Medical Device Week articles from May 2007

Medical Device Week archives from May 2007

Deals roundup.
May 22, 2007... Deals roundup Hologic, Cytyc create 'leader' in women's health via $6.2B merger By AMANDA PEDERSEN Medical Device Daily Staff Writer Between Hologic's (Bedford, Massachusetts) focus on breast cancer diagnostics and Cytyc's...

A code of conduct must be part of company 'culture,' not 'static'.
May 22, 2007... MDMA annual meeting A code of conduct must be part of company 'culture,' not 'static' By KAREN YOUNG Medical Device Daily Staff Writer WASHINGTON -- Although the word was never actually spoken, one of the second-day themes of...

International report.
May 22, 2007... International report EDAP, China Medical accord covers European distribution A Medical Device Daily Staff Report China Medical Technologies (Beijing), a maker of in vitro diagnostic systems and high-intensity focused ultrasound...

Studies look to biomarkers for non-alcoholic fatty liver disease.
May 22, 2007... Digestive Disease Week Studies look to biomarkers for non-alcoholic fatty liver disease KAREN YOUNG Medical Device Daily Staff Writer WASHINGTON -- Digestive Disease Week kicked off on Saturday at the Washington Convention...

Thermo, Quintiles create Cenduit to offer IRT to drug development.(Interactive Response Technology)(Thermo Fisher Scientific, Quintiles Transnational Corp.)
May 22, 2007... New ventures Thermo, Quintiles create Cenduit to offer IRT to drug development By AMANDA PEDERSEN Medical Device Daily Staff Writer Thermo Fisher Scientific (Waltham, Massachusetts) and Quintiles Transnational (Research...

Court report.
May 22, 2007... Court report Immucor insurance to pay $2.5M to settle financial 'inflation' suit A Medical Device Daily Staff Report Immucor (Norcross, Georgia), a developer of automated instrument-reagent systems for the blood transfusion...

Financings roundup.
May 22, 2007... Financings roundup Cambridge Heart in share resale; Axis Three gathers new funding A Medical Device Daily Staff Report As outlined in an earlier report to the Securities and Exchange Commission, Cambridge Heart (Bedford,...

Agreements roundup.(Clinical report)
May 22, 2007... Agreements roundup Biomet in research accord with Massachusetts General Hospital A Medical Device Daily Staff Report Biomet (Warsaw, Indiana) reported that its orthopedics unit has formed a strategic research alliance with...

People in Places.
May 22, 2007... People in Places * John George has been named senior VP of sales for A.D.A.M. (Atlanta). George most recently was senior VP of sales for Per-Se Technologies, a healthcare software firm acquired by McKesson Corporation in January....

Product Briefs.
May 22, 2007... Product Briefs * fsPhysioMed (Aliso Viejo, California) said that its mechanical penile traction device, the Extender, has been demonstrated to produce 10-45 degree improvements in Peyronie's curvatures for study patients. The device also...

Capitol Hill veteran Cohen to lead federal advocacy for AdvaMed.(Julie Cohen)(Brief article)
May 22, 2007... Capitol Hill veteran Cohen to lead federal advocacy for AdvaMed A Medical Device Daily Staff Report AdvaMed (Washington) yesterday reported the appointment of Julie Cohen, a Capitol Hill veteran and former staff director of the Senate...

Big dollars, with increasing risk, driving new "lifestyle" medicine.(medical technology market)
May 23, 2007... IBF MedTech Investing Conference Big dollars, with increasing risk, driving new 'lifestyle' medicine By DIANA TUCKER Medical Device Daily Contributing Writer MINNEAPOLIS -- The largest amount ever -- $2.7 billion -- was...

8,800-patient trial pits Medtronic's Endeavor against J&J's Cypher.
May 23, 2007... 8,800-patient trial pits Medtronic's Endeavor against J&J's Cypher By AMANDA PEDERSEN Medical Device Daily Staff Writer For the past year drug-eluting stents (DES) have raised concerns about blood clots, damaging sales of...

Report form Europe.
May 23, 2007... Report form Europe EU, U.S. meet to "break the ice" for cooperation in e-health By JOHN BROSKY Medical Device Daily European Correspondent At the first-ever workshop for electronic health records (EHR) collaboration between...

Invendo Medical poster session: a colonoscopy that's.
May 23, 2007... Digestive Disease Week Invendo Medical poster session: a colonoscopy that's 'painless' By KAREN YOUNG Medical Device Daily Staff Writer Research Professor Thomas Rösch, MD, will present data today at Digestive Disease...

Financings roundup.
May 23, 2007... Financings roundup Power Medical Interventions files for IPO to raise up to $100 million A Medical Device Daily Staff Report Power Medical Interventions (PMI; Langhorne, Pennsylvania) has filed a registration statement with the...

Patent watch.
May 23, 2007... Patent watch Based on study findings in India, Aethlon to file for U.S. patents A Medical Device Daily Staff Report Aethlon Medical (San Diego) reported that researchers at India's National Institute of Virology (NIV; Puhn) have...

Deals roundup.
May 23, 2007... Deals roundup IsoTis gets $2.5M via expanded pact with supplier, AlloSource A Medical Device Daily Staff Report IsoTis (Irvine, California) reported that it has expanded its existing private label agreement with AlloSource...

Study: HemoCue microalbumin test as good as laboratory test.
May 23, 2007... Conference notes Study: HemoCue microalbumin test as good as laboratory test A Medical Device Daily Staff Report A study presented at the American Society of Hypertension (ASH; New York) 22nd Annual Scientific Meeting and...

Product Briefs.
May 23, 2007... Product Briefs * Aesthera (Pleasanton, California) reported commercial introduction of a new painless laser therapy -- Isolaz (deep pore laser therapy). Powered by photopneumatic technology, the Isolaz helps destroy acne-causing bacteria...

People in Places.
May 23, 2007... People in Places * Eugene Jennings was named president/CEO of etrials Worldwide (Morrisville, North Carolina), replacing CEO John Cline who has resigned his position to pursue other interests but remains as a member of the board. Jennings...

FoxHollow to pursue IDE for NightHawk rather than 510(k).
May 23, 2007... FoxHollow to pursue IDE for NightHawk rather than 510(k) A Medical Device Daily Staff Report FoxHollow Technologies (Redwood City, California) reported plans to conduct a clinical study of its NightHawk Plaque Excision System under an...

Cryoablation gains momentum for prostate cancer therapy.
May 24, 2007... American Urological Association Annual Meeting Cryoablation gains momentum for prostate cancer therapy By LARRY HAIMOVITCH Medical Device Daily Contributing Writer ANAHEIM -- The annual gathering of the American Urological...

Phase Forward offering at $90M; Genomic Health raises $45 million.
May 24, 2007... Phase Forward offering at $90M; Genomic Health raises $45 million By JIM SHRINE Medical Device Daily Staff Writer And MDD Staff Reports Phase Forward (Waltham, Massachusetts), a provider of data management solutions for...

Report from Europe.
May 24, 2007... Report from Europe St. Jude receives CE marks for wireless devices and EnSight A Medical Device Daily Staff Report St. Jude Medical (St. Paul, Minnesota) reported European CE-mark approval of its first wireless devices to treat...

Financings roundup.
May 24, 2007... Financings roundup Amedica files for $75 million IPO; AM offer to raise more than $163M A Medical Device Daily Staff Report Amedica (Salt Lake City) reported that it has filed a statement with the Securities and Exchange...

Deals roundup.
May 24, 2007... Deals roundup Harvard licenses CARS system to Carl Zeiss MicroImaging A Medical Device Daily Staff Report Harvard University (Cambridge, Massachusetts) reported that it has licensed its Coherent anti-Stokes Raman scattering (CARS)...

EDAP says interest will push "fast-tracking" of its U.S. trial.
May 24, 2007... AUA notebook EDAP says interest will push 'fast-tracking' of its U.S. trial A Medical Device Daily Staff Report EDAP (Lyon, France) said it is "fast-tracking" its ongoing U.S. Ablatherm-HIFU clinical trial. According to the...

Agreements roundup.
May 24, 2007... Agreements roundup Digital Angel, VeriChip to work on implantable glucose microchip A Medical Device Daily Staff Report Digital Angel (South St. Paul, Minnesota), focused on the field of identification, location tracking and...

Briefly Noted.
May 24, 2007... Briefly Noted Innovative Biosensors reclocates Innovative Biosensors (Rockville, Maryland), makers of ultra-sensitive tests to detect harmful pathogens for both the clinical and biodefense markets, said that it has graduated from the...

New SBA guidelines result in shut-down of Iris's ADIR unit.
May 24, 2007... New SBA guidelines result in shut-down of Iris's ADIR unit A Medical Device Daily Staff Report Iris International (Chatsworth, California) reported yesterday that it plans to close the operations of its wholly owned Advanced Digital...

Court report.
May 24, 2007... Court report AzHHA settles with DOJ, Arizona over uniform billing allegations A Medical Device Daily Staff Report The Department of Justice (DOJ) and the State of Arizona reported reaching a settlement with the Arizona Hospital and...

Product Briefs.
May 24, 2007... Product Briefs * Aspect Medical Systems (Norwood, Massachusetts) reported interim study results from the Biomarkers for Rapid Identification of Treatment Effectiveness (BRITE) trial in major depression will be presented this week at the...

FDA orthopedic panel to review 2nd Medtronic disc arthroplasty system.(Brief article)
May 24, 2007... FDA orthopedic panel to review 2nd Medtronic disc arthroplasty system A Medical Device Daily Staff Report Medtronic Spinal and Biologics (Memphis, Tennessee) reported that its Bryan cervical disc system will be reviewed by the FDA...

Holiday notice.
May 25, 2007... Holiday notice The offices of Medical Device Daily will be closed Monday, May 28, due to the Memorial Day holiday in the U.S., and no issue will be published that day. The next issue will be on Tuesday, May 29. SOURCE-Medical Device...

Deals roundup.
May 25, 2007... Deals roundup AMO indicates interest in topping Warburg's $3.67B offer for B&L By HOLLAND JOHNSON Medical Device Daily Managing Editor In what may be shaping up to be still another auction battle in the med-tech sector,...

J&J bolsters cardio offerings to offset its setbacks in DES.
May 25, 2007... EuroPCR J&J bolsters cardio offerings to offset its setbacks in DES By JOHN BROSKY Medical Device Daily European Correspondent BARCELONA -- Two weeks after reporting dismal results against a key competitor in clinical trials...

International report.
May 25, 2007... International report Pluristem buys stem cell tech from Technion-Israel for $2M A Medical Device Daily Staff Report Pluristem Life Systems (New York), a developer of products to treat degenerative and auto-immune indications,...

Physicians seek better tools to diagnose, treat colon cancer.
May 25, 2007... Digestive Disease Week 2007 Physicians seek better tools to diagnose, treat colon cancer By MARK McCARTY Medical Device Daily Washington Editor WASHINGTON -- The prevalence of colon cancer has become more conspicuous on the...

Financings roundup.
May 25, 2007... Financings roundup Helicos again lowers IPO price; AtriCure in private $16.5M offer A Medical Device Daily Staff Report Helicos BioSciences (Cambridge, Massachusetts), the developer of a system for genetic analysis, has lowered the...

FDA wants 'black box' warnings for certain MRI contrast agents.
May 25, 2007... FDA wants 'black box' warnings for certain MRI contrast agents A Medical Device Daily Staff Report The FDA is asking manufacturers to include a new boxed warning, also known as a "black box" warning, on the product labeling of all...

Court report.
May 25, 2007... Court report Former OrthoClear patients sue Align alleging contract breach A Medical Device Daily Staff Writer Align Technology (Santa Clara, California), inventor of Invisalign, a method of straightening teeth without wires or...

Boston Sci reports CE mark for Taxus Liberté Long at EuroPCR.
May 25, 2007... EuroPCR notebook Boston Sci reports CE mark for Taxus Liberté Long at EuroPCR A Medical Device Daily Staff Report Boston Scientific (Natick, Massachusetts) reported at the EuroPCR meeting, winding down today in Barcelona,...

Cordis Europe thinks out-of-the-box.(Cordis Europa N.V.)
May 25, 2007... EuroPCR notes Cordis Europe thinks out-of-the-box Far from pulling in its horns after the CoStar II setback to its stent portfolio, Cordis for Europe, the Middle East and Africa (Cordis EMEA ; Brussels) agressively launched a new...

Briefly Noted.
May 25, 2007... Briefly Noted Lasik refunds raise eyebrows The practice of money back plans for medical eye care has raised concerns with the Council for Refractive Surgery Quality Assurance (USAEyes.org; Sacramento, California), a non-profit patient...

Product Briefs.
May 25, 2007... Product Briefs * Abbott (Des Plaines, Illinois) and Celera (Rockville, Maryland), an Applera business, reported that Abbott has received FDA approval to market the Abbott RealTime HIV-1 viral load test for use on the company's m2000...

People in Places.
May 25, 2007... People in Places * Delcath Systems (Stamford, Connecticut) named Jonathan Foltz, CFA, to the newly created position of executive VP. Foltz has been working with Delcath in an advisory position since February. Prior to returning to...

'Virtual' CTC gets yes/no review in comparison to colonoscopy.(computerized tomographic colonoscopy )(Clinical report)
May 29, 2007... Digestive Disease Week 'Virtual' CTC gets yes/no review in comparison to colonoscopy By MARK McCARTY Medical Device Daily Washington Editor WASHINGTON -- The last day of the 2007 edition of Digestive Disease Week included a...

MIS need for OSA therapy fuels strong response to Aspire trial.
May 29, 2007... MIS need for OSA therapy fuels strong response to Aspire trial By AMANDA PEDERSEN Medical Device Daily Staff Writer When a news station in Indiana, WTHR Indianapolis, recently aired a brief segment about a new procedure from Aspire...

Advances in Diagnostics & Imaging available now.
May 29, 2007... Advances in Diagnostics & Imaging available now The latest version of Medical Device Daily's overview of the clinical diagnostics and diagnostic imaging sector, Advances in Diagnostics & Imaging, Vol. 2, is now available. The book,...

Report from Europe.
May 29, 2007... Report from Europe Amsterdam pilot RFID project analyzes tech at 'bleeding edge' By JOHN BROSKY Medical Device Daily Contributing Writer PARIS -- Can radio frequency identification technology (RFID) become for hospitals what...

Washington roundup.
May 29, 2007... Washington roundup Common Good, others boost bills supporting health courts A Medical Device Daily Staff Report Common Good (Washington), a legal reform coalition, said that identical bipartisan bills that advance an idea developed...

Financings roundup.(Vasogen Inc. reports financial results)(Inovio Biomedical Corp. raises money from market)
May 29, 2007... Financings roundup Inovio raises private $16.17M; Vasogen placement nets $14.6M A Medical Device Daily Staff Report Inovio Biomedical (San Diego), focused on the development of DNA-based vaccines for cancers and infectious...

Briefly Noted.
May 29, 2007... Briefly Noted Smiths Medical, MD gets ACHC accrediation Smiths Medical, MD (Saint Paul, Minnesota), part of the Smiths Group, reports its award of accreditation status by the Accreditation Commission for Health Care (ACHC) for medical...

Deals roundup.
May 29, 2007... Deals roundup UHS prices its cash tender offer; Health Care REIT buys 17 MOBs A Medical Device Daily Staff Report Universal Hospital Services (UHS; Edina, Minnesota) has priced its cash tender offer to purchase any and all of its...

Agreements roundup.(Swearingen Software partnership with Connect Imaging)(BioElectronics in distribution agreement with Eximeq)
May 29, 2007... Agreements roundup Swearingen, Connect join to offer integrated RIS/PACS solutions A Medical Device Daily Staff Report Swearingen Software (Houston) a developer of radiology information systems (RIS), reported a partnership with...

Medtronic presents positive long-term Endeavor DES data.
May 29, 2007... EuroPCR notebook Medtronic presents positive long-term Endeavor DES data A Medical Device Daily Staff Report Medtronic (Minneapolis) presented new long-term data from the ENDEAVOR clinical trial program at the EuroPCR meeting...

People in Places.(SensiGen appoints Jay Stoerker)(Dan Ciaburri appointed at Kinetic Concepts Inc.)(Cambridge Heart Inc. promotes Vincenzo LiCausi )(Brief article)
May 29, 2007... People in Places * Vincenzo LiCausi has been promoted to VP of finance of Cambridge Heart (Bedford, Massachusetts). LiCausi replaces Roderick de Greef, who earlier this year notified the company of his intention to resign. Prior to...

Cardiologist James Holsinger is Bush surgeon general nominee.(George W. Bush selects candidate for Public Health Serivce)(Brief article)
May 29, 2007... Cardiologist James Holsinger is Bush surgeon general nominee A Medical Device Daily Staff Report President Bush has picked Kentucky cardiologist James Holsinger Jr. as the 18th surgeon general to oversee the U.S. Public Health Serivce....

Product Briefs.(DePuy Spine launches Vertigraft VG2)(GE Healthcare gains FDA approval for Carescape mobile patient monitoring)(Roche Diagnostics changes to CoaguChek PT strips)
May 29, 2007... Product Briefs * DePuy Spine (Raynham, Massachusetts) reported launch of the Vertigraft VG2 TLIF allograft, a new bone product designed to facilitate graft insertion and bone growth during transforaminal lumbar spinal fusion (TLIF)...

AMO in voluntary global recall of Moisture Plus contact lens solution.(American Hospital Supply Corp. American Medical Optics)
May 30, 2007... AMO in voluntary global recall of Moisture Plus contact lens solution By HOLLAND JOHNSON Medical Device Daily Managing Editor In the wake of voluntary global recall issued late last week related to one of its contact lens...

"No scar left behind" is a major benefit of NOTES procedure.(Natural Orifice Translumenal Endoscopic Surgery)
May 30, 2007... Digestive Disease Week 'No scar left behind' is a major benefit of NOTES procedure By DIANA TUCKER Medical Device Daily Contributing Writer WASHINGTON -- As was the case last year at the Digestive Disease Week meeting, NOTES...

Report from Europe.
May 30, 2007... Report from Europe Position sensor boosts 'hold' on images for functional MRI By JOHN BROSKY Medical Device Daily Contributing Writer And MDD Staff Reports Researchers at the Fraunhofer Institut fur Graphische...

Financings roundup.(Company overview)
May 30, 2007... Financings roundup EnteroMedics in IPO to push RF system to 'turn off' hunger By DON LONG Medical Device Daily Executive Editor And MDD Staff Reports EnteroMedics (St. Paul, Minnesota) reported filing a statement with...

Court report.
May 30, 2007... Court report Floridians settle insider trading charges in buy of Serologicals A Medical Device Daily Staff Report The Securities and Exchange Commission has filed an action against Raymond Chop and Nicholas Chop, residents of...

Deals roundup.(454 Life Sciences acquired by Roche Holding Ltd.)(Inverness Medical Innovations Inc. acquires Biosite)
May 30, 2007... Deals roundup IMI begins Biosite share tender; Roche completes its 454 buy A Medical Device Daily Staff Report Inverness Medical Innovations (IMI; Waltham, Massachusetts) reported that its wholly owned subsidiary, Inca Acquisition,...

Patent watch.
May 30, 2007... Patent watch U.S. notice of allowance for skin cholesterol test won by PreMD A Medical Device Daily Staff Report Predictive medicine company PreMD (Toronto) reported that the U.S. Patent and Trademark Office has issued a Notice of...

Abbott in recall of Architect STAT Troponin-I diagnostic test.
May 30, 2007... Abbott in recall of Architect STAT Troponin-I diagnostic test A Medical Device Daily Staff Report Abbott Laboratories (Abbott Park, Illinois) reported that it has initiated a voluntary, nationwide recall of its Architect STAT...

Major June med-tech meetings.(Calendar)
May 30, 2007... Major June med-tech meetings * American Society of Clinical Oncology 43rd annual meeting, June 1-5 McCormick Place, Chicago, Illinois http://www.asco.org/portal/site/ASCO * NIH symposium: "Changing the World's Healthcare...

Product Briefs.(two new assays from Haemoscope)(minimal access retractor system from Globus Medical)(reducing malignant lesions with ArthroCare Corp.)
May 30, 2007... Product Briefs * ArthroCare (Austin, Texas) said it has received FDA clearance for its cavity SpineWand to reduce malignant lesions within the vertebrae, via a minimally invasive, surgical procedure to remove malignant tissue within...

People in Places.(Bruce DeChambre appointed at Draxis Health Inc.)(Brief article)
May 30, 2007... People in Places * Bruce DeChambre has been named VP of commercial and business development for DRAXIS Pharma (Mississauga Ontario). Previously, DeChambre was VP of sales and marketing at SAB-Pharma, the U.S. marketing arm of Sabex....

Deals roundup.
May 31, 2007... Deals roundup ISS recommends shareholders should reject $10.9 Biomet deal By HOLLAND JOHNSON Medical Device Daily Managing Editor The well-known shareholder advisory firm Institutional Shareholder Services (ISS; Rockville,...

Prize-winning Robopsy poised for lung biopsy improvement.(Massachusetts Institute of Technology )
May 31, 2007... Prize-winning Robopsy poised for lung biopsy improvement By ROB KIMBALL Medical Device Daily Staff Writer Certainly, it's a large understatement to describe the standard lung cancer biopsy as inconvenient, not particularly...

Report from Europe.
May 31, 2007... Report from Europe Sanuwave receives CE mark for dermaPACE wound-care device A Medical Device Daily Staff Report Sanuwave (Alpharetta, Georgia), a developer of extracorporeal shock wave technology (ESWT) and pulsed acoustic...

Cedara offering software that automates orthopedic plans.
May 31, 2007... Cedara offering software that automates orthopedic plans By KAREN YOUNG Medical Device Daily Staff Writer As the population ages, more and more people in the Baby Boomer generation are utilizing orthopedic surgery to keep their...

Court report.(Beverly Rockwell vs. Bayer HealthCare AG)
May 31, 2007... Court report New lawsuits begin to add up alleging imaging agent injuries A Medical Device Daily Staff Report The mother of a 24-year-old Norwalk, Ohio, man who died in 2004, shortly after receiving his second injection of the drug...

Financings roundup.
May 31, 2007... Financings roundup IHS files chapter 11 bankruptcy; IsoTis adds $20M credit facility A Medical Device Daily Staff Report InSight Health Services Holdings (IHS; Lake Forest, California) reported that it and its wholly owned...

FDA roundup.
May 31, 2007... FDA roundup FDA, PTO still sorting out 1998 extension request for patent By MARK McCARTY Medical Device Daily Washington Editor FDA has issued a Federal Register notice that it has determined the regulatory review time for a...

Contracts.
May 31, 2007... Contracts Reflect Scientific subsidiary awarded contract in GPS biz A Medical Device Daily Staff Report Reflect Scientific (Orem, Utah), a manufacturer of scientific equipment and related supplies, reported that Image Labs...

New ventures.
May 31, 2007... New ventures Lesanne formed to develop blood test to detect occurrence of stroke A Medical Device Daily Staff Report The Channel Group (New York) said it has formed Lesanne Life Sciences (Ivoryton, Connecticut), a diagnostic...

Product Briefs.(new medical imaging from Perceptive Informatics Inc.)(data management software from Home Diagnostics Inc.)(high-energy beam processing from Ebtec Corp.)
May 31, 2007... Product Briefs * EBTEC (Agawam, Masssachusetts), a developer of high-energy beam processing and manufacturing services, unveiled what it called its newest technological advance -- Surfi-Sculpt -- an electron beam process that can modify...

People in Places.
May 31, 2007... People in Places * Jim Hinrichs has been promoted from senior VP and CFO to executive VP and controller, and Stuart Laws has been promoted from VP, accounting and reporting, to VP and chief accounting officer of Cardinal Health (Dublin,...