Medical Device Week articles from October 2005

Medical Device Week archives from October 2005

Genzyme unveils targeted test to aid in treatment of NSCLC.
October 3, 2005... Genzyme unveils targeted test to aid in treatment of NSCLC By HOLLAND JOHNSON Medical Device Daily Associate Managing Editor Genzyme (Cambridge, Massachusetts) reported the commercial availability of a new laboratory test to help...

FDA, U.S. health should give up mantra of ‘gold standard'.
October 3, 2005... FDA, U.S. health should give up mantra of ‘gold standard' By DON LONG Medical Device Daily Managing Editor The FDA long has boasted of its position in the world as the "gold standard" for the regulation and promotion of...

International report.
October 3, 2005... International report MSI begins shipments of its VScan TB test kits to Africa A Medical Device Daily Staff Report Medical Services International (MSI; Edmonton, Alberta) said last week that it had begun shipping its VScan TB rapid...

Financings roundup.
October 3, 2005... Financings roundup Genomic Health's IPO gathers $60M for breast cancer test By JENNIFER BOGGS Medical Device Daily Staff Writer and Staff Reports Genomic Health (Redwood City, California) last week priced its initial...

Washington roundup.
October 3, 2005... Washington roundup CDRH sets session on reducing unnecessary radiation exposure A Medical Device Daily Staff Report The FDA's Center for Devices and Radiological Health has set a meeting for Oct. 31-Nov. 1 at the Gaithersburg...

Deals roundup.
October 3, 2005... Deals roundup AmeriPath, Specialty to merge; HealthTronics acquires patents A Medical Device Daily Staff Report Specialty Laboratories (Valencia, California) reported that it has signed a definitive merger agreement with AmeriPath...

Briefly Noted.(NanoSignal moves into new corporate offices)(Colorado Technical University opens Surgical Technology Program)(FoxHollow Technologies consolidates manufacturing facilities)
October 3, 2005... Briefly Noted Las Vegas corporate offices for NanoSignal NanoSignal (Las Vegas) said that new corporate offices have been established in Las Vegas. Earlier this week, the company reported that it had established a banking relationship...

Court report.
October 3, 2005... Court report Third Wave technology draws lawsuits and verdict appeal A Medical Device Daily Staff Report The Invader technology developed by Third Wave (Madison, Wisconsin) was the center of two legal actions last week, the subject...

Grants/contracts.
October 3, 2005... Grants/contracts $18.8M NIH grant will establish center for biomedical oncology A Medical Device Daily Staff Report The National Institutes of Health (Bethesda, Maryland) has awarded the Stanford University School of Medicine (Palo...

HCA creates new operating group, appoints new execs.
October 3, 2005... HCA creates new operating group, appoints new execs A Medical Device Daily Staff Report Hospital operator HCA (Nashville, Tennessee) reported an organizational change creating a third operating group, effective Jan. 1, 2006, which it...

People in Places.(Kathryn Liljestrand joins IsoTis Orthobiologics)(Walter Narajowski president Pathway Diagnostics)(Suntron announces Peter Harper's departure)(Brief Article)
October 3, 2005... People in Places Kathryn Liljestrand has joined IsoTis OrthoBiologics (Lausanne, Switzerland/Irvine, California) as vice president of marketing. Liljestrand most recently was director of patient advocacy at Smith & Nephew. IsoTis...

Product Briefs.
October 3, 2005... Product Briefs • Alcon (Fort Worth, Texas) said it has received FDA approval for the AcrySof Toric intraocular lens (IOL) for use in cataract patients with pre-existing corneal astigmatism. The AcrySof Toric lens is based on the...

CCS, MP TotalCare merged; pSivida to buy CDS for $104M.
October 4, 2005... CCS, MP TotalCare merged; pSivida to buy CDS for $104M By HOLLAND JOHNSON Medical Device Daily Associate Managing Editor Global private equity firm Warburg Pincus (New York) has acquired CCS Medical (Clearwater, Florida) for about...

Financings roundup.
October 4, 2005... Financings roundup Isotechnika enters into device accord with Atrium Medical By RANDALL OSBORNE Medical Device Daily Staff Writer and Staff Reports With positive preliminary Phase III data from its lead product for...

Report from Europe.
October 4, 2005... Report from Europe Report cites improvements in providing renal care in UK A Medical Device Daily Staff Report A report published last month by the Department of Health said that kidney patients in the UK are seeing a major change...

Panel develops guidelines for normal pressure hydrocephalus.
October 4, 2005... Panel develops guidelines for normal pressure hydrocephalus By KAREN YOUNG Medical Device Daily Staff Writer When Anthony Marmarou, PhD, began seeing more and more people with normal pressure hydrocephalus (NPH) in the clinic, he...

Frist initiated sale of his HCA shares in April, says report.
October 4, 2005... Court report Frist initiated sale of his HCA shares in April, says report A Medical Device Daily Staff Report According to a weekend newspaper report, Senate Majority Leader Bill Frist (R-Tennessee) was looking to sell shares of...

Deals roundup.
October 4, 2005... Deals roundup PolyMedica sells unit for $45M; Cell Robotics eyes Techventors A Medical Device Daily Staff Report PolyMedica (Woburn, Massachusetts) reported that it has sold its Women's Health Products Division (WHPD) to Amerifit...

Grants/contracts.
October 4, 2005... Grants/contracts U.S. Olympic Committee, GE work to advance athlete care A Medical Device Daily Staff Report The U.S. Olympic Committee (USOC; Colorado Springs, Colorado) and General Electric (Fairfield, Connecticut), a worldwide...

People in Places.
October 4, 2005... People in Places • Scott Wiese has joined spinal implant firm Alphatec Spine (Carlsbad, California) as vice president of business development and marketing. Wiese comes to Alphatec with more than 20 years of marketing and sales...

St. Vincent suspends its liver transplant program.
October 4, 2005... St. Vincent suspends its liver transplant program A Medical Device Daily Staff Report St. Vincent Medical Center (Los Angeles) reported that it has placed its liver transplantation program on temporary inactive status and that surgeons...

Product Briefs.(GE Healthcare introduces applications for Lunar Prodigy bone density system)(Iridex introduces OcuLight OR green laser)(Luminex introduces Luminex 200)
October 4, 2005... Product Briefs • GE Healthcare (Waukesha, Wisconsin) has unveiled what it termed "major pediatric application enhancements" for its Lunar Prodigy bone density system. The enhancements provide tools to evaluate the pediatric skeleton...

Financings roundup.
October 5, 2005... Financings roundup Angiotech, CombinatoRx in $42M collaborative agreement By HOLLAND JOHNSON Medical Device Daily Associate Managing Editor Angiotech Pharmaceuticals (Vancouver, British Columbia) reported this week that it...

Grants/contracts.
October 5, 2005... Grants/contracts NCI awards ‘major' part of its $144M nanotech initiative By KAREN YOUNG Medical Device Daily Staff Writer The National Cancer Institute (NCI), part of the National Institutes of Health (NIH; both...

Report from Europe.
October 5, 2005... Report from Europe Sorin launches pair of CRT products at Venice congress A Medical Device Daily Staff Report Sorin Group's (Milan, Italy) Cardiac Rhythm Management (CRM) business unit reported at the Venice Arrhythmias 2005...

Alimera and CDS in Phase III trial for intravitreal device.
October 5, 2005... Alimera and CDS in Phase III trial for intravitreal device By HOLLAND JOHNSON Medical Device Daily Associate Managing Editor Ophthalmic pharmaceutical company Alimera Sciences (Alpharetta, Georgia), in collaboration with Control...

Washington roundup.
October 5, 2005... Washington roundup Genetic privacy act gets some energy as Gingrich weighs in By AARON LORENZO Medical Device Daily Washington Writer WASHINGTON – Former Speaker of the House Newt Gingrich threw his weight behind a bill...

Synthetic Blood suspends one Phase II to focus on two others.
October 5, 2005... Synthetic Blood suspends one Phase II to focus on two others By DON LONG Medical Device Daily Managing Editor The clinical trial ground keeps shifting in the blood substitute group. The latest of these redirections comes from...

Briefly Noted.
October 5, 2005... Briefly Noted Tutogen Medical consolidates operations Tutogen Medical (West Patterson, New Jersey), a manufacturer of sterile biological implant products made from human (allograft) and animal (xenograft) tissue, reported that...

Court report.
October 5, 2005... Court report Saliva Diagnostic says ruling in case is a ‘major victory' A Medical Device Daily Staff Report Saliva Diagnostic Systems (SDS; Framingham, Massachusetts) said it received a favorable ruling in connection with...

Deals roundup.
October 5, 2005... Deals roundup Inverness closes BioStar buy; MGI Pharma adds Guilford A Medical Device Daily Staff Report Inverness Medical Innovations (Waltham, Massachusetts) said it completed its acquisition of Thermo BioStar (Louisville,...

People in Places.
October 5, 2005... People in Places • Roderick de Greef has joined Cambridge Heart (Bedford, Massachusetts) as CFO. Since March 2001, he has served as executive vice president, CFO and secretary of Cardiac Science, and played a key role in the recent...

Product Briefs.
October 5, 2005... Product Briefs • MIV Therapeutics (MIVT; Vancouver, British Columbia), a developer of next-generation biocompatible passive and drug-eluting stent coatings and drug delivery technologies for the treatment of cardiovascular disease,...

Kinetic Concepts restructures to focus on two businesses.(Brief Article)
October 5, 2005... Kinetic Concepts restructures to focus on two businesses A Medical Device Daily Staff Report Kinetic Concepts (KCI; San Antonio) reported that it would be making organizational changes to its U.S. business structure in order to further...

Financings roundup.
October 6, 2005... Financings roundup Alley Ventures, Ovum form med-tech investment accord A Medical Device Daily Staff Report Alley Ventures, a venture capital organization focusing on early stage funding for emerging companies in medical...

Kyphoplasty procedure termed very safe, effective technique.
October 6, 2005... Kyphoplasty procedure termed ‘very safe, effective technique' By CYNTHIA DRAKE, RN Medical Device Daily Contributing Writer Spine surgeons who performed a kyphoplasty procedure for osteoporotic and osteolytic vertebral...

International report.
October 6, 2005... International report St. Jude's Riata ICD leads receive approvals in Japan A Medical Device Daily Staff Report St. Jude Medical (St. Paul, Minnesota) reported receiving regulatory and reimbursement approvals from the Ministry of...

State of the Industry Report looks at status of med-tech.
October 6, 2005... State of the Industry Report looks at status of med-tech The Medical Device Daily State of the Industry Report 2005, a 504-page look at the status of the medical technology sector as of mid-year 2005, is now available. The book begins...

Deals roundup.
October 6, 2005... Deals roundup Caliper completes purchase of NovaScreen Bio for $22M A Medical Device Daily Staff Report Caliper Life Sciences (Hopkinton, Massachusetts) said it closed on its previously reported planned acquisition of NovaScreen...

Washington roundup.
October 6, 2005... Washington roundup Hoping to hasten adoption, HHS proposes new health IT rules A Medical Device Daily Staff Report New regulations that support adoption of e-prescribing and electronic health records were unveiled yesterday by...

Court report.
October 6, 2005... Court report Markman ruling backs BioGenex in slide-staining patent suit A Medical Device Daily Staff Report BioGenex (San Ramon, California) said it has received a favorable ruling in its patent infringement litigation against...

People in Places.
October 6, 2005... People in Places • CardioTech International (Wilmington, Massachusetts), a manufacturer of advanced medical device products treating cardiovascular disease, appointed Eric Walters as vice president and CFO and Thomas Carcel as...

West Pharmaceutical forms new unit with device focus.
October 6, 2005... West Pharmaceutical forms new unit with device focus A Medical Device Daily Staff Report West Pharmaceutical Services (Lionville, Pennsylvania) has named Robert Hargesheimer president of a newly formed business unit combining West's...

Product Briefs.
October 6, 2005... Product Briefs • Beckman Coulter (Fullerton, California) said it has begun shipping the Vidiera NsP Nucleic Sample Preparation platform, which it refers to as a versatile new solution for nucleic acid isolation, quantification,...

Higher death, hemorrhage rates halt Reopro study.
October 6, 2005... Higher death, hemorrhage rates halt Reopro study Safety concerns have put the brakes on a stroke study of Reopro (abciximab), a drug already long marketed as an antithrombotic adjunct to percutaneous coronary intervention. Partners...

Holiday notice.
October 7, 2005... Holiday notice Medical Device Daily's offices will be closed Monday, Oct. 10, in observance of the Columbus Day holiday in the U.S. and no issue will be published that day. The next issue of MDD will be published on Tuesday, Oct. 11. ...

Gainsharing is a hot topic on Hill, among industry groups.
October 7, 2005... Gainsharing is a hot topic on Hill, among industry groups By KAREN YOUNG Medical Device Daily Staff Writer Congresswoman Nancy Johnson (R-Connecticut) is holding a hearing today in Washington, for invited guests only, regarding...

Invitrogen in 2 more deals; Apogee sells its audio assets.
October 7, 2005... Invitrogen in 2 more deals; Apogee sells its audio assets A Medical Device Daily Staff Report Invitrogen (Carlsbad, California) said it has acquired Quantum Dot (Hayward, California) and the BioPixels business unit of BioCrystal (both...

Report from Europe.
October 7, 2005... Report from Europe Scientists probe ‘signatures' of genetic damage in cancer By SHARON KINGMAN Medical Device Daily Contributing Writer and Staff Reports A strategy to compare the genomes of cells from human tumors...

Anterior OK for Visante OCT brings focus to front of eye.
October 7, 2005... Anterior OK for Visante OCT brings focus to front of eye By HOLLAND JOHNSON Medical Device Daily Associate Managing Editor While much of the focus has been on the posterior region – or back of the eye – in the field of...

Washington roundup.
October 7, 2005... Washington roundup Interim FDA boss decides to leave NCI position for now By AARON LORENZO Medical Device Daily Washington Writer WASHINGTON – Newly named acting FDA Commissioner Andrew von Eschenbach has temporarily...

Grants/contracts.
October 7, 2005... Grants/contracts Georgia university researchers win $5.7M from GRA, industry A Medical Device Daily Staff Report The Georgia Research Alliance (GRA; Atlanta) said that 20 university-industry projects received awards through its...

MicroMed retains PR firm.
October 7, 2005... MicroMed retains PR firm MicroMed Cardiovascular (Houston), a manufacturer of miniaturized implantable ventricular assist technology, reported that it has retained CCG, which it called one of the country's leading investor relations and...

Financings roundup.
October 7, 2005... Financings roundup NAS in new $5M credit line; Zynex in $400K credit facility A Medical Device Daily Staff Report North American Scientific (NAS; Chatsworth, California) said it has executed a loan and security agreement with...

CryoLife hosts symposium.
October 7, 2005... CryoLife hosts symposium CryoLife (Kennesaw, Georgia), a biomaterials and biosurgical device company, is conducting a cardiac reconstruction symposium utilizing human heart valves and tissues at its corporate headquarters training facility...

Deals roundup.
October 7, 2005... Deals roundup Ventiv in $185M inChord buy; Genzyme in license accord A Medical Device Daily Staff Report Ventiv Health (Somerset, New Jersey) has completed its acquisition of inChord Communications (Westerville, Ohio), which it...

Physician opinion yet to be clear on gainsharing issue.
October 7, 2005... Physician opinion yet to be clear on gainsharing issue The American Medical Association (AMA; Chicago) does not have a policy on gainsharing, and a spokesperson told Medical Device Daily that the organization could not offer a...

People in Place.
October 7, 2005... People in Place • Roger Gale, chairman of the board of Calypte Biomedical (Lake Oswego, Oregon), will become the company's interim CEO. Gale has been chairman since November 2004. He succeeds Dr. Richard George, who has resigned as...

Product Briefs.
October 7, 2005... Product Briefs • Eastman Kodak (Rochester, New York) said it has obtained FDA approval for enhancements to its mammography computer-aided detection (CAD) system, and the enhanced software is now available. New software for the Kodak...

Holiday notice.
October 11, 2005... Holiday notice Medical Device Daily's offices were closed Monday, Oct. 10, in observance of the Columbus Day holiday in the U.S. No issue was published that day. SOURCE-Medical Device Daily

St. Jude says cosmic radiation can have affect on older ICDs.
October 11, 2005... St. Jude says cosmic radiation can have affect on older ICDs By HOLLAND JOHNSON Medical Device Daily Associate Managing Editor In an incident worthy of an episode of the now-syndicated X-Files television program, St. Jude Medical...

Breast cancer panel: needle biopsy better than surgical.
October 11, 2005... Breast cancer panel: needle biopsy better than surgical By KAREN YOUNG Medical Device Daily Staff Writer Four years after they first convened, a panel of 23 breast cancer experts has reached a consensus that newer, less-invasive...

Report from Europe.
October 11, 2005... Report from Europe NHS's counter-fraud leader heading up European network A Medical Device Daily Staff Report Jim Gee, chief executive of the UK National Health Service's Counter Fraud and Security Management Service, has been...

Vest from Game Ready helps surgeons to keep their cool.
October 11, 2005... Vest from Game Ready helps surgeons to keep their cool By KIM URQUHART Medical Device Daily Staff Writer Keeping cool during long surgeries helps surgeons keep a cool head. The new Active Cooling Vest from CoolSystems (doing...

Washington roundup.
October 11, 2005... Washington roundup Stakeholders continue push to delay power mobility changes A Medical Device Daily Staff Report WASHINGTON – Opponents to pending implementation of a Centers for Medicare & Medicaid Services (CMS; Baltimore)...

Deals roundup.
October 11, 2005... Deals roundup PerkinElmer to sell Fluid unit; Beckman Coulter to buy DSL A Medical Device Daily Staff Report PerkinElmer (Wellesley, Massachusetts) reported its intention to divest its Fluid Sciences business segment to increase,...

Financings roundup.
October 11, 2005... Financings roundup Vasogen unit in placement; Biosite boosts share reserve A Medical Device Daily Staff Report Vasogen (Toronto) reported that its wholly owned Irish subsidiary, Vasogen Ireland (Dublin), has signed definitive...

Microfabrica relocates to Van Nuys, California.
October 11, 2005... Microfabrica relocates to Van Nuys, California Microfabrica (Van Nuys, California), which focuses on micro-device and micro-system fabrication, said it has moved its factory and corporate headquarters from Burbank to a new facility in Van...

Briefly Noted.
October 11, 2005... Briefly Noted Lifestem to offer stem cell collection and storage CalbaTech (Irvine, California), an emerging life sciences company concentrating on providing products and platforms to the research market for biotech and pharmaceutical...

People in Places.
October 11, 2005... People in Places • Mark Hurtt, MD, has been named chief medical officer of Boston Life Sciences (Boston), focused on diagnostic and therapeutic products for diseases of the central nervous system. Most recently, Hurtt was senior...

Product Briefs.
October 11, 2005... Product Briefs • AMI Semiconductor (Pocatello, Idaho), a maker of integrated mixed-signal and structured digital products, reported the availability of a reference design and support materials for a complete DSP-based electronic...

FDA says Procleix Tigris ‘not equivalent' to eSAS.
October 11, 2005... FDA says Procleix Tigris ‘not equivalent' to eSAS A Medical Device Daily Staff Report Gen-Probe (San Diego) reported last week that the FDA has notified it that the agency considers the Procleix Tigris system "not substantially...

With 1st Endeavor PMA module, Medtronic steps closer to DES.
October 12, 2005... With 1st Endeavor PMA module, Medtronic steps closer to DES By HOLLAND JOHNSON Medical Device Daily Associate Managing Editor In a move that takes the company one step closer to having a drug-eluting stent (DES) on the U.S. market,...

ev3 continues on growth path via bid for rest of MTI shares.
October 12, 2005... ev3 continues on growth path via bid for rest of MTI shares A Medical Device Daily Staff Report Following an aggressive growth path in interventional cardiology – and rivaling that of acquisition-minded Boston Scientific (Natick,...

Report from Europe.
October 12, 2005... Report from Europe Welsh bioscience growth: from chemiluminescence to maggots By AARON LORENZO Medical Device Daily Washington Writer CARDIFF, Wales – Life science research is alive and well in Wales, the UK country...

Deals roundup.
October 12, 2005... Deals roundup Accellent, KKR in $1.3B merger; GHX in $200M buy of Neoforma A Medical Device Daily Staff Report Accellent (Wilmington, Massachusetts), which calls itself the largest provider of integrated contract manufacturing and...

Court report.
October 12, 2005... Court report EP MedSystems terminates CEO over Iran sales/reports A Medical Device Daily Staff Report EP MedSystems (West Berlin, New Jersey) reported Monday that its board of directors had terminated Reinhard Schmidt as CEO,...

Financings roundup.(N Spine financing from Life Science Angels)(Yulex closes funding round)(LabConnect signs agreement with Consolidated Laboratory Services)
October 12, 2005... Financings roundup N Spine receives $415K from angel group in its 'A' round A Medical Device Daily Staff Report Life Science Angels (LSA; Palo Alto, California), an investment group focused exclusively on early-stage medical device...

Grants/contracts.
October 12, 2005... Grants/contracts GE Global Research, hospital share $6.5M grant from NCI A Medical Device Daily Staff Report GE Global Research (Niskayuna, New York), the centralized research organization of General Electric (GE; Fairfield,...

ITN laboratory opens at Beckman facility.
October 12, 2005... ITN laboratory opens at Beckman facility Beckman Coulter (Fullerton, California) reported the opening of the Immune Tolerance Network (San Francisco) laboratory at the company's facility in Miami. The lab was established to develop,...

Briefly Noted.
October 12, 2005... Briefly Noted ASTRO launches radiation info web site The American Society for Therapeutic Radiology and Oncology (Fairfax, Virginia) reported the launch of its patient web site located at www.rtanswers.org. The site is dedicated to...

People in Places.(Chris Toal senior vice president at Amplifon USA)(Mark Hurtt chief medical officer at Boston Life Sciences)(Brian Ferrand joins BSD Medical)(David Harding senior vice president of Cytyc)
October 12, 2005... People in Places Chris Toal has been named senior vice president of marketing at Amplifon USA (Minneapolis). Toal previously served as vice president of marketing for Caribou Coffee. Amplifon said its Miracle-Ear, National Hearing Centers...

CyberKnife to be used in Miami prostate cancer trial.
October 12, 2005... CyberKnife to be used in Miami prostate cancer trial A Medical Device Daily Staff Report The CyberKnife Center of Miami (Miami) reported plans for a prostate cancer trial this year using CyberKnife technology. CyberKnife, manufactured...

Product Briefs.
October 12, 2005... Product Briefs • Grant Life Sciences (Murray, Utah), which develops products to improve the efficiency of detecting and diagnosing cervical cancer, said it was recently awarded a patent for essential components of its technology for...