Medical Device Week articles from July 2006

Medical Device Week archives from July 2006

Deals roundup.
July 5, 2006... Deals roundup Siemens eying No. 2 in sector via $5.3B Bayer Diag unit buy By DON LONG Medical Device Daily Managing Editor The diagnostics sector has two levels -- a handful of Goliaths in one group, a multitude of Davids in...

New FDA guidances aimed at reducing 'gridlock' of trials.
July 5, 2006... New FDA guidances aimed at reducing 'gridlock' of trials By MARK McCARTY Medical Device Daily Washington Editor The FDA last week released another clutch of guidances under the Critical Path Initiative, with the goal to push...

International report.
July 5, 2006... International report Canada clears Pall's system for platelet bacterial test A Medical Device Daily Staff Report Pall (East Hills, New York) said that Health Canada granted it clearance to market the Acrodose PL System. The new...

Company to take $70M 2Q charge.
July 5, 2006... Company to take $70M 2Q charge Baxter must correct quality to renew pump manufacturing A Medical Device Daily Staff Report The FDA reported last week that Baxter Healthcare (Deerfield, Illinois) and two top executives have signed a...

Court report.
July 5, 2006... Court report Scrushy is guilty of bribery to buy seat on medical board A Medical Device Daily Staff Report Richard Scrushy, former CEO of HealthSouth (Birmingham, Alabama), last week was found guilty -- along with former Alabama...

Briefly Noted.
July 5, 2006... Briefly Noted Conceptus named to Russell 3000 Conceptus (San Carlos, California), developer of the non-incisional Essure permanent birth control procedure, reported that the company has been added to the Russell 3000 Index following...

Financings roundup.
July 5, 2006... Financings roundup Cytyc gets $150M credit facility; Systems Xcellence adds $38.7M A Medical Device Daily Staff Report Cytyc (Marlborough, Massachusetts) reported entering into a five-year multicurrency credit agreement providing...

Agreements roundup.
July 5, 2006... Agreements roundup SurModics, AbbeyMoor in pact to develop prostate stents A Medical Device Daily Staff Report SurModics (Eden Prairie, Minnesota), a provider of surface modification technologies in the areas of biocompatibility,...

Wiley building and namesake honored in 100th observance.
July 5, 2006... Wiley building and namesake honored in 100th observance A Medical Device Daily Staff Report The FDA celebrated the 100th anniversary of the Pure Food and Drugs Act of 1906 last Friday in an event featuring Health and Human Services...

Possis on Nasdaq Global Select.
July 5, 2006... Possis on Nasdaq Global Select Possis Medical (Minneapolis) said that it is included in the new Nasdaq Global Select Market. The Nasdaq Global Select Market has the highest initial listing standards of any exchange in the world based on...

Product Briefs.
July 5, 2006... Product Briefs * Aastrom Biosciences (Ann Arbor, Michigan) said that it has completed the last patient accrual and treatment in its U.S. Phase I/II multi-center long-bone fracture trial. Completion of the cell therapy phase for all 36...

1st patient with WorldHeart rotary VAD seen recovering.
July 5, 2006... 1st patient with WorldHeart rotary VAD seen recovering A Medical Device Daily Staff Report WorldHeart (Oakland, California), a developer of mechanical circulatory support systems, reported that the first patient implanted with its...

People in Places.
July 5, 2006... People in Places * Carol Atwood has been named as the new administrator for Cirrus Health's (Trophy Club, Texas) Spring Creek Surgery Center (Tomball, Texas). She will oversee all operations of the ambulatory surgery center that opened in...

Deals roundup.
July 6, 2006... Deals roundup Encore Medical going private via agreement with Blackstone A Medical Device Daily Staff Report Orthopedic products manufacturer Encore Medical (Austin, Texas) said late last week that it had entered into a definitive...

Moratorium on Medicare cuts for imaging eyed in H.R. 5704.
July 6, 2006... Moratorium on Medicare cuts for imaging eyed in H.R. 5704 By MARK McCARTY Medical Device Daily Washington Editor WASHINGTON -- While healthcare information technology has commanded much of the healthcare attention on Capitol Hill,...

Report from Europe.
July 6, 2006... Report from Europe Gilde Healthcare reports 1st closing of new fund at $107M A Medical Device Daily Staff Report Gilde Healthcare Partners (Utrecht, the Netherlands), a life sciences venture capital group, has reported the first...

Genentech's Lucentis gets FDA approval for wet AMD.
July 6, 2006... Genentech's Lucentis gets FDA approval for wet AMD By AARON LORENZO Medical Device Daily Washington Writer To no one's surprise, Genentech's (South San Francisco, California) Lucentis received FDA approval late last week for...

Financings roundup.
July 6, 2006... Financings roundup NovaMed boosts credit to $80M; Tutogen gets private $3 million A Medical Device Daily Staff Report NovaMed (Chicago) reported that it has entered into an amendment to its credit facility that increases the size...

Grants/contracts.
July 6, 2006... Grants/contracts Biophan gets $1M in federal funding for cardiac support A Medical Device Daily Staff Report Biophan Technologies (West Henrietta, New York), a company with the goal of making all biomedical devices capable of...

Court report.
July 6, 2006... Court report Applera and Beckman Coulter resolve their legal disputes A Medical Device Daily Staff Report Applera (Norwalk, Connecticut) and Beckman Coulter (Fullerton, California), a maker of instrument systems, tests and supplies...

Briefly Noted.
July 6, 2006... Briefly Noted Cigna to cover Cambridge Heart's MTWA test Cambridge Heart (Bedford, Massachusetts) said that Cigna HealthCare, a provider of healthcare benefits covering more than 12 million Americans, has revised its coverage position...

People in Places.
July 6, 2006... People in Places * Christopher Cella has joined eNotes Systems (Los Angeles) as senior vice president of legal affairs and corporate development. Cella had previously served as vice president, general counsel and corporate secretary of...

Product Briefs.
July 6, 2006... Product Briefs * Carstone Seating (Somerset, Kentucky), a provider of seating solutions for healthcare, institutional and hospitality facilities, said it unveiled its new 51100 series bariatric chair at the 23rd annual meeting of the...

Ciphergen subject to Nasdaq delisting.
July 6, 2006... Ciphergen subject to Nasdaq delisting Ciphergen Biosystems (Fremont, California), which is focused on translating protein biomarkers and panels of biomarkers into protein molecular diagnostic tests that improve patient care, said that the...

New Report Provides Analysis on Biodefense Sector Growth <!DOCTYPE HTML PUBLIC "-//W3C//DTD HTML 4.0 Transitional//EN"> <!-- saved from url=(0069)http://66.45.31.10/servlet/com.accumedia.web.Dispatcher?next=calendar --> <HTML><HEAD>.(Biodefense Market Report 2006: Vaccines, Therapeutics)
July 6, 2006... Biodefense Market Report 2006: Vaccines, Therapeutics and Diagnostics for Bioterror Agents *237 pages 15% larger than 2005 edition. *Expanded profiles of products for SARS *Current products in development for avian...

Zimmer gets FDA approval for ceramic hip replacement sale.
July 7, 2006... Zimmer gets FDA approval for ceramic hip replacement sale By HOLLAND JOHNSON Medical Device Daily Associate Managing Editor Zimmer Holdings (Warsaw, Indiana) reported that it has received approval of its premarket approval (PMA)...

Symphony Medical begins trial in Europe for AF treatment.
July 7, 2006... Symphony Medical begins trial in Europe for AF treatment By KAREN YOUNG Medical Device Daily Staff Writer Symphony Medical (Laguna Hills, California) said it is starting patient enrollment in a Phase II multicenter trial of its...

Report from Israel.
July 7, 2006... Report from Israel Given Imaging seen through rearview mirror of ex-CEO By RAE FISHMAN Medical Device Daily Contributing Writer ZICHRON YAAKOV, Israel &ndash; Moving on: Gavriel Meron, founder, longtime CEO, president, member...

Medtronic InterStim II system for overactive bladder OK'd.
July 7, 2006... Medtronic InterStim II system for overactive bladder OK'd By HOLLAND JOHNSON Medical Device Daily Associate Managing Editor Medtronic (Minneapolis) reported that the FDA has approved the company's InterStim II system for the...

Merge Healthcare CEO, others out in wake of investigation.
July 7, 2006... Merge Healthcare CEO, others out in wake of investigation A Medical Device Daily Staff Report Merge Technologies (d/b/a Merge Healthcare; Milwaukee) provided an update earlier this week on the status of the previously disclosed...

Deals roundup.(Company overview)
July 7, 2006... Deals roundup RehabCare Group grows with purchase of Symphony Health A Medical Device Daily Staff Report RehabCare Group (St. Louis) reported completing its acquisition of Symphony Health Services (Hunt Valley, Maryland) and its...

Financings roundup.
July 7, 2006... Financings roundup Boston Sci converts $15M in Corautus notes into equity A Medical Device Daily Staff Report Corautus Genetics (Atlanta), developing gene therapy products for the treatment of cardiovascular (severe angina) and...

Grants/contracts.
July 7, 2006... Grants/contracts HHS reports $15M collaboration with The Atlantic Philanthropies A Medical Device Daily Staff Report Health and Human Services (HHS; Washington) Secretary Mike Leavitt reported a $15 million collaboration with the...

Briefly Noted.
July 7, 2006... Briefly Noted Initial standards identified for EHRs The Healthcare Information Technology Standards Panel (HITSP) has identified for the U.S. Department of Health and Human Services an initial set of standards to facilitate the secure...

People in Places.
July 7, 2006... People in Places &bull; James William Poser, PhD, has been named vice president research and development and chief technology officer of IsoTis OrthoBiologics (Lausanne, Switzerland/Irvine, California). Poser, who also is a member of the...

Product Briefs.
July 7, 2006... Product Briefs &bull; CAS Medical Systems (Bransford, Connecticut), which is focused on noninvasive vital signs monitoring, reported that it has been awarded two U.S. patents for technology used in its Fore-Sight Cerebral Oximeter,...

Panel: U.S. universal coverage will come with less med-tech.
July 10, 2006... Panel: U.S. universal coverage will come with less med-tech By MARK McCARTY Medical Device Daily Washington Editor WASHINGTON -- If universal healthcare coverage is adopted by the U.S., it probably will come with a price:...

Valera seeking approval for annual implant to fight CPP.
July 10, 2006... Valera seeking approval for annual implant to fight CPP By AARON LORENZO Medical Device Daily Washington Writer Valera Pharmaceuticals (Cranbury, New Jersey) has filed for FDA approval of Supprelin-LA, a 12-month implant for a...

International report.
July 10, 2006... International report Medtronic's InSync III Marquis receives approvals in Japan A Medical Device Daily Staff Report In conjunction with the Japan Heart Rhythm Society annual meeting in Tokyo, Medtronic (Minneapolis) on Friday...

Independent Forensics offering genetic test for HIV resistance.
July 10, 2006... Independent Forensics offering genetic test for HIV resistance By KAREN YOUNG Medical Device Daily Staff Writer Independent Forensics (Hillside, Illinois), which says it is the "leading independent forensics laboratory" in the...

Deals roundup.
July 10, 2006... Deals roundup Primedex to acquire Radiologix via $208 million cash/stock deal A Medical Device Daily Staff Report Primedex Health Systems (Los Angeles) and Radiologix (Dallas) reported an agreement for Primedex to acquire...

Financings roundup.
July 10, 2006... Financings roundup Emerging Life Sciences Fund I is closed by Bailard at $40M A Medical Device Daily Staff Report Bailard (Foster City, California) reported final closing of its Emerging Life Sciences Fund I, with more than $40...

Court report.
July 10, 2006... Court report Nektar settles with university via $25 million in payments A Medical Device Daily Staff Report Nektar Therapeutics (San Carlos, California) and the University of Alabama in Huntsville (UAH) reported the settlement of...

Agreements roundup.
July 10, 2006... Agreements roundup Philips in pact with Dartmouth medical, engineering schools A Medical Device Daily Staff Report Philips Medical Systems (Andover, Massachusetts), a division of Royal Philips Electronics, and the medical and...

Briefly Noted.
July 10, 2006... Briefly Noted Lives saved by reducing medical errors A campaign to reduce lethal errors and unnecessary deaths in the nation's hospitals has saved an estimated 122,300 lives in the last 18 months, the campaign's leader said. "I think...

People in Places.
July 10, 2006... People in Places * Jeffrey Walker, MD, has joined Angiotech Pharmaceuticals (Vancouver, British Columbia) as senior vice president, research and development. Walker has more than 14 years' experience at pharmaceutical and medical device...

Product Briefs.
July 10, 2006... Product Briefs * Ample Medical (Foster City, California), which manufactures endovascular medical devices for repairing heart valves, reported the first human implants of its PS3 System. The successful implants, performed at University...

Internet seen as conduit for best-practices dissemination.
July 11, 2006... Internet seen as conduit for best-practices dissemination By MARK McCARTY Medical Device Daily Washington Editor BETHESDA, Maryland &ndash; Translating best practices into standard clinical practice is a notoriously difficult...

Deals roundup.
July 11, 2006... Deals roundup Hologic settles FTC dispute, will sell SBBS to Siemens A Medical Device Daily Staff Report Hologic (Bedford, Massachusetts), a provider of diagnostic and digital imaging systems for women's health, reported that it...

Report from Europe.
July 11, 2006... Report from Europe Aradigm gives Novo Nordisk glucose control patent rights A Medical Device Daily Staff Report Delivering to Novo Nordisk (Bagsvaerd, Denmark) a key piece of the puzzle for its inhaled insulin system, Aradigm...

Restech device aids doctors in real-time reflux detection.
July 11, 2006... Restech device aids doctors in real-time reflux detection By KIM URQUHART Medical Device Daily Staff Writer Ross Tsukashima, director of product development at Restech (Respiratory Technology; San Diego), may sound like he is...

Washington roundup.
July 11, 2006... Washington roundup CMS withholds names of docs in study of ICD complications A Medical Device Daily Staff Report The Centers for Medicare & Medicaid Services (CMS; Baltimore) yesterday was expected to place on its web site data...

Financings roundup.
July 11, 2006... Financings roundup Moda receives $2.3 million to boost mobile computing effort A Medical Device Daily Staff Report Moda Technology Partners (Wayne, Pennsylvania) has received a $2.3 million investment, via purchase of stock, from...

Court report.
July 11, 2006... Court report Sharps, Attentus Medical in settlement, marketing accord A Medical Device Daily Staff Report Sharps Compliance (Houston) and subsidiaries, providers of medical waste disposal systems, reported the resolution of...

Agreements roundup.
July 11, 2006... Agreements roundup TGen, GE Healthcare allies in advanced genomic imaging A Medical Device Daily Staff Report The Translational Genomics Research Institute (TGen; Phoenix) and GE Healthcare (Waukesha, Wisconsin) have entered into...

Product Briefs.
July 11, 2006... Product Briefs &bull; FEI (Hillsboro, Oregon) reported the release of the V600FIB, a new focused ion beam (FIB) system designed to provide optimum flexibility for high-throughput applications including circuit modification,...

FDA to roll out 'track-and-trace' for drugs; devices may follow.
July 12, 2006... FDA to roll out 'track-and-trace' for drugs; devices may follow By MARK McCARTY Medical Device Daily Washington Editor WASHINGTON - The subject of drug supply chain security has drawn quite a bit of ink in recent months as...

S&N Endoscopy unit to acquire OsteoBiologics for $72.3 million.
July 12, 2006... S&N Endoscopy unit to acquire OsteoBiologics for $72.3 million A Medical Device Daily Staff Report The Endoscopy Division (Andover, Massachusetts) of Smith & Nephew (S&N; London) reported that it acqu-ired privately held OsteoBiologics...

Report from Europe.
July 12, 2006... Report from Europe UK okays [pounds sterling]750M to expand community hospital services A Medical Device Daily Staff Report A new generation of National Health Service (NHS) community hospitals has moved a big step closer to...

BioWorld releases new report on clinical trials industry.
July 12, 2006... BioWorld releases new report on clinical trials industry The publishers of Medical Device Daily's sister publication, BioWorld Today, have just released the new edition of the Clinical Trials State of the Industry Report 2006: Market...

Deals roundup.
July 12, 2006... Deals roundup Gilder purchases MedaSorb and closes $5.25M placement A Medical Device Daily Staff Report Gilder Enterprises (Monmouth Junction, New Jersey) reported completing the acquisition of MedaSorb (also Monmouth Junction) in...

Court Report.
July 12, 2006... Court report Alcon to pay AMO $121 million to settle disputes on 4 patents A Medical Device Daily Staff Report Advanced Medical Optics (AMO; Santa Ana, California) reported settling a dispute with Alcon, Alcon Manufactur-ing and...

Agreements roundup.
July 12, 2006... Agreements roundup Welch Allyn, Greenway sign software integration accord A Medical Device Daily Staff Report Welch Allyn (Skaneateles Falls, New York), a manufacturer of a broad range of medical products and solutions, said it has...

Financings roundup.
July 12, 2006... Financings roundup Avitar in $750K sale of notes; BioMag in $350,000 placement A Medical Device Daily Staff Report Avitar (Canton, Massachusetts) reported completing a financing with investors for the sale of $750,000 of secured...

Briefly Noted.
July 12, 2006... Briefly Noted AHCA pleased with nursing home report The American Health Care Association (AHCA; Wash- ington) said it is "pleased with the release" of new nursing home customer satisfaction data assessing care quality in America's...

Product Briefs.
July 12, 2006... Product Briefs * Kenneth Westbrook has been named president and appointed to the board of directors of flexSCAN (Mission Viejo, California). Westbrook brings more than 25 years of experience to the company, including serving as senior vice...

Cook granted PMA for Zilver stent to treat iliac arteries.
July 12, 2006... Cook granted PMA for Zilver stent to treat iliac arteries Cook (Bloomington, Indiana) has received FDA pre-market approval to market its Zilver Vascular Stent for use in treating symptomatic vascular disease of the iliac arteries. The...

SEC's Treadway group issues new small-cap SOX guidance.
July 13, 2006... SEC's Treadway group issues new small-cap SOX guidance By MARK McCARTY Medical Device Daily Washington Editor WASHINGTON &ndash; The Sarbanes-Oxley Act of 2002 (SOX) was roundly applauded in the financial press as promising more...

Minnesota study suggests AF incidence increasing rapidly.
July 13, 2006... Minnesota study suggests AF incidence increasing rapidly By KAREN YOUNG Medical Device Daily Staff Writer A community study conducted on atrial fibrillation (AF) with Minnesota patients, most of whom had received treatment at the...

Report from Israel.
July 13, 2006... Report from Israel Dune Medical eyes U.S. with breast cancer surgical probe By RAE FISHMAN Medical Device Daily Contributing Writer ZICHRON YAAKOV, Israel &ndash; Start-up Dune Medical Devices (Caesarea, Israel), which late...

FDA, HRS back Boston Sci's actions in defibrillator recall.
July 13, 2006... FDA, HRS back Boston Sci's actions in defibrillator recall By DON LONG Medical Device Daily Managing Editor In a clear attempt at public relations back-and-fill, Boston Scientific (Natick, Massachusetts) has garnered statements...

Court report.
July 13, 2006... Court report Odyssey to settle with feds via $13M, integrity agreement A Medical Device Daily Staff Report Odyssey HealthCare (Dallas), which calls itself the second-largest provider of hospice care in the U.S., reported entering...

Aksys eyeing litigation over supply agreement cancellation.
July 13, 2006... Aksys eyeing litigation over supply agreement cancellation In what may &ndash; or may not &ndash; be a dispute ending up in court, Aksys (Lincolnshire, Illinois), the troubled developer of home dialysis systems, yesterday said that it is...

Deals roundup.
July 13, 2006... Deals roundup Cardinal expands its patient safety line with MedMined buy A Medical Device Daily Staff Report Cardinal Health (Dublin) reported plans to acquire privately held MedMined, a developer of technology and services that...

Briefly Noted.
July 13, 2006... Briefly Noted Study addresses bone repair/tissue engineering The success of tissue engineering strategies for bone repair that involve injecting stem cells into biocompatible, 3-D fibrin matrices and then transplanting the scaffolds at...

Product Briefs.
July 13, 2006... Product Briefs &bull; Abiomed (Danvers, Massachusetts) reported FDA approval of its premarket approval supplement for the company's new integrated cannula system. The cannula has the potential for use off-pump with minimally invasive...

People in Places.
July 13, 2006... People in Places &bull; The American Diabetes Association (ADA; Alexandria, Virginia) appointed Katherine Rogers executive director for Central Maryland. Prior to joining the ADA, Rogers was senior director of communications and marketing...

Agreements roundup.(LXU Healthcare)(Society of Thoracic Surgeons)
July 13, 2006... Agreements roundup Guardian Technologies in pact with USC imaging laboratory A Medical Device Daily Staff Report Guardian Technologies International (Herndon, Virginia), a provider of security and healthcare solutions based on...

Cyberkinetics getting success, and ink, with BrainGate system.
July 14, 2006... Cyberkinetics getting success, and ink, with BrainGate system By DON LONG Medical Device Daily Managing Editor Mark down 2006 as the point in time when the phrase "I think, therefore I am," was significantly expanded - to "If all I...

Deals roundup.
July 14, 2006... Deals roundup Cordis acquires Ensure Medical; Hologic completes its buy of R2 A Medical Device Daily Staff Report Cordis (Miami Lakes, Florida), a business of Johnson & Johnson (New Brunswick, New Jersey), reported that that it has...

Report from Europe.
July 14, 2006... Report from Europe Metricath Gemini device gets CE-mark for two indications A Medical Device Daily Staff Report Medical Ventures (MEV; Richmond, British Columbia), a device company focused on products for the cardiovascular and...

Genoptix is second national lab to offer CellSearch test.
July 14, 2006... Genoptix is second national lab to offer CellSearch test By KAREN YOUNG Medical Device Daily Staff Writer Genoptix (Carlsbad, California), a provider of personalized medicine oncology services, has become only the second major...

Corautus says FDA lifts hold on its GENASIS angina trial.
July 14, 2006... Corautus says FDA lifts hold on its GENASIS angina trial A Medical Device Daily Staff Report Corautus Genetics (Atlanta) reported that the FDA has lifted the clinical hold imposed March 29 on the company's GENASIS (Genetic Angiogenic...

Financings roundup.
July 14, 2006... Financings roundup Radianse adds $6M 'B' round to support indoor positioning A Medical Device Daily Staff Report Radianse (Lawrence, Massachusetts), a provider of indoor positioning solutions (IPS) for healthcare, reported...