a new partnership effort.

Mission Micro Molding Corporation Adds Clean Room Space


The expansion includes assembly space as well.

Resonetics Opens New Lab, Gains Patent


The new location will focus on laser technologies among other functions.

Volcano Corporation Acquires Crux Biomedical


The purchase affords Volcano access to Crux's inferior vena cava filter system.

Axogen Nerve Graft Clinical Study Yields Promising Results


Some repairs show 100 percent rate of recovery, according to journal report.

November 2012

St. Jude Assura Heart Devices Receive European Approval


Company also approves massive share buyback program.

FDA Report Outlines Plan for Improvements in Device Review


The agency moves forward with obligations set forth by recent legislation, while some remain skeptical.

Smith & Nephew Snags Healthpoint in Major Acquisition


Healthpoint will bolster S&N's wound management business.

HeartWare Gets FDA Nod for Ventricular Assist System


The system is designed to be a bridge to heart transplant.

Westhouse Medical Services Acquires Majority Stake in Quy Biosciences


A full acquisition is planned.

Cadence to Open Pittsburgh Facility


The company enters the finished device business.

Nihon Kohden Acquires Defibtech


Together the companies hope to create a robust AED business.

First St. Jude Portico Heart Valve Implanted Transapically


The device is intended to eliminate the need for bypass during heart surgery.

LeMaitre Vascular to Open Canadian Office


The company aims to expand selling and marketing capacity north of the U.S. border.

Merit Medical to Purchase Thomas Medical


A GE company, Thomas Medical is Merit's second recent acquisition.

Volcano to Close on Sync-Rx Acquisition Within a Month


Company hopes to mitigate scrutiny into PCI procedures with Sync-Rx’s technology.

Toshiba Releases New CT System


Company highlights machine's extremely thin slicing capabilities.

Medtronic Announces Second Quarter Earnings, Closes on Kanghui Acquisition


Analysts wary of the high price paid for the Chinese company.

Sanovas Receives Patent Allowance for Drug Delivery System


The system delivers localized drugs, particularly useful for chemotherapy treatment.

Tornier CEO Retires, Company Names Interim Officers


Though unexpected, departure is on good terms.

OptiMedica Secures Growth Financing for Cataract Surgery System


Money will fund commercialization and next-generation technology.

New Tool From UK's Zilico Goes After Cancer Diagnosis Market


Technology is the result of 20 years of academic research.

Around the World in 3.5 Days


Countries use innovative measures to promote their biotech/medical device sectors.

Cutting-Edge Devices Debut in Deutschland


Futuristic medical products dazzle attendees at trade show.

Fort Wayne Metals Showcases New Product at Compamed


New ACC wire builds on existing company technology.

Samsung Debuts New OB-GYN Imaging Equipment at Medica


Company moves forward with plan to be player in medical imaging market.

Stryker Names Ortho and Neuro Group Presidents


The appointments are part of a management realignment effort.

Medica Hosts First AppCircus


Winner chosen from nine mobile health applications.

Cook Medical Stent Becomes First FDA Approved for Peripheral Artery Blockages


The drug-eluting stent delivers paclitaxel to treatment sites.

Companies Charge Ahead with DEHP-Free Devices


Firms at Medica and Compamed tout preparedness on the non-DEHP front.

Final Push For Medical Device Tax Repeal Underway


Medtech industry urges lawmakers to nix innovation-killing levy.

New Test Spots Contamination on Medical Instruments


Company claims its system helps to "remove any doubt" from the decontamination process.

A. Hopf and Eastman Chemical Team for New Component Technology


New copolyester from Eastman is used for Hopf's latest line of stopcocks and Y connectors.

For Microsystems Technology, Smaller Is Always Better


As system technology evolves, possible applications become numerous and varied.

U.K. Company Debuts New Biosensor for Infectious Disease Diagnosis


Technology combines special biosensor materials with advanced electronics.

Lab-Accurate Results Without the Lab


New low cost POC analyzers make their debut at Medica.

DTR Medical Introduces New Instrument to Reduce Risk Contamination


Biopsy punch is designed to remove risk of cross contamination.

Have a Seat, Save a Life


Company releases sensor that can detect heart rate, respiration through chair cushion.

Welch Allyn Literally Takes Medica's Pulse


Firm shows off its technology in real-time to assess the collective health of show-goers.

Siemens Introduces New Ultrasound System


Latest iteration imports various features from earlier device.

Sony Unveils Bevy of New Products at Medica


Medical 3-D recorder, 3-D camera among innovation debuting at show.

Philips-Respironics Rolls Out New Ventilator for Chronic Respiratory Insufficiency Diseases


New device launched during World COPD Day.

Bal Seal Spotlights Equipment Performance Solutions at Compamed


The firm's technology is used to protect high-speed rotary drive units in medtech.

High-Performance Plastics on Tap for BASF at Compamed


Antimicrobial products are highlighted at this year's show.

DDL Hires New Quality Assurance Manager


With an increase in customer quality expectations, the company anticipates growth.

Medica 2012 Underway in Germany


Organizers expect more than 4,500 exhibitors from 64 countries to attend event.

Eldon James Highlights Antimicrobial Products at Compamed


Company is broadening its reach in European markets.

New Microscopy Technology Showcased at Medica


Company is billing new device as iPad of microscopy.

Steris Acquires Two Surgical Device Repair Companies


The buy strengthens Steris' position in what is currently a fragmented market.

Medical Murray Opens New Design and Development Facility


The location is expected to be fully operational by March.

Saint Gobain Plastics' Healthcare Unit Releases New Tubing for European Market


Launch made during Compamed trade fair in Germany.

Avery Dennison's Medical Unit Revamps its Brand


New name reflects move beyond simple healthcare adhesives.

Becoming a Trade Show Pro


A PR executive shares tips about how to harness the unique benefits of B-to-B trade shows.

Filtrona Porous Technologies Highlights New Tech at Compamed


Molded and thermo-formable, medical-grade foams among products featured.

Medica & Compamed Chief Talks About This Year's Installments


Annual trade fairs in Germany attract global audience.

UL Acquires Third Health Conformance Company


UL will fold Wiklund Research & Design into its life and health business.

FDA Approves New Use for Edwards Lifesciences Heart Valve


The Sapien valve can now be inserted through the ribcage.

Helix Medical Expands with MedVenture Acquisiton


Helix gains footholds in key U.S. medtech clusters.

Nanosphere Adds Former JNJ Executive to Board


After three successful fiscal quarters, CEO hopes new addition will help maintain continued performance.

Cretex Collects its Medical Companies Under One Brand Umbrella


The result is the newly named Cretex Medical.

ConforMIS Relocates Headquarters


The new space is four times the size of the old location.

Phillips-Medisize Completes Czech Expansion


The facility provides services to European and North American customers.

Weak Rupee Could Spawn Higher Device Prices


India's currency has lost more than a quarter of its value since the summer of 2011.

Carestream Gains Clearance for Lesion Management Module


The module can be used with most picture archiving and communication systems.

Medtronic CEO Stresses the Importance of Value Propositions


Omar Ishrak spoke to an audience at Cleveland Clinic's Medical Innovations Summit 2012.

Regulatory Update: New FDA Requirements for Contract Manufacturers


Consultant provides a basic primer for new medical device establishment registrations.

October 2012

CR Bard Buys Neonatal Device Company Neomed


Neomed will be added to Bard company Davol.

Heraeus Opens New Facility in Singapore


The facility will be dedicated to medical device materials, components and R&D.

Patent Lineup: Recent Noteworthy Medtech Patents


Innovation depends on protecting intellectual property.

Smiths Medical Gains CE Mark for Safety Catheter


The device is designed to reduce accidental needlesticks.

CEO Kevin Lobo Provides Glance into Stryker's Future at Cleveland Clinic's Medical Innovation Summit


Lobo plans to focus on efficacy rather than product innovation.

InspireMD Stent Shows Promising Trial Results


Approved in the E.U. already, the trial is one more step toward U.S. approval.

Medtronic Under Microscope Following Senate Report


Senate findings suggest Medtronic manipulated Infuse bone graft data.

Infraredx and Philips Join Imaging Capabilities


Venture intended to help physicians better control vascular images.

Study Shows Reused ICDs Can Be Successful


FDA not supportive of reused cardiac devices in the United States.

Cadence Names CEO, Announces Share Repurchase Plan


Repurchase plan is Cadence's vote of confidence in its own future.

Stentys Starts U.S. Cardiac Device Trial


Stent has enjoyed success in Europe.

Vascular Solutions' Hemostasis Device Launched in U.S.


Company distributes device for Chinese firm Lepu Medical Technology.

Utah Claims Lead in Medical Manufacturing Concentration


The Beehive State shows significant medical device growth.

Drug Coated Balloon Test has Promising Results


Vascular Nanotransfer Technologies looks to create "gold standard" technology.

Medical Device Panel Reports Rising Malware in Hospital Equipment


Experts met at the National Institute of Standards and Technology to discuss the issue and what steps should be taken.

Massachusetts Attracts Microarray Company from United Kingdom


Gov. Patrick continues push for medtech in the Bay State.

Helix Medical Completes MedVenture Technology Acquisition


The purchase strengthens Helix's product life cycle management.

St. Jude Expects Warning Letter From FDA


CEO would not cite specifics, but disclosed the expectation in the interest of transparency.

Stryker Strikes Deal to Buy Neurotechnology Company


This is a natural move for Stryker, which continues to bolster its stake in the fast-growing neuro market.

Cardiologists Say Stents are Overused in China


The problem has been seen before in the west, possibly because stent procedures are so profitable.

Medtronic Makes Second China Acquisition


The announcement comes less than a month after another purchase.

Fresenius Off the Hook for Million-Dollar Lawsuit


Judge rules company does not have to pay $82.6 million previously ordered.

Accuray Appoints New CEO


Former CEO leaves after a decade.

AspenBio Proposes Name Change


Company rebranding itself to highlight blood-based test.

St. Jude Battling Supplier Over Durata Lead Insulation


AorTech accuses St. Jude of an unspecified contract breach.

Three-Year Data From Paclitaxel-Eluting Stent Trial Now Available


Cook Medical's Zilver PTX stent not yet available in the United States.

Thoratec Names New CFO


Company under the guidance of an interim CFO since last year.

Major Restructuring at Quest Will Cost up to 600 Jobs


Company joins Stryker, Medtronic, and others in downsizing.

BD Loses CFO, Begins Search for Replacement


Interim CFO has been appointed in the meantime.

FDA Calls for "Spying" Case to be Thrown Out


The agency cites improper procedures by the plaintiffs.

Boston Scientific and UofM Collaborate on Research Grants


The program tackles IP resulting from industry funding.

ITW Medical Products Completes Coeur Buyout


The addition of Coeur will expand ITW's product line.

AngioDynamics Inks Deal to Purchase Vortex Medical


Vortex's products will be folded into AndioDynamics' peripheral vascular portfolio.

Boston Scientific to Acquire Rhythmia Medical


The medical device giant seeks to expand in the electrophysiology market.

Sunshine Heart Moves Forward with Heart Failure Device Trials


The company received an IDE from the FDA for the device.

"Bionic Eye" Receives Nod from FDA Advisory Panel


Second Sight's device treats retinitis pigmentosa, a rare disease that can cause blindness.

Diagnostics Organizations Join to Produce Series of Reports


The reports will provide basic information on current diagnostics innovation.

Bjorksten/Bit 7 and Granite MEDSystems Form Joint Venture


The companies hope to streamline their capabilities for clients.

The Hackable Body: How Severe is the Threat?


AdvaMed panel provides insight on the issue.

Dassault Launches Device Data Management Solution


"Licensed to Cure" enables companies to master relationships between product innovation, quality assurance and regulatory compliance.

Phillips-Medisize to Expand to Accommodate Cold Chain Storage


Predicted completion of expansion is April 2013.

Medtech Industry Faring Well in Tough Global Economy


Latest Ernst & Young report indicates solid performance in 2011.

Sunshine Act Compliance: An Elusive, Confusing Task in the United States and France


AdvaMed panel stressed communication and preparation as key to navigating compliance requirements.

Argo Calls Massachusetts Home, Shows Cutting-Edge Tech (VIDEO)


At AdvaMed 2012, paralyzed patient walks aided by company's mobility system.

Interoperability and User-Friendliness Key to the Future of Health IT


The health IT panel at AdvaMed 2012 featured medtech representatives and patient advocates.

Endologix Appoints New VP of Clinical Affairs


New hire is an expert in regulatory affairs and compliance.

Clemson University Establishes Engineering Program for Recyclable Medical Device Design


The program is the first of its kind in the United States.

Avery Dennison’s Transparent Film Dressing Cleared by FDA


The anticipated U.S. release is fall 2013.

AdvaMed’s Election Special: Pundits and Predictions


Speakers at the device association’s annual conference examine this year’s presidential contest.

September 2012

Medtronic to Buy Orthopedic Device Company Kanghui


CEO says the acquisition is part of Medtronic's goal of globalization.

Clearbridge Biomedics partners with Cambridge Consultants on Liquid Biopsy Device


The device is the next-generation version of Clearbridge's ClearCell System.

FDA Clears Guide Wire from Merit


The agency's OK comes following a warning letter earlier in the year.

Utah Appoints Director of State Life Sciences Cluster


The newly created position is meant to drive the development of Utah's life sciences sector.

NAMSA Opens Office in China


The new location will provide a nexus for China and other regional clients.

Boston Scientific Acquiring BridgePoint Medical


The medical device giant is adding BridgePoint to its Interventional Cardiology Division.

Cyberonics Agrees to Invest in Cerbomed


The two companies are focused on the treatment of epilepsy.

E.U. Approves Extended Indications for Sorin Group's Cardiac Device


Device now can be used in patients 65 and older.

Huron Life Sciences Gains Managing Director


The new hire will focus heavily on R&D for pharmaceutical and medical device customers.

MEDICA and COMPAMED 2012: Joachim Schaefer Provides Insight Into This Year's Installment


The trade fairs in Germany provide a forum for players from all corners of the medical technology industry to come together.

BD Introduces Nano Needle Technology to Improve Injection Comfort


The needles are targeted toward diabetes patients who fear needles due to pain or discomfort.

FDA Approves Ultrasound Companion to Mammograms


The system is geared toward women with dense breast tissue.

NuvoLase Receives ISO Certification


The company manufactures podiatric devices.

Covidien Offers New Devices for CTO Treatment


The devices are available in both the U.S. and the E.U.

Danaher to Acquire Iris International


Iris will join Danaher's Beckman Coulter diagnostics business.

CareFusion Further Delays Filing Annual Report


Latest delay could cost the company NYSE listing.

Two Organizations Join to Set Standards for Medical Device Interoperability


Officials claim the space of interoperability needs to be developed.

Teleflex Medical OEM Completes Expansion


The New Hampshire facility is hoped to provide 25 new jobs.

Lawmakers Continue to Criticize Device Tax in the Run Up to Election


Rep. Paulsen and industry advocates believe government is unprepared for the implementation of the tax.

Helix Medical Opens Costa Rica Plant


The facility is the company’s first in Latin America.

China Clears Varian Cancer Treatment System


The system is relatively affordable, a big attraction for emerging markets.

Ximedica Appoints New Board Member


New hire brings experience in product innovation.

Welch Allyn Announces Job Cuts, Restructuring Plans


Citing the medical device excise tax, the company looks outside the United States for new business opportunities.

Report Suggests Refurbished Device Market Will be Worth $8.45 billion by 2017


Research company details how the market share is divided globally.

Abiomed Updates Heart Pump


The new version of the Impella is doubly powerful, company claims.

AppCircus Selects First Four Winners to Compete At Medical Trade Fair


Entries may still be submitted until the end of October.

Global Data Suggests Endovascular Stapler System Needs More Work


Researchers believe Intact Vascular’s new technology will not best existing technology.

Two New Uses Approved for Boston Scientific Spine Stimulator


The CE Mark approves the system to treat chronic pain and patients who need MRIs.

CDRH Releases Report on Medical Device Postmarket Surveillance


This report is part of a slew of steps the FDA is taking to keep the promises of MDUFA.

Endologix Gains CE Mark for Abdominal Aortic Aneurysm Treatment


The device is being updated, and the new version will be re-submitted for approval.

OptiMedica Gets FDA Clearance for Cataract Surgery System


The device received European approval earlier this year.

ZeroTo510 Startup Receives Venture Capital Funding


Restore Medical Solutions was one of the first companies to participate in the accelerated device development program.

KCI Introduces Mattress Cover to Reduce Pressure Ulcers


The cover is intended specifically for obese patients.

Teleflex Expands Arrow Line to Include Spinal Anesthesia Kits


The news comes soon after the release of a new Arrow catheter earlier this month.

Surefire Releases Infusion System in Europe


The company received the CE Mark a year after it received FDA clearance.

Michigan State University Spinoff Receives Series A Funding


The investment will go toward the development of a blood flow monitoring device.

San Diego Manufacturer Completes Expansion


Specialty Manufacturing’s expansion more than doubles its plant size.

Cook Medical Opens New Facility in Illinois


The new Canton location will manufacture polymer tubing.

West and Janssen Biotech Collaborate on Injection Technology


The two companies will join forces on a self-injection drug delivery system.

ISO in the Works for Joining Technologies


The company hopes to be one of the few welding companies to achieve the medical device ISO standard.

August 2012

St. Jude Reorganizes, Sheds 300 Jobs


The company consolidates product divisions and shuffles its executive leadership.

AngioDynamics to Release Catheter with New Polymer Technology


The company has received FDA clearance for the device.

Elixir Medical Receives European Approval for Coronary Stent System


Company says trial results best Medtronic’s Endeavor stent.

Hospira Warned About Infusion Pump Problems


The company’s Costa Rica plant is under scrutiny by the FDA.

China Invests in UK Biotech Startup


The investment is in line with China’s current focus on biotechnology.

Boston Scientific Cardiac Device Gets Expanded Indication in Europe


The company is beginning the process to release the device in the United States.

Becton Dickinson Acquires Sirigen


Sirigen is a Nobel Prize winning polymer technology company.

Getinge Group Purchases Part of Kinetic Concepts Inc.


Getinge hopes to bring the Therapeutic Support Systems business to its European markets.

Symmetry Medical Receives Clearance for Valve


The valve is a new version of the company’s older sterilization product.

Jarvik Heart Gets Green Light for Cardiac Device Trial


The company hopes to establish Jarvik device’s superiority to others on the market.

Siemens to Acquire Penrith


Siemens will bolster its ultrasound business with the purchase.

New Research Shows Cardiac Sector Will Grow Very Little


Millennium Research Group cites market saturation for the sluggish growth prediction.

Zoll Medical and Inovise Medical Pair to Improve Cardiac Device


Zoll’s wearable defibrillator will now benefit from Inovise’s acoustic cardiography technology.

Gore Gains CE Mark for Vascular Graft


The graft is designed to facilitate sutureless anastomosis, among other applications.

Toshiba Medical Appoints Director of CT Unit


The new hire joins Toshiba from Philips Healthcare.

Israeli Company Ornim Receives Series B Funding


GE and Orbimed join to invest in the oxygen monitoring device company.

Codman & Shurtleff Releases New Microcoil Technology


The new two new microcoil systems are available in the United States and Europe.

Helix Medical to Invest in Cambus Medical


Helix will acquire half of all company shares by next year.

Luminex Enters Contract with Department of Defense


The company will develop a biothreat detection instrument.

FDA Proposes Criteria for Determining Completeness of 510(k) Submissions


The agency hopes to further speed up review times with this guidance.

Sound Interventions Discloses Early Data from Hypertension Trial


The results are good: The company can replicate lowered blood pressure both in office and over 24-hour monitoring.

MediPurpose Releases Updated Baby Heel Stick


The lancet comes in sizes for newborns and preemies.

Varian Medical Loses CEO, Gains Board Members


The company promotes COO to CEO position.

Resonetics Appoints New CEO


CEO has experience in both medical devices and contract manufacturing.

Teleflex to Acquire LMA and Its Brand of Laryngeal Masks


The purchase will beef up Teleflex’s anesthesia business.

Codman & Shurtleff Drug Delivery System Gains FDA Approval


The system delivers baclofen for the treatment of spasticity.

FDA Approves New Stent System from Abbott


The device is intended to treat iliac artery disease.

Masimo Adds to Patient Monitoring Business with Phasein Purchase


The acquisition prompts a revision of Masimo’s financial predictions for 2012.

Teleflex Medical OEM Gains Patent for Suture


The suture has been in use since 2004.

Qforma Names New VP of Business Development


New hire brings 15 years experience in sales and marketing.

iRhythm Appoints New President and CEO


Kevin King replaces Bill Willis on the board.

China Regulatory Officials Now Can Perform Unannounced Inspections on Device Manufacturers


The SFDA announced the new procedure on June 18.

Vascular Solutions Releases Flexible Tip Microcatheter


The device is a new addition to the SuperCross product line.

Covidien Receives FDA Clearance for Bedside Monitoring System


The system is designed to help physicians monitor oxygen levels more quickly.

Saint-Gobain to Phase Out Use of DEHP


Studies show elevated exposure could have emasculating effects on male patients.

Teleflex Subsidiary Gets CE Mark for Catheter Device


Semprus BioSciences division gains EU clearance for catheter technology.

Sanmina Achieves Yet Another ISO Certification


The company’s Mexico facility has been awarded an ISO 13485 certification.

July 2012

Proteus Digital Health Receives Clearance for Ingestible Sensor


The device can be integrated with drugs and pharmaceuticals.

OncoSec Medical Achieves ISO Certification


The company has been awarded the ISO 13485 certification for electroporation devices.

Medifocus Buys Prolieve Back from Boston Scientific


The device treats benign prostatic hyperplasia.

Becker & Associates Consulting Acquired By NSF International


NSF's list of services will be complemented by what Becker & Associates brings to the table.

University of Minnesota Gets Million Dollar Grant


The money will fund an expansion of the university’s Medical Devices Center.

Histogenics and ImageIQ Partner for Clinical Trial


ImageIQ will provide imaging analytics to Histogenics.

Fresenius Buys Fenwal in Billion-Dollar Deal


Fresenius insists it still has buying power for a takeover of Rhoen-Klinikum.

Illumina Forms New Reagent Portfolio


The company highlights the cost effectiveness of its new products.

Secant Medical Receives Award for Implantable Textiles


The Frost & Sullivan Award recognizes innovation among other achievements.

BMS Introduces New Weaving Technique for Artificial Tendons and Ligaments


CEO says company will be able to match human tissue closer than ever before.

NAMSA Continues Growth with Integra Group Acquisition


The companies hope to get medical devices to market sooner by joining forces.

Fresenius Faces Recall Investigation


The company is questioned for a possible delay in public disclosure.

STERIS to Acquire US Endoscopy


STERIS CEO dubs the deal the company’s “most significant” in a long time.

Tecomet to Acquire Teleflex’s Orthopedics Business


The deal is anticipated to close by the third quarter of 2012.

FDA Document Leak Reveals Agency “Spies” on Employees


Senator puts pressure on FDA to explain itself.

TIDI Products Acquired by Private Equity Company


New owner pledges growth.

Medical Main Street Spotlights Medtech in Michigan


The conference will focus on local companies and connect industry players.

Becton Dickinson to Acquire Safety Syringes


BD will gain a line of anti-needlestick devices.

Greatbatch Opens Facility in Singapore


The new R&D center will focus on the cardiovascular and neuromodulation markets.

Medica Searches for Innovative Health Apps


Winning Apps will present at Medica 2012.

Massachusetts Makes Significant Changes to Gift Ban Law


The amendments have supporters and dissidents from all sides.

MiCardia Announces New Funding and Spin-off Company


Internal funding will go toward an annuplasty device, while external funds fuel spin-off.

Luminex Agrees to Acquire GenturaDx


News of the deal has caused dismay among investors.

OxySure Ventures Into Brazil


The respiratory device company will introduce a new product to the Brazilian market.

President Obama Signs FDA Bill into Law


The bill’s approval has been praised for its rare bipartisan effort.

CVRx Creates Chief Commercial Officer Position


The company attracts Medtronic executive to fill the role.

Cook Medical Receives FDA Clearance for Colonic Stent


The stent joins the company’s Evolution line of stents.

EU Approves Brainsway Device for Chronic Pain Application


The neurological device is already approved to treat a number of other disorders.

FDA to Release Plan for Device Identification System


Device identification is mandated by the recently passed user fee legislation.

FDA Clears ProPep Nerve Monitoring System


The system will be used in prostatectomies.

Synergetics Retinal Surgery Devices Received FDA Clearance


The device is under review for the CE Mark.

June 2012

U.S. Supreme Court Votes to Uphold Universal Healthcare


The most controversial aspect of the bill, the individual mandate, was also upheld.

Dune Medical Devices Gains FDA Nod For Breast Cancer Surgical Device


The device is designed to help surgeons identify all cancerous tissue during lumpectomies.

FDA User Fee Act Passes Congress, Awaits President’s Approval


The passage of the legislation praised as a rare example of bipartisan American politics.

Symmetry Medical Expands Micro Instruments Line


The line will be introducued via subsidiary Symmetry Surgical

St. Jude Medical Fights Accusations of Further Lead Failures


The Durata lead is now under fire, but the company claims the lead failure was caused by external factors.

Greatbatch Medical Opens Manufacturing Center in Midwest


New facility is just a few miles from the company’s orthopedic design location in Warsaw, Ind.

Medtronic Cardio Device is One of Nine Selected by FDA for Accelerated Review


The Valiant Mona LSA System treats descending thoracic aortic aneurysms

Microline Appoints New CFO


Darlene Deptula-Hicks has a strong background in medical device finance.

Covidien Unveils Proprietary Knotless Suture Device


The V-Loc now can be paired with the company’s other suturing devices.

Velcro Medical Division Introduces Anti-Bacterial Fasteners and Catheter Patches


The company developed the products under advisement from a panel of nursing professionals.

Boston Scientific Snags JNJ Executive


The company taps former JNJ bigwig to head up its Chinese operations.

Precision Engineered Products Open Facility in Caribbean


The Dominican Republic manufacturing plant is producing surgical staples but will expand soon.

Omniguide Names New CTO


New hire most recently was a Covidien executive.

The Medical Device Tax: Sound Bites From Across the Nation


Viewpoints and progress on repealing the medical device excise tax.

Sigma Pump Recall Expanded by the FDA


Pumps manufactured after November 2010 are exempt.

FDA Clears St. Jude Vascular Plug


The Amplatzer vascular plug offers an alternative to traditional embolic coils.

Philips Opens Facility in India


The manufacturing facility will cater specifically to the Indian market, but has the flexibility to expand for other global markets as well.

BioVentrix Appoints Two New Board Members


Fazio and Healy bring extensive cardiac experience to the table.

Women’s Sexual Health Device Gets Go-Ahead from Canada


Viveve to introduce a device for women post-childbirth.

Where are all the AEDs?


Study finds defibrillators are located too far away from victims.

GAO Submits Report on IMD Use


Rate of use has generally increased, especially for orthopedics.

Former CEO Receives Probation for Lying to Feds


John Schulte is sentenced to 12 months of probation, fined $5,000.

Johnson & Johnson Completes Synthes Acquisition


With some slick maneuvers, the company also manages to minimize its U.S. tax hit.

DSM Buys Kensey Nash for $360M


Deal is expected to close by June 30.

Nonin Medical Introduces Pediatric Oxygen Monitoring Device to U.S. Market


Equanox measures oxygen saturation in both brain and body tissue.

CareFusion Acquires U.K. Medical, Expands Presence in Europe


The company has been strategically buying and selling with plans to establish presence in key global markets.

Aptiv Solutions Achieves Quality ISO


The company voluntarily decided to achieve certification to assure clients it has quality standards in place.

Consort Medical Shuts Down Sheffield Plant


The move is unexpected, as the company only purchased the plant three years ago.

Nicole Wicker Appointed CFO of TearScience


The young company has Wicker to thank for significant funding it received for its dry eye devices.

Apollo Endosurgery Attracts Retired Covidien CEO to Board


Richard Meelia occupies a newly created seat on the board of directors.

Maquet Expands Size Offering of IAB Catheters


Sizes will benefit taller, larger patients.

Bruker Appoints New CFO


William Knight steps down as Charles Wagner takes his place.

Device Tax Repeal Passes in the House


Tension rises as the medtech industry inches closer to its goal of a total repeal of the tax.

New CEO Barry Starkman Takes the Wheel at HemCon


As the company recovers from bankruptcy, Starkman has a particular set of challenges ahead.

House to Vote on Device Tax Repeal Today


Similar measure would be unlikely to pass in the Senate.

Next Generation Teleflex Epidural Catheter Receives FDA Clearance


The new catheter features multiple ports, whereas the previous version had only one.

Alliqua Continues to Beef Up its Scientific Advisory Board


The company appoints new members, accessing expertise to help its products on the market.

Medtronic Launches Stent Graft System in U.S.


The system treats abdominal aortic aneurysms, and has been available in Europe since December.

GE Healthcare Completes Acquisition of XPRO


The company continues to show active interest in growing its South American presence.

Terumo BCT Invests in Vietnam Plant


The company also will invest in a new U.S. facility.

Representatives Paulsen and Altmire Address MDMA


The congressmen represent the bipartisan support the device tax repeal has garnered.

MDMA Election Panel Discusses Medical Device Industry Strategy


Kevin Madden and Karen Finney use their expertise in political strategy to advise MDMA members how to move forward.

May 2012

House Approves FDA User Fee Reauthorization


Legislation is similar to Senate bill that passed last week.

Health Robotics Signs New Distribution Deal in Saudi Arabia


The company sets its sights on global expansion.

Medtronic Presents Data from Drug-Eluting Stent Clinical Trial


The Resolute DES is being studied for its effectiveness in patients with both coronary heart disease and diabetes.

Fanem Debuts Hybrid Product at Hospitalar


Incubator doubles as an infant warmer.

GE Unveils New Products at Hospitalar


Company simulates hospital setting to introduce and showcase devices.

Line of Airway Devices Receives FDA Clearance


ETView will begin marketing the devices in the United States immediately.

Flowonix Receives a Further $25 Million in Capital


The financing will fund next-generation drug-delivery products.

House Republicans to Push Medical Device Tax Repeal Bill After Memorial Day; Meanwhile, FDA User Fee Reauthorization Passes Senate


Efforts continue to repeal the 2.3 percent device excise tax set to come to fruition next year.

BD Elects Company Veteran as Chairman


CEO Vincent A. Forlenza will take on his new responsibilities in July.

Second Life Biomedical Expands Beyond Original Intended Reach


The subsidiary of Dixie Medical provides medical equipment repair services.

Medtronic Foundation Continues to Fight NCDs Globally


The foundation has granted almost half a million dollars to Partners in Health to work against NCDs in Rwanda.

Sizewise Launches “Intuitive” Acute Care Bed


The Navigator was designed by clinicians, and comes with a range of features.

Covidien Appoints New Treasurer


Gregory Andrulonis is a long-time employee of the firm.

Aerocrine Receives Australian Approval for Airway Inflammation Monitors


This is a step toward reimbursement for the devices.

Hospitalar 2012 by the Numbers


A statistical snapshot of Latin America's largest healthcare conference.

Healthcare Professionals Converge in Brazil for Hospitalar 2012


Organizers add Digital Health segment to event to address growing mobile health market.

Greatbatch Moves Headquarters


Frisco, Texas, has a lot to offer the growing company.

IsoRay Introduces Radiation Therapy System in Europe


The company intends for the system to be used with Cesium-131, which it exclusively manufactures.

AngioDynamics Appoints Navilyst Executive as CTO


George Bourne joins AngioDynamics after its acquisition of Navilyst.

Agilent to Acquire Dako


Valued at $2.2 billion, the deal is expected to close within two months.

FDA Clears Covalon’s IV Silicone Adhesive


IV Clear uses a more skin-friendly silicone adhesive along with gold-standard antimicrobial agents.

IMDS Refinances Debt, Makes Changes to Board


The company refinances senior and subordinated debt obligations and appoints new chairman of the board.

Covidien Adds New Ablation Catheter to Halo Line


The device has the potential to improve the treatment of Barrett’s esophagus.

Xavant Technology Announces a New Nerve Stimulator


The device is designed to monitor neuromuscular blocking agents, but has other uses as well.

The FCC Will Dedicate Spectrum Solely for the Use of Wireless Medical Devices


An idea two years in the making, the United States will be the first country to do so.

Devon Medical Products Signs China Distributor


PKU hopes to benefit from Devon sending more companies their way.

New Reports Highlight Medical Device Recall Trends


GBI and Stericycle present data.

Preliminary Data Available for FAME II FFR Trial


St. Jude will release further data later this year.

St. Jude Medical Launches Renal Denervation System in Europe


The system uses ablation technology to reduce blood pressure.

MDMA Letter to IRS Restates Position on Device Tax


Industry players aren't easing off on the pressure to repeal the tax.

Oakworks Appoints New Director of Business Development


Joe D'Antonio brings years of sales experience with him.

Boston Scientific Launches Stent System in Europe


The stent is used to treat peripheral vascular lesions in arteries above the knee.

Boston Scientific Allies with Philips Healthcare to Bolster Imaging Equipment Offering


The companies look forward to an "ongoing relationship."

Johnson & Johnson Makes First Device Co. Purchase in China


After doing business in the country for 25 years, JNJ has purchased Bioseal Biotech.

SRS Medical Appoints New CEO


Lee Brody will be focusing on company's new product.

Medtronic to Cut 220 Jobs from CRM Division


As yet unknown what type of jobs they will be.

Covidien Completes Acquisition of Newport Medical


The deal is valued at $108 million.

Toshiba America Medical Systems Appoints New VP of Business Operations


Calum Cunningham has been with the company for three years.

CardioKinetix Nabs Former Stryker Executive as New CEO


Maria Sainz comes with an impressive resume.

FDA Clears Toshiba CT System


Toshiba expands its Aquilion line.

Haemonetics Expands in the Blood Management Sector


The company has announced it will acquire Hemerus Medical.

Stryker Establishes Environmental Initiative Coalition


Seventeen companies commit to reducing waste and preserving the environment.

Covidien Announces Acquisition of PolyTouch


The company continues its trail of Israeli acquisitions.

Updated: Direct Flow Medical Names New CMO


Charles Davidson's relationship with the company goes back three years.

Hologic to Acquire Gen-Probe


After a year, Gen-Probe finds a buyer.

April 2012

Atrium Medical to Move Head Offices


Hudson headquarters not spacious enough.

Beckman Coulter Acquires Blue Ocean Medical


Purchase will expand the company's cytometry business.

Researchers Behind Wearable Firewall Talk to MPO


The anti-hacking device is still in its beginning stages.

Okay Industries Celebrates 100th Anniversary with Global Expansion


Company adds to manufacturing footprint in the United States and opens new facility in Costa Rica.

Singapore Decreases Medical Device Approval Time


The HSA revises its brand new device registration rules.

Business as Usual at St. Jude Medical


First quarter analysis shows earning are up slightly from last year.

EU Approves Synthes Acquisition


JNJ expects the merger to be complete in Q2.

New AdvaMed Chairman Outlines Group's Agenda


David Dvorak discusses association's three-year advocacy plan.

Stem Cell Startup Receives Funding


SynGen gets $5 million to fuel stem cell harvesting devices.

Zeltiq: First Quarter Financials, a Resignation, and Success in Court


CEO steps down as the company moves ahead in the weight loss sector.

St. Jude Medical Implants First MRI-Friendly Pacemaker in Trial


The company progresses in the heart sector despite recent lead wire controversy.

Court Claims Arizona Man Cannot File Suit Against Medtronic


Complexities of law and the wording of his claim prohibit paraplegic Richard Stengel from suing.

Aerocrine Appoints new Head of U.S. Operations


Kenneth Marshall joins Aerocrine from Ikaria.

Intravenous Catheter System Awaits FDA Clearance


Nurses anticipated to benefit from the system's ease of use.

NeuroLogica and Stryker Partner for a New Medical Imaging Product


The surgical navigation system will pair with Neurologica's BodyTom CT scanner

Forging on Amid Controversy, St. Jude Introduces ICD in Europe


The Ellipse ICD receives CE Mark approval.

Medtronic Launches Spinal Surgery System


The company claims Powerease reduces fatigue in surgeons.

Hackable Medical Devices – Is There a Solution?


The ISPAB warns about danger, while researchers get closer to preventing the problem.

TriVascular Appoints New CEO


Cofounder steps down from the post after fourteen years.

Medtronic’s Drug-Eluting Balloon Trial is Underway


The study will take place in 55 U.S. cities, and is already underway in Europe.

InVivo Spinal Device Study Expected to Commence This Year


The biopolymer scaffolding device is hoped to be the first effective treatment for spine-related paralysis.

FDA Recommends Approval of Ultrasound Cancer Screening System


The system should detect cancer better and earlier, company claims.

Philips Loses Key Executive to Quest


In another shuffle, Philips faces some challenges in the face of a drop in demand for its healthcare products.

Asante Appoints Two New Executives


Thrower and Steuben bring experience from other industry leaders.

Cardinal Health Hires Former JNJ Executive


Donald Casey will assume his post on April 16th.

Boston Scientific Launches a Steerable Sheath in the U.S.


The sheath will be used to position catheters within the heart.

Arteriocyte Partners with U.S. Military for New Stem Cell Technology


Wounded warriors look ahead to possible improved rates of limb salvaging.

Devon Medical Receives Clearance for Wound Care Device


The device utilizes suction pressure to accelerate healing.

FDA Grants Expanded Approval for Medtronic Defibrillator


The CRT-D devices will puportedly reduce mortality rates in early-stage heart failure risk patients.

St. Jude Medical Calls for Retraction of Riata Study


Accusations fly as the company struggles against bad PR and falling share prices.

Value Plastics Expands Presence in Oceania


Local customers will enjoy easier access to company products.

FDA Accepts Three Companies for Fast-Track Approval Process


All three devices treat end stage renal disease.

Boston Scientific Launches Pacemaker Series in Europe


The FDA currently is reviewing the devices for the U.S. market.

Ximedica Appoints New CEO


Randall Barko comes with 30 years experience in the business.

Covidien Agrees to Buy Israeli Company Oridion


The acquisition will bring breathing-assistance devices to Covidien.

St. Jude Medical Issues Lead Wire Advisory Letter


Though not a recall, the letter warns physicians to be vigilant in their monitoring of affected implanted cardio devices.

FDA Recalls Thoratec’s Left Ventricular Assist System


Thoratec claims it is more of a correction than a recall.

First Test in Human for Abiomed's Ventricular Assist Device


85 year old patient experienced chest pain relief.

GAO Report Evaluating FDA Performance Released


The report finds increased review times.

Biomet Agrees to Purchase Division of DePuy Orthopaedics


Move comes amidst Johnson and Johnson's negotiation with European antitrust authorities.

HeartWare Set to Acquire World Heart


Merger expected to be finalized within three months.

Medtronic Settles Infuse Lawsuit for $85 Million


Company denies any wrongdoing.

Boston Scientific Issues New Device For Urinary Stone Removal


The combination product is made up of a gel that works together with a catheter.

Derma Sciences Acquires MedEfficiency


Acquisition valued at $14.5 million.

March 2012

Globus Medical Plans to Go Public


The company doesn't specify how much it hopes to sell for at the IPO.

Covidien Announces New Endomechanical Positioning System


The system will be used to position mesh over hernias.

Oxford Immunotec Appoints New CFO


Richard Altieri is a veteran of the medical device financial arena.

Smiths Medical Glucose Monitoring System Recalled


CoZmonitor system no longer has any compatible testing strips on the market.

Endologix Chairman to Retire


Will be replaced by current CEO, John McDermott.

Bookwalter Retraction System Receives Enhancements


Symmetry's acquired technology gets a new look.

Study Claims Faulty St. Jude Defibrillator Leads Caused 22 Deaths


Company says death count is less than study shows.

New Report Adds Fuel to the Device Tax Fire


Data continues to focus on effects to R&D and jobs.

Argon Medical Adds New Chronic Hemodialysis Catheter to its Lineup


Cathether system is designed for long-term vascular access.

AngioDynamics Partners with Microsulis


Agreement broadens markets for both firms, gives AngioDynamics first shot at purchase.

Symmetry Medical Updates Bookwalter Retraction System


Technology was acquired through Codman & Shurtleff purchase.

FDA OKs Enhancements to St. Jude’s PressureWire System


Guidewire system helps to determine severity of artery blockage.

Biomet Reaches Settlement Agreement for Bribery Charges


Penalty includes DPA and fine.

Endicott Interconnect Hires CFO


New exec brings experience in high-tech manufacturing.

Oberg Medical Expands Costa Rica Operations


Plans call for doubling existing manufacturing space.

Sanofi Buys Massachusetts-Based Device Firm


Pluromed will become part of Sanofi Biosurgery.

Covidien Shells Out $300M for Israeli Pulmponary Device Firm


The price tag was 10 times the acquisition target's annual sales.

User Fee Deal Clears Next Step


The OMB gives the pact its OK.

Senators Propose UDI Legislation


Lawmakers want a law to ensure that medical devices are easy to track.

Consumer Group Battling Approval of Brain Stent


Public Citizen claims risks of product outweigh its benefits.

NAMSA Expands its European Reach


Firm opens new office in Germany.

GCMI Adds Key Executive Posts


Organization is positioning itself prior to April launch date.

AdvaMed Appoints New Board Chairman


Zimmer's CEO replaces head of Abbott Medical Optics

Span-America Buys Medical Bed Frame Manufacturer


The $8 million deal is expected to be accretive to Span-America's fiscal 2012 earnings.

Teleflex Replaces its CFO


Company has been aggressively growing its medical device business.

Japanese Firm Buys Zoll Medical for $2.2 Billion


Deal is expected to close in the second quarter.

Zimmer Moving Part of its Operations to Memphis


The transfer will eliminate jobs but executives are not providing specific numbers just yet.

Masimo Acquires One of its Vendors


New semiconductor division created as a result of purchase.

Greatbatch Appoints New CFO and CTO


New structure better positions company to seize opportunities for medtech growth, leadership says.

Boston Scientific to Acquire Cameron Health


Company hopes to breathe new life into its CRM business.

Pathfinder Technology Hires Medtronic Exec as CEO


Firm makes devices used in liver surgery.

Covidien Revascularization Device Receives FDA Clearance


Company says significant clinical trial results aided product's regulatory OK.

Hawkins to Head New Public-Private Regulatory Partnership


New Minnesota-based group combines industry, government and academia.

Boston Scientific Launches Promus Stent in Japan


System now approved in all major markets worldwide.

FDA Reaches Settlement with Medical Device Firm


Company, CEO pay penalties for distributing unapproved medical devices.

Edwards Responds to Recent CMS Proposed NCD


CMS is expected to issue its final NCD within approximately 60 days.

Varian Medical Buys InfiMed


Acquisition supplies hardware and software for X-ray workstations.

Medtronic Reports Encouraging Findings from its ASPIRE Trial


Company hopes to have its Low Glucose Suspend feature approved with its Paradigm system for use in the United States.

February 2012

Cardiac Science Initiates Recall of AEDs


Company blames supplier for faulty component.

Pro-Dex Divests Fractional Horsepower Motor Business


Sale is part of continued focus on medical technology markets.

Companies Partner to Develop Point-of-Care Device for Flu Diganosis


DARPA contract calls for flexible, highly adaptable device.

Secretary of Labor Solis and Jill Biden Visit DG Medical


BioOhio workforce development and Sinclair Community College partnership highlighted.

Symmetry Resolves SEC Charges


Former executives charged with accounting fraud.

Orchid Acquires Sandvik Medical Solutions


Acquisition expands Orchid's contract manufacturing capabilities.

Orthofix Inches Closer to Resolving Legal Matters


Company is prepared to pay $43 million to close investigation into bone-growth lawsuit.

Johnson & Johnson Names New CEO


Company promotes medical device and diagnostic unit chief.

Medical Device Accelerator Program Launches in Memphis


Program aims to provide seed funding and FDA savvy for startup firms.

Latest Purchase Adds to Greatbatch's Design Stable


Firm specializes in neuroscience market.

ConvaTec Has New Face at the Top


Former CEO will stay on board for a transition period.

Startup Secures Third Funding Round for Cuffless Blood Pressure Measurement


Company is gearing up for FDA clearance next year.

Merit Medical Hit With Warning Letter Over Coating Process


Agency deems modified guidewires 'adulterated.'

Senator Warns of Impact from Price Controls Proposal


Republican encourages 'further dialogue' to explore alternatives.

Stryker, Federal Prosecutors Reach Deal in Bone Growth Lawsuit


Company pays $15 million fine, pleads to one misdemeanor charge.

FDA Working to Reduce Risk from Reused Medical Devices


Creates new website to inform patients about tools available to minimize infection risk.

FDA OKs HeartNavigator System from Philips


GPS-like HeartNavigator creates a three-dimensional image.

Israeli Company Working to Resolve Import Ban


Most products from Oridion Systems back on track for U.S. shipment.

Tighter Controls Urged for European Medical Devices


French breast implant uproar highlights need for regulatory overhaul, advocates argue.

OnCore and Proven Process Form Medtech Manufacturing Alliance


Partnership leverages each firm's talents to provide a complete solution of medical device customers.

Stryker's CEO Steps Down Abruptly


Departure is immediate and CFO takes the reins temporarily.

Synthes Accuses Stryker of Raiding Sales Staff


Three former sales representatives named in lawsuit.

Symmetry Closes Deal for Codman Business


Purchase expected to add $60 million in new sales.

Phillips Plastics to Rebrand as Phillips-Medisize Corp.


Name change is the result of last summer's Medisize buyout.

Smith & Nephew Settles U.S. Bribery Allegations


Company paying $22 million to end investigation over suspected bribing of Greek healthcare providers.

Merit Medical Buys Ostial Solutions


Ostial founded by family with innovative product development track record.

KCI Announces New Management Structure


Company also pursuing strategic alternatives for its Therapeutic Support Systems business.

FDA and Industry Reach Tentative User Fee Deal


Industy has agreed to doubled fees for better review times and other improvements..

January 2012

Custom Spine Gets ISO Certification and CE Mark


Clearance opens international markets for the firm.

MichBio Forms Medical Device Advocacy Committee


New group within association to tackle device-specific issues, grow business in the state.

Cook Medical and Cardinal Health Ink Distribution Deal


Agreement involves central venous catheter sets.

AngioDynamics to Acquire Navilyst Medical for $372 Million


Deal expected to double AndioDynamics share of the vascular access market.

Bain Capital Completes Buyout of MDT's Physio-Control Unit


Revenue grew 1 percent in constant currency sales in FY2011.

FDA Gives Green Light to Medtronic's DF4 Connector System


System includes right ventricular lead and connector used with ICDs.

Abbott Labs Plans Additional Layoffs


Cuts mostly come from stent-making business.

J&J's Q4 Results Take Big Hit on Special Charges, Full-Year Sales Up


Cost of hip recall significantly impacts the quarter.

Is Europe’s DES Market Softening?


A new report suggests the sector is slowing, but could be buoyed by new biotech offerings.

Covidien Appoints New Leader for Vascular Therapies Business


Latest hire will manage 4,000 global employees.

First Patient Enrolled in Medtronic Clinical Trial Comparing Two Atrial Fibrillation Ablation Devices


Results expected in two years.

Sanovas Expands Headquarters and Opens Manufacturing Site


Facility to produce medical devices for detecting and treating lung cancer and pulmonary disease.

Helix to Provide Gore with Silicone Tubing


Tubes will be used for single-use pharmaceutical kits.

House Dems Want Hearing to Discuss Device Safety


Letter sent to GOP leaders said info is critical to user-fee reauthorization talks.

St. Jude Reports Good News from FAME II Trial


Analyzed data to be available soon.

Covidien Recalls Duet TRS Device Used in Thoracic Procedures


Company says device remains safe for other indications.

FDA Expands Indication for Gore's Endovascular Graft


New approval includes treatment of aortic tears or ruptures.

Medtronic Rolls Out New AAA Stent in Europe


Company gains CE mark for second generation of Endurant stent; U.S. OK expected this year.

MedShape Makes Full Release of ExoShape Soft-Tissue Fastener


New surgical instrumentation and refined surgical techniques aid ACL repair.

CareFusion's Alaris Infusion Pump Certified for Data Encryption


Company says it is the first to achieve new federal standard.

Terumo Buys Onset Medical Corp.


Purchase extents Terumo's access device business.

India Planning to Revise its Drugs and Cosmetics Act


Government attempting to boost device sector by separating it from drugs.

Zimmer Buys Instrument Maker


Ortho giant will add Synvasive's product line to its recon division.

U.K. Firm Expands Medical Business with Latest Purchase


Pays $30 million for American contract manufacturer.

Patient-Matched Technology Shows Promise for Healthcare System


Study validates Smith & Nephew knee replacement technology.

Mindray Medical Looking to Healthcare IT Realm for Growth


Acquires majority stakes in two Chinese firms.

New Group Targets Global Regulatory Harmonization


Association takes on drug and device regulatory issues.

AdvaMed Restructures Small Company Council


Group within association reorganizes efforts on behalf of its small to midsize members.

RTI International Metals Scoops Up Remmele Engineering


Purchase boosts medical device business opportunities for RTI.

FDA Zeros in on Surgical Mesh Use in Women


Agency wants more safety data when used to treat incontinence.

S&N Sells Control of Biologics Division to Private Equity


Ortho company will use funds to increase new product R&D.

Boston Scientific Ready to Fight IRS Over Taxes


Inter-company transfer pricing of technology license agreements is at issue.

Fujifilm Focusing on Healthcare Market with SonoSite Purchase


Deal is worth nearly $1 billion.

St. Jude Expands Cardio Facility


Predicted growth in cardiovascular business means more space is required.

Contact Lens Recall Spurs Lawsuit


Class action filing accuses Cooper Companies of artificially inflating stock.

Synthes Executive Joins Former Colleagues in Prison


Ex-vice president receives eight-month term over illegal clinical trials.

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