Medical Device Week articles from September 2006

Medical Device Week archives from September 2006

Holiday notice.
September 1, 2006... Holiday notice Medical Device Daily's offices will be closed on Monday, Sept. 4, in observance of the Labor Day holiday in the U.S., and no issue will be published that day. The next issue of MDD will be published on Tuesday, Sept. 5. ...

FDA gathers new task force focused on tissue bank issues.
September 1, 2006... FDA gathers new task force focused on tissue bank issues By MARK McCARTY Medical Device Daily Washington Editor WASHINGTON -- The surge of device recalls seems to have ebbed, the Vioxx story has faded from the front pages, and...

VELscope unit offers newest tech to detect oral cancer.
September 1, 2006... VELscope unit offers newest tech to detect oral cancer By DAVID KOSUB Medical Device Daily Contributing Writer Canadian and U.S. research agencies are joining forces to promote early diagnosis of oral cancer through research into a...

Report from Europe.
September 1, 2006... Report from Europe Viacortis project engenders new tissue-viability process A Medical Device Daily Staff Report Viacortis, a EUREKA project being carried out in Lithuania, has developed new techniques to monitor the viability of...

NIDA genetic study focuses on vulnerability to alcohol.
September 1, 2006... NIDA genetic study focuses on vulnerability to alcohol By KAREN YOUNG Medical Device Daily Staff Writer Alcoholism wrecks or severely impacts many lives in the U.S., from the alcoholic himself/herself to those around them: family,...

Court report.
September 1, 2006... Court report Pioneer says appeals court finds in its favor in case with Stryker A Medical Device Daily Staff Report Pioneer Surgical Technology (Marquette, Michigan) said the U.S. Court of Appeals for the Federal Circuit affirmed...

Financings roundup.
September 1, 2006... Financings roundup OmniGuide adds $20M round; IsoTis in $5M credit facility A Medical Device Daily Staff Report OmniGuide (Cambridge, Massachusetts), a developer of hollow-core photonic bandgap optical fibers, reported the closing...

Genesis opens Los Angeles HQ.(head quaters)(Brief article)
September 1, 2006... Genesis opens Los Angeles HQ Genesis Bioventures reported that it has opened its new corporate headquarters in Los Angeles, completing the company's planned relocation to California from Vancouver, British Columbia. Last year the...

Grants/contracts news.
September 1, 2006... Grants/contracts news Paul Allen Foundation gives $5M to Seattle cancer center A Medical Device Daily Staff Report A $5 million grant from the Paul G. Allen Family Foundation is expected to accelerate Fred Hutchinson Cancer...

Agreements.
September 1, 2006... Agreements Cardiovascular Consultants to deploy Allscripts' solutions A Medical Device Daily Staff Report InforMedix Holdings (Rockville, Maryland), a developer of systems for improving medication adherence and enabling patients to...

Product Briefs.
September 1, 2006... Product Briefs * Biophan Technologies (Rochester, New York) reported that the U.S Patent and Trademark Office has issued patent No. 7,091,412, which covers the placement of nanomagnetic coatings on medical devices that are exposed to...

Atrium receives 510(k) okay for its iVENA Vascular Patch.
September 1, 2006... Atrium receives 510(k) okay for its iVENA Vascular Patch A Medical Device Daily Staff Report Atrium Medical (Hudson, New Hampshire) repor-ted receiving FDA 510K clearance for a new vascular implant device called the iVena Vascular...

People in Places.
September 1, 2006... People in Places * Dennis Meteny has been named president/CEO of Cygnus Manufacturing (Pittsburgh). Meteny previously was president/CEO of Respironics (Pittsburgh). Cygnus makes non-invasive medical devices, health and safety components,...

Fair benchmarking plans key CMS reimbursement reform.
September 5, 2006... Fair benchmarking plans key CMS reimbursement reform By MARK McCARTY Medical Device Daily Washington Editor WASHINGTON -- Software is a vital part of any modern endeavor in healthcare, but its influence on skeptics in the medical...

TheraTogs is a 'wearable hugs' maker right at home in Telluride.
September 5, 2006... BioWest 2006 TheraTogs is a 'wearable hugs' maker right at home in Telluride By DON LONG Medical Device Daily Managing Editor DENVER -- While Colorado's biggest city sprawls out on a flat plain, the rest of the state can...

International report.
September 5, 2006... International report Matria Healthcare signs accord for Aussie wellness programs A Medical Device Daily Staff Report Matria Healthcare (Marietta, Georgia) said it has signed an agreement with Revive Group, located in the Australian...

FDA approves modifications to NMT's PFO trial for migraines.
September 5, 2006... FDA approves modifications to NMT's PFO trial for migraines By HOLLAND JOHNSON Medical Device Daily Associate Managing Editor NMT Medical (Boston) reported that it has received conditional approval from the FDA for modifications...

Court report.
September 5, 2006... Court report Two firms dispute Diomed's assertions about patent suit A Medical Device Daily Staff Report In response to Diomed's (Andover, Massachusetts) assertions in a recently issued press statement (Medical Device Daily, Sept....

Deals roundup.
September 5, 2006... Deals roundup Invitrogen in $29M Sentigen buy; Applied Imaging in $18M merger A Medical Device Daily Staff Report Invitrogen (Carlsbad, California) and Sentigen Holding (Phillipsburg, New Jersey) reported a merger agreement for...

Grants/contracts.
September 5, 2006... Grants/contracts Foster-Miller to provide device coating work for Micell A Medical Device Daily Staff Report Micell Technologies (Raleigh, North Carolina) reported that it has engaged Foster-Miller (Boston) for further development...

Financings roundup.
September 5, 2006... Financings roundup Octagon completes $10M round; Acusphere in private share sale A Medical Device Daily Staff Report Octagon Research Solutions (Wayne, Pennsylvania), a company working for the electronic transformation of clinical...

Briefly Noted.
September 5, 2006... Briefly Noted Calypte gets new stock symbol Diagnostics test maker Calypte Biomedical (Lake Oswego, Oregon) reported being issued a new ticker symbol (CBMC) and its common stock is being quoted under the new symbol on the Pink Sheets....

Product Briefs.(product introductions)(Applied Biosystems/MDS Sciex)
September 5, 2006... Product Briefs * Allergan (Sydney, Australia) reported the international launch of its LAP-BAND Advanced Platform (AP) System with Omniform Adjustable Gastric Band, its latest offering in laparoscopic adjustable gastric banding for the...

S&N reconstruction rolls out Emperion Modular Hip System.(Smith and Nephew Perry)(Brief article)
September 5, 2006... S&N reconstruction rolls out Emperion Modular Hip System The Orthopaedic Reconstruction division of Smith & Nephew (Memphis) reported launch of the Emperion Modular Hip System for primary and revision total hip arthroplasty, with...

People in Places.(James Risher and Mark Zorko joins Del Global Technologies Corp.)(Brief article)
September 5, 2006... People in Places * James Risher has been appointed CEO of Del Global Technologies (Valhalla, New York), and Mark Zorko has been named company CEO. Risher was appointed interim CEO of Del Global, effective July 22. Zorko has been a CFO...

Major milestone for sector, heart patients.
September 6, 2006... Major milestone for sector, heart patients Humanitarian exemption granted to Abiomed for AbioCor heart By DON LONG Medical Device Daily Managing Editor Marking a major milestone not only for itself but also for the entire...

Washington roundup.
September 6, 2006... Washington roundup CMS's McClellan calls it quits, successor possibilities abound By MARK McCARTY Medical Device Daily Washington Editor WASHINGTON -- Mark McClellan, the head administrator for the Centers for Medicare &...

Report from Europe.
September 6, 2006... Report from Europe Mortality data raise questions of DES safety at ESC meeting A Medical Device Daily Staff Report At the European Society of Cardiology (ESC)/World Congress of Cardiology (WCC; Sophia, Antipolis, France) annual...

FDA examining guidance for emergency research.
September 6, 2006... FDA examining guidance for emergency research By AARON LORENZO Medical Device Daily Contributing Writer WASHINGTON -- Blood substitute companies and others developing emergency-use products might be facing new clinical study...

Financings roundup.
September 6, 2006... Financings roundup Northfield puts $100M on shelf; HDC gets $1M loan from Quirk A Medical Device Daily Staff Report Northfield Laboratories (Evanston, Illinois) reported that it has filed a shelf registration statement with the...

<I>MDD</I> releases new report on orthopedics market.
September 6, 2006... MDD releases new report on orthopedics market The publishers of Medical Device Daily have just released a new 200-page report focusing on the orthopedics sector, Orthopedics 2006 -- Trends, Challenges and Opportunities. The report provides...

Matria completes Facet sale; KBL to buy Summer Infant.
September 6, 2006... Matria completes Facet sale; KBL to buy Summer Infant A Medical Device Daily Staff Report Matria Healthcare (Marietta, Georgia) reported completing the sale of Facet Technologies (also Marietta), the company's subsidiary specializing...

Agreements roundup.
September 6, 2006... Agreements roundup SHARE selects Affymetrix for genome association study A Medical Device Daily Staff Report Affymetrix (Santa Clara, California) reported that it has been selected by the SNP Health Association REsource (SHARE)...

Grants roundup.
September 6, 2006... Grants roundup Karta awarded $75M by USAF for modernization of IT services A Medical Device Daily Staff Report Karta Technologies (San Antonio) said it was awarded a $75 million indefinite delivery/indefinite quantity (ID/IQ)...

Product Briefs.
September 6, 2006... Product Briefs * Acacia Research (Newport Beach, California) reported that its CombiMatrix group's subsidiary, CombiMatrix Molecular Diagnostics (CMDX) has launched its first molecular diagnostic service. This offering uses CMDX'...

CryoCath granted IDE approval for AF trial with Arctic Front.
September 6, 2006... CryoCath granted IDE approval for AF trial with Arctic Front A Medical Device Daily Staff Report CryoCath Technologies (Montreal) reported receiving conditional approval from the FDA for its STOP AF trial, allowing the company to...

People in Places.
September 6, 2006... People in Places * Thomas Etergino has resigned as vice president and CFO of AtriCure (West Chester, Ohio). Until a successor is named, David Drachman, president/CEO, will manage company finances. AtriCure develops surgical devices that...

AbioCor approval a bellwether, careful roll-out an 'obligation'.
September 7, 2006... AbioCor approval a bellwether, careful roll-out an 'obligation' By DON LONG Medical Device Daily Managing Editor While the FDA's approval this week for commercialization of the AbioCor artificial implantable heart is a clear...

Study shows benefits of Activa system in Parkinson's patients.
September 7, 2006... Study shows benefits of Activa system in Parkinson's patients By HOLLAND JOHNSON Medical Device Daily Associate Managing Editor According to the results of a major randomized, controlled, multicenter study published in the Aug. 31...

Report from Europe.
September 7, 2006... Report from Europe Cordis touts Cypher's REALITY data superior to Taxus at WCC A Medical Device Daily Staff Report Patients who receive the Johnson & Johnson (J&J; New Brunswick, New Jersey) Cypher sirolimus-eluting coronary stent...

Financings roundup.
September 7, 2006... Financings roundup VC firm closes $375M fund; NeoStem in private $1.75M round A Medical Device Daily Staff Report Thomas, McNerney & Partners (Stamford, Connecticut), a healthcare venture capital firm that invests in life science...

Court report.
September 7, 2006... Court report ACT settles patent dispute over nuclear transfer cloning tech A Medical Device Daily Staff Report Advanced Cell Technology (ACT; Alameda, California) reported that it has settled a patent dispute involving certain...

Deals roundup.
September 7, 2006... Deals roundup Natus to buy EEG/PST specialist Deltamed and its IT-Med unit A Medical Device Daily Staff Report Natus Medical (San Carlos, California) reported that it has agreed to acquire Deltamed (Paris) and its wholly owned...

Grants/contracts.
September 7, 2006... Grants/contracts NIGMS awards $13 million over years to new wound centers A Medical Device Daily Staff Report The treatment of burns, diabetic ulcers, bedsores and other wounds -- even wounds from gunshots -- may improve, with a...

Agreements roundup.
September 7, 2006... Agreements roundup Sharp Health partners with Cerner for systems information A Medical Device Daily Staff Report Sharp HealthCare (San Diego), which describes itself as one of the largest integrated healthcare systems in...

Report: MRI a $4 billion industry by 2010.
September 7, 2006... Report: MRI a $4 billion industry by 2010 With the development of open systems, magnetic resonance imaging (MRI) has evolved into the best imaging procedure for many organs and structures, including the brain, spine, bones, and joints,...

Lifeblood launches new unit, Cell Preservation Solutions.
September 7, 2006... Lifeblood launches new unit, Cell Preservation Solutions A Medical Device Daily Staff Report Lifeblood Medical (Freehold, New Jersey) reported that it has established Cell Preservation Solutions, a subsidiary that will conduct research...

Product Briefs.
September 7, 2006... Product Briefs * Automated Cellular Imaging System (Aliso Viejo, California) reported availability of the first ACIS III (Automated Cellular Imaging System) to be used in beta testing. Clarient is a technology and services resource for...

Cyberkinetics wins HUD okay for Andara spinal stimulator.
September 7, 2006... Cyberkinetics wins HUD okay for Andara spinal stimulator A Medical Device Daily Staff Report Cyberkinetics Neurotechnology Systems (Foxborough, Massachusetts) reported that it has received FDA notification that the company's Andara...

People in Places.(appointment of Alan Aria as Managing Director)(appointment of Melanie Brensinger as Senior Vice President)(appointment of Gabor Bethlendy as sales manager)(appointment of Jeff Flammang as President
September 7, 2006... People in Places * Alan Aria has been named managing director and Melanie Brensinger has been named senior vice president of Global Sponsor Finance (Norwalk, Connecticut), a GE Commercial Finance company. Most recently, Aria was team...

Lung cancer still deadliest; breast cancers diagnoses down.
September 8, 2006... Lung cancer still deadliest; breast cancers diagnoses down By MARK McCARTY Medical Device Daily Washington Editor BETHESDA, Maryland -- The National Cancer Institute (NCI; Bethesda, Maryland) released a report on cancer for 2006,...

Public Citizen wants Cyberonics device pulled from U.S. market.
September 8, 2006... Public Citizen wants Cyberonics device pulled from U.S. market By HOLLAND JOHNSON Medical Device Daily Associate Managing Editor Watchdog group Public Citizen (Washington) has called for U.S. regulators to pull Cyberonics'...

FDA issues guidance for In Vitro Diagnostic Index Assays.
September 8, 2006... FDA issues guidance for In Vitro Diagnostic Index Assays By KAREN YOUNG Medical Device Daily Staff Writer The FDA has issued draft regulatory guidance for clinical laboratories and industry regarding so-called In Vitro Diagnostic...

Financings roundup.
September 8, 2006... Financings roundup Diagnostics firm Rosetta files to raise $39M in IPO By Karen Pihl-Carey Medical Device Daily Senior Staff Writer And MDD Staff Reports In what could bring the company $39 million, Rosetta Genomics...

Deals roundup.(Company overview)
September 8, 2006... Deals roundup Quest Diagnostics completes buy of Enterix and InSure test A Medical Device Daily Staff Report Quest Diagnostics (Lyndhurst, New Jersey), a provider of diagnostic testing, information and services, said that it has...

Agreements roundup.
September 8, 2006... Agreements roundup Affymetrix in pact with PC to develop microarray diagnostics A Medical Device Daily Staff Report Affymetrix (Santa Clara, California) and Partners HealthCare (PC; Boston) said that they have entered into a...

Grants/contracts.
September 8, 2006... Grants/contracts OSI Systems gets $10.5M contract w/Fortune 500 company A Medical Device Daily Staff Report OSI Systems (Hawthorne, California), said that its Optoelectronics and Manufacturing division, OSI Optoelectronics, has...

Briefly Noted.
September 8, 2006... Briefly Noted Cleveland Clinic, AATS to hold summit The Cleveland Clinic Kaufman Center for Heart Failure (Cleveland) and the American Association for Thoracic Surgery (Beverly, Massachusetts) will host a national summit on heart...

Product Briefs.
September 8, 2006... Product Briefs * CAS Medical Systems reported that it has received FDA 510(k) clearance for expanded use of its Fore-Sight Absolute Cerebral Oximeter in additional patient populations including children over 40 kg and infants. CAS says the...

People in Places.
September 8, 2006... People in Places * Rick Belford has been promoted to vice president of quality assurance and regulatory affairs, and Tom Cook to director of customer support at IntraOp Medical (Sunnyvale, California). IntraOp makes the Mobetron system, a...

Celsion Names New Executive Leadership.
September 8, 2006... Celsion Names New Executive Leadership Lawrence Olanoff, MD, PhD, has resigned as president/CEO of Celsion (Columbia, Maryland). Olanoff had been in his position at Celsion since July 2005. Previously he was vice president scientific...

FDA seeks to clarify guidance on analyte specific reagents.
September 11, 2006... 2nd of two stories FDA seeks to clarify guidance on analyte specific reagents By KAREN YOUNG Medical Device Daily Staff Writer The FDA has issued draft regulatory guidance for the medical device industry on commercially...

Webcast demonstrates hiatal hernia repair with Surgisis ES.
September 11, 2006... Webcast demonstrates hiatal hernia repair with Surgisis ES By CYNTHIA DRAKE, RN Medical Device Daily Contributing Writer The University of Washington School of Medicine (Seattle) recently presented a live webcast of a roundtable...

Washington roundup.
September 11, 2006... Washington roundup FDA fines Red Cross $4 million for violation of consent decree By MARK McCARTY Medical Device Daily Washington Editor The FDA formally notified the American Red Cross (ARC; Washington) of its intent to levy...

Deals roundup.(Company overview)
September 11, 2006... Deals roundup TriPath agrees to $350M buyout; Elron reduces NetVision holdings A Medical Device Daily Staff Report TriPath Imaging (Burlington, North Carolina), a maker of products to detect and treat cancer, officially agreed to...

Agreements roundup.
September 11, 2006... Agreements roundup SurModics and X-Cell enter into licensing accord for stent system A Medical Device Daily Staff Report SurModics (Eden Prairie, Minnesota) and X-Cell Medical (Princeton, New Jersey) reported that they have entered...

Grants/contracts.
September 11, 2006... Grants/contracts ATS Medical in pact with Novare; Hospira, HealthTrust in accord A Medical Device Daily Staff Report ATS Medical (Minneapolis), a maker of cardiac surgery products and services, reported an exclusive distribution...

Financings roundup.
September 11, 2006... Financings roundup Daiichi Sankyo invests $60M in $180M Kearney Venture fund A Medical Device Daily Staff Report Daiichi Sankyo (Tokyo) reported that it will enhance its research and development activities by investing in Kearney...

Briefly Noted.
September 11, 2006... Briefly Noted Biophan launches new web site Biophan Technologies (Rochester, New York), a developer of next-generation medical technology, has unveiled a new company web site, available on-line at www.biophan.com. "We've enhanced...

Men concerned about prostate test accuracy.
September 11, 2006... Men concerned about prostate test accuracy A Harris Interactive survey sponsored by Gen-Probe (San Diego) and conducted in July 2006 of 1,000 males age 45 to 70 years found that more than half (53%) of men are concerned with the accuracy of...

Product Briefs.
September 11, 2006... Product Briefs Medtronic (Minneapolis) reported U.S. availability of the CD Horizon Engage Plate Spinal System for the lumbar (lower) spine. This system is designed to stabilize vertebrae using multi-axial bolts and a revision option for...

People in Places.
September 11, 2006... People in Places * Peter Nicklin has been named corporate vice president of Baxter International (Deerfield, Illinois) and president of Baxter Europe. Baxter International is a subsidiary of Baxter World Trade Corporation (Fort Lauderdale,...

Goodroe study questions touted DES benefits over bare-metal.
September 12, 2006... Goodroe study questions touted DES benefits over bare-metal By HOLLAND JOHNSON Medical Device Daily Associate Managing Editor Have drug-eluting stent (DES) devices been over-hyped? The benefits of switching from bare-metal...

Deals roundup.(Company overview)
September 12, 2006... Deals roundup MAI in $80M Medegen purchase; Roundtable buys Aspen Surgical A Medical Device Daily Staff Report Medical Action Industries (MAI; Hauppauge, New York), a supplier of disposable medical and surgical disposable products,...

Report from Europe.
September 12, 2006... Report from Europe AtriCure's Isolator Transpolar wins CE-mark for arrhythmias A Medical Device Daily Staff Report AtriCure (West Chester, Ohio) reported receiving CE-marking for its Isolator Transpolar System for the treatment of...

Publisher of <I>MDD</I> and 50 other newsletters Thompson-owned.
September 12, 2006... Publisher of MDD and 50 other newsletters Thompson-owned ATLANTA -- Medical Device Daily, two weekly newsletters and two monthly newsletters in the MDD group -- along with about 50 other newsletters published by American Health Consultants...

Financings roundup.
September 12, 2006... Financings roundup Chinese monitoring firm Mindray files for IPO of up to $276M A Medical Device Daily Staff Report Chinese medical device maker Mindray Medical International (Shenzhen, China) has filed with the Securities and...

Court report.
September 12, 2006... Court report Innogenetics wins $7M from Abbott Labs in jury ruling A Medical Device Daily Staff Report Innogenetics (Gent, Belgium) reported that a jury in the U.S. District Court for the Western District of Wisconsin has ruled...

Washington roundup.
September 12, 2006... Washington roundup Pushback seen likely to stymie CMS's proposed cuts to Part B By MARK McCARTY Medical Device Daily Washington Editor And AARON LORENZO, MDD Contributing Writer The Center for Medicare & Medicaid Services...

Agreements roundup.
September 12, 2006... Agreements roundup FujiFilm adding iCAD to its FCRm product offerings A Medical Device Daily Staff Report iCAD (Nashua, New Hampshire) reported that FujiFilm Medical System (Stamford, Connecticut) will offer iCAD products through...

Cleveland Clinic, AATS to hold summit.
September 12, 2006... Cleveland Clinic, AATS to hold summit A Medical Device Daily Staff Report The Cleveland Clinic Kaufman Center for Heart Failure (Cleveland) and the American Association for Thoracic Surgery (Beverly, Massachusetts) will host a national...

Product Briefs.
September 12, 2006... Product Briefs * Affymetrix (Santa Clara, California) reported publication of the "MicroArray Quality Control (MAQC)" study, a collaborative effort led by the FDA that included 137 scientists from private and public sector laboratories....

People in Places.
September 12, 2006... People in Places * Louis Brenner, MD has been named senior vice president, and Mohammed Salem, PhD, has been named vice president of regulatory affairs at Advanced Magnetics (Cambridge, Massachusetts). Previously Brenner was senior...

Non-excitatory impulses' from Optimizer effective for CHF.
September 13, 2006... Heart Failure Society of America annual meeting 'Non-excitatory impulses' from Optimizer effective for CHF By HOLLAND JOHNSON Medical Device Daily Associate Managing Editor A technology which has been likened to pacing of the...