Medical Device Week articles from April 2005

Medical Device Week archives from April 2005

1st patient enrolled in ACT I trial of Abbott carotid stent.
April 4, 2005... 1st patient enrolled in ACT I trial of Abbott carotid stent By HOLLAND JOHNSON Medical Device Daily Associate Managing Editor The first patient in the U.S. to be enrolled in Abbott Laboratories' (Abbott Park, Illinois) landmark...

Life after DES: Looking for the next blockbuster product.(drug eluting stent)
April 4, 2005... Life after DES: Looking for the next blockbuster product By CHRISTOPHER DELPORTE Medical Device Daily Washington Editor WASHINGTON - As they enter the market, most new medical devices owe their possible success to a convergence of...

Report from Europe.
April 4, 2005... Report from Europe UK cuts more arm's length fat as bureaucracy shrinks A Medical Device Daily Staff Report The UK has marked another milestone in its drive to trim the National Health Service's (NHS) bureaucracy. Health...

CIO: Putting EMR in place a battle fought 'in trenches'.(electronic medical records)(Interview)
April 4, 2005... Third of three stories CIO: Putting EMR in place a battle fought 'in trenches' By DON LONG Medical Device Daily Managing Editor ATLANTA - Yes, electronic medical records (EMRs) are out there. Somewhat rarely in the individual...

BioCurex licenses biomarker to Abbott in 1st major deal.
April 4, 2005... BioCurex licenses biomarker to Abbott in 1st major deal By JENNIFER BOGGS Medical Device Daily Staff Writer Despite its early struggles in a sluggish market, BioCurex (Richmond, British Columbia) is finally hitting its stride. ...

Financings roundup.
April 4, 2005... Financings roundup Hemosol reports new accords; Recom raises private $5 million A Medical Device Daily Staff Report Hemosol (Mississauga, Ontario), a company focused on the development of biologics, particularly blood-related...

Deals roundup.
April 4, 2005... Deals roundup Elekta, Impac Medical close in on completion of merger A Medical Device Daily Staff Report Elekta (Stockholm, Sweden) and Impac Medical Systems (Mountain View, California) reported the expiration of the waiting period...

Court report.
April 4, 2005... Court report Zimmer receives subpoena from U.S. Attorney's office A Medical Device Daily Staff Report Zimmer Holdings (Warsaw, Indiana) said that it has received a subpoena from the U.S. Department of Justice through the U.S....

Small things can mean a lot in new-tech adoption.(Brief Article)
April 4, 2005... Small things can mean a lot in new-tech adoption T-shirts can mean a lot. They might be among the "small things" that trigger emotional involvement and help a big project work, according to Dedra Cantrell, RN. In her presentation at...

People in Places.
April 4, 2005... People in Places * John Sheridan Jr. will join the management team of Cooper Health System (Camden, New Jersey) on July 1 as senior executive vice president. Sheridan has been a partner at Riker Danzig Scherer Hyland & Perretti since 1985,...

NovaMed reports death of founder/CEO Stephen Winjum.(Brief Article)
April 4, 2005... NovaMed reports death of founder/CEO Stephen Winjum NovaMed (Chicago) reported the death March 30 of Stephen Winjum, the company's founder, chairman, president and CEO, from complications of a heart attack he suffered two days earlier. ...

Product Briefs.
April 4, 2005... Product Briefs * Cynosure (Chelmsford, Massachusetts), a manufacturer of cosmetic and medical lasers, launched its newest pulsed light system, the PhotoSilk Plus, at the American Society for Laser Medicine and Surgery conference, which...

Sorenson using molecular information to trace families.(Sorenson Molecular Genealogy Foundation )
April 5, 2005... Sorenson using molecular information to trace families By KAREN YOUNG Medical Device Daily Staff Writer Just punch into the computer the numerical values of certain genetic biomarkers, and - just like that! - access your own family...

Siemens presents study results, new products at AAA meeting.
April 5, 2005... Siemens presents study results, new products at AAA meeting By KIM URQUHART Medical Device Daily Staff Writer Siemens Hearing Instruments (Piscataway, New Jersey) hoped audiologists were all ears at last week's American Academy of...

Report from Europe.
April 5, 2005... Report from Europe University of Southampton trial to use Inovio's MedPulser tech A Medical Device Daily Staff Report Inovio Biomedical (formerly Genetronics Biomedical; San Diego) reported that is has launched, in collaboration...

Subintimal angioplasty for PAD found effective as alternative.(peripheral arterial disease)
April 5, 2005... Society of Interventional Radiology Subintimal angioplasty for PAD found effective as alternative A Medical Device Daily Staff Report Treating long segments of a blocked artery with subintimal angioplasty, followed by stenting, as...

Ventaira gets $13.5M in 'C' round; PPT reports share buy of $4.2M.
April 5, 2005... Ventaira gets $13.5M in 'C' round; PPT reports share buy of $4.2M A Medical Device Daily Staff Report Ventaira Pharmaceuticals (Columbus, Ohio), a company developing a device for improved delivery of drugs to the respiratory system,...

Deals roundup.
April 5, 2005... Deals roundup Clearant closes $11M merger; Spacelabs, Nellcor in alliance A Medical Device Daily Staff Report Clearant (Los Angeles), a developer of a pathogen inactivation technology, reported completing its reverse merger with...

Financings roundup.
April 5, 2005... Financings roundup DU gets first phase of $34M; MedicalCV closes on Series A A Medical Device Daily Staff Report Diagnostic Ultrasound (DU; Bothell, Washington), a company developing application-specific medical ultrasound devices...

Grants/contracts.
April 5, 2005... Grants/contracts Delphi signs with PremaCare to develop neonatal care incubator A Medical Device Daily Staff Report Delphi Medical Systems, a subsidiary of Delphi (both Troy, Michigan), signed an exclusive worldwide agreement with...

Product Briefs.
April 5, 2005... Product Briefs * AnorMED (Vancouver, British Columbia) reported filing for approval an investigational new drug application with the FDA to begin its clinical program for AMD3100 in cardiac patients. The filing is the first step in...

People in Places.
April 5, 2005... People in Places * Eran Aharonson has been appointed vice president, computational life science research and development for Compugen (Tel Aviv, Israel). Aharonson joins Compugen from Advanced Recognition Technologies, where he served for...

Summit highlights quality gaps, disparity in U.S. healthcare.(Agency for Healthcare Research and Quality )
April 6, 2005... Summit highlights quality gaps, disparity in U.S. healthcare By CHRISTOPHER DELPORTE Medical Device Daily Washington Editor WASHINGTON - According to Carolyn Clancy, MD, director of the Agency for Healthcare Research and Quality...

Webcast AAA repair procedure uses Excluder endoprosthesis.
April 6, 2005... Webcast AAA repair procedure uses Excluder endoprosthesis By CYNTHIA DRAKE Medical Device Daily Contributing Writer An Internet audience was treated to a recent live webcast of a minimally invasive surgical (MIS) repair of an...

Report from Europe.
April 6, 2005... Report from Europe Impac now Elekta subsidiary with close of $190 million deal A Medical Device Daily Staff Report Elekta (Stockholm, Sweden) reported completing its acquisition of Impac Medical Systems (Mountain View, California),...

Neil Young's aneurysm treatment highlights interventional success.
April 6, 2005... Society of Interventional Radiology Neil Young's aneurysm treatment highlights interventional success A Medical Device Daily Staff Report New medical procedures often receive their largest public recognition when used to treat...

Financings roundup.
April 6, 2005... Financings roundup SP Industries gathers in $10.5M; senior facility upsized for Salus A Medical Device Daily Staff Report SP Industries (Warminster, Pennsylvania), a manufacturer of laboratory research and process equipment,...

FDA issues final rule banning CFC propellants for albuterol.(chlorofluorocarbon)
April 6, 2005... FDA issues final rule banning CFC propellants for albuterol A Medical Device Daily Staff Report The FDA last week issued a final rule phasing out the use of albuterol metered-dose inhalers (MDIs) using chlorofluorocarbon (CFC)...

FDA asks Inamed for additional information on gel-filled implant.(Brief Article)
April 6, 2005... FDA asks Inamed for additional information on gel-filled implant A Medical Device Daily Staff Report Inamed (Santa Barbara, California) reported receiving a letter from the FDA concerning its Style 410 cohesive gel-filled breast...

Briefly Noted.
April 6, 2005... Briefly Noted Study cites outpatient surgery savings Medicare would save more than $1 billion a year if certain surgical procedures were performed in the nation's ambulatory surgery centers rather than hospital outpatient departments,...

Deals roundup.
April 6, 2005... Deals roundup Neoprobe licenses two patents supporting RIGS development A Medical Device Daily Staff Report Neoprobe (Dublin, Ohio), a developer of oncology diagnostic and treatment products and cardiovascular surgical and...

Grants/contracts.
April 6, 2005... Grants/contracts Hx Technologies granted $1.7M to expand Philadelphia network A Medical Device Daily Staff Report The National Cancer Institute of the National Institutes of Health (NIH; both Bethesda, Maryland) has awarded a $1.7...

People in Places.
April 6, 2005... People in Places * Carter BloodCare CEO Merlyn Sayers, PhD, has been elected president of America's Blood Centers (Washington), North America's largest network of non-profit, community blood centers. He will serve as president for two...

Product Briefs.
April 6, 2005... Product Briefs * Applied Biosystems Group (Foster City, California), a business of Applera, together with its joint venture partner MDS Sciex (Toronto), a division of MDS, reported the launch of two new mass spectrometers, the 3200 Q TRAP...

Cyberkinetics receives 1st FDA clearance for NeuroPort System.
April 7, 2005... Cyberkinetics receives 1st FDA clearance for NeuroPort System By HOLLAND JOHNSON Medical Device Daily Associate Managing Editor A company developing products for the emerging neurotechnology market reported that it has gotten its...

Court report.
April 7, 2005... Court report Fresenius Medical Care gets DoJ subpoena for documents A Medical Device Daily Staff Report Fresenius Medical Care (Bad Homburg, Germany), which bills itself as the world's largest provider of dialysis products and...

Report from Europe.
April 7, 2005... Report from Europe Boston Sci: 'full range' of DES sizes launched internationally A Medical Device Daily Staff Report Boston Scientific (Natick, Massachusetts) reported this week that it has received CE marking for three large...

Financings roundup.
April 7, 2005... Financings roundup ev3 makes SEC filing for IPO; SkinMedica in $15M placement A Medical Device Daily Staff Report ev3 (Plymouth, Minnesota) on Tuesday reported that it has filed a registration statement with the Securities and...

Mentor-sponsored survey says women back breast implants.
April 7, 2005... Mentor-sponsored survey says women back breast implants A Medical Device Daily Staff Report Breast implant manufacturer Mentor (Santa Barbara, California) has released results of a new national online survey of breast augmentation...

Genetronics changes name to Inovio.(Brief Article)
April 7, 2005... Genetronics changes name to Inovio Genetronics Biomedical (San Diego), which is developing oncology and other therapies using electroporation to deliver drugs and nucleic acids, said that it has changed its corporate name to Inovio...

Report from Israel.
April 7, 2005... Report from Israel Rosetta Genomics gathers in $4 million for preclinical work By RAE FISHMAN Medical Device Daily Correspondent ZICHRON YAAKOV, Israel - Rosetta Genomics reported that it has completed its third financing...

Briefly Noted.
April 7, 2005... Briefly Noted RITA files 10-K for 2004 RITA Medical Systems (Mountain View, California) reported it filed its Form 10K for the year ended Dec. 31, 2004, on March 31. The company said on March 16 that it had requested a two-week filing...

Impac, Synovate in onocology audit.(Brief Article)
April 7, 2005... Impac, Synovate in onocology audit Impac Medical Systems (Mountain View, California), a provider of information technology solutions for oncology care and part of the Elekta Group, and Synovate Healthcare, a specialist division of global...

invivodata launches new division.(Brief Article)
April 7, 2005... invivodata launches new division invivodata (Pittsburgh), focused on electronic patient reported outcomes (PRO) solutions for clinical research, has launched a new division, PRO Consulting, in response, it said, to demand from trial...

People in Places.
April 7, 2005... People in Places * Arlene Chiu, PhD, has been appointed director of scientific programs and review for the California Institute for Regenerative Medicine (CIRM; Emeryville, California). Chiu is a developmental neurobiologist who is...

Senior execs to lead AdvaMed with Bailey's departure to CTFA.(Pamela Bailey)(Cosmetic, Toiletry and Fragrance Association)(Advanced Medical Technology Association)(Brief Article)
April 7, 2005... Senior execs to lead AdvaMed with Bailey's departure to CTFA A Medical Device Daily Staff Report This week begins new, but interim, management of the Advanced Medical Technology Association (AdvaMed; Washington), with the departure of...

Grants/contracts.
April 7, 2005... Grants/contracts Healthlink in $4M accord with Christus Health for IT initiative A Medical Device Daily Staff Report Healthlink (Houston), a healthcare information systems consulting firm, reported the signing of a $4 million...

Cardiovascular roundup.
April 8, 2005... Cardiovascular roundup Arrow discontinues its LionHeart LVAS effort to focus on CoreAide By HOLLAND JOHNSON Medical Device Daily Associate Managing Editor After nearly a decade of development and millions of dollars invested,...

CMS funds back small-practice adoption of EHR technology.(electronic health records)
April 8, 2005... CMS funds back small-practice adoption of EHR technology By CHRISTOPHER DELPORTE Medical Device Daily Washington Editor WASHINGTON - There are many issues affecting the widespread adoption of electronic health records (EHRs) -...

Report from Europe.
April 8, 2005... Report from Europe U. of St. Andrews wins funding to develop 'super' microscope A Medical Device Daily Staff Report Scientists at the University of St. Andrews (St. Andrews, Scotland) reported yesterday that they have won a...

GW Medical, assuming FDA OK, set to market 1st AD blood test.
April 8, 2005... GW Medical, assuming FDA OK, set to market 1st AD blood test By KAREN YOUNG Medical Device Daily Staff Writer If all goes as planned, GW Medical Technologies (Phoenix) expects to have a blood test for Alzheimer's disease (AD) on...

Washington Roundup.
April 8, 2005... Washington Roundup Reprocessors reaffirm safety commitment at board meeting A Medical Device Daily Staff Report Perhaps one of the hardest challenges faced by medical device reprocessors is one of perception. Following its...

Deals roundup.
April 8, 2005... Deals roundup W.L. Gore purchases Tetrad; St. Jude closes Velocimed buy A Medical Device Daily Staff Report W.L. Gore & Associates (Newark, Delaware), a developer of fluoropolymer-based surgical and medical OEM products, has...

Infectech changes name to NanoLogix.(Brief Article)
April 8, 2005... Infectech changes name to NanoLogix Infectech (Sharon, Pennsylvania) - a nano-biotechnology company engaged in the research and development of technologies for the production of bacteria - and disease-testing kits, alternative sources of...

Grants/contracts.
April 8, 2005... Grants/contracts NIH $750,000 to support Phase II research by Implant Sciences A Medical Device Daily Staff Report Implant Sciences (Wakefield, Massachusetts), a manufacturer of products for medicine and national security, reported...

Cyberonics reports response to FDA warning letter 'complete'.(Brief Article)
April 8, 2005... Cyberonics reports response to FDA warning letter 'complete' A Medical Device Daily Staff Report Cyberonics (Houston) reported on Wednesday, during a conference call with the FDA's Dallas District Office, that the agency found its...

Five years for Edwards as public company.(Brief Article)
April 8, 2005... Five years for Edwards as public company Edwards Lifesciences (Irvine, California) celebrated its five-year anniversary Monday as a publicly traded company. As part of its celebration, the company announced the creation of the new...

Physiometrix' 10-K includes 'going concern'.(Brief Article)
April 8, 2005... Physiometrix' 10-K includes 'going concern' Physiometrix (North Billerica, Massachusetts) said that its 2004 financial statements included in the company's Form 10-K, filed on March 31, with the Securities and Exchange Commission, contained...

People in Places.
April 8, 2005... People in Places * Anne Curtis, MD, will be named president of the Heart Rhythm Society (Washington), which bills itself as the leading professional society for cardiac arrhythmia professionals and the primary information resource on heart...

Product Briefs.
April 8, 2005... Product Briefs * Biopure (Cambridge, Massachusetts) reported completing enrollment in the Phase II human clinical trial in Europe evaluating the safety and feasibility of its investigational oxygen therapeutic Hemopure [hemoglobin glutamer...

Confluent's DuraSeal approved by FDA for sutured dural repair.
April 11, 2005... Confluent's DuraSeal approved by FDA for sutured dural repair By HOLLAND JOHNSON Medical Device Daily Associate Managing Editor The FDA reported that it approved a new product designed to protect against leakage of cerebrospinal...

Diabetic pain, lack of circulation targeted by Anodyne Therapy.
April 11, 2005... Diabetic pain, lack of circulation targeted by Anodyne Therapy By KIM URQUHART Medical Device Daily Staff Writer Anodyne Therapy (Tampa, Florida) has both an unusual name - "anodyne" meaning "relieving or lessening pain,"...

International report.
April 11, 2005... International report Second indication of BrachySil for cancer initiated by pSivida A Medical Device Daily Staff Report Nanotechnology company pSivida (Perth, Australia) reported that it has initiated a full development of its...

Report from Israel.
April 11, 2005... Report from Israel Mirabel raises $9M for EIS breast scan screen for younger women By RAE FISHMAN Medical Device Daily Correspondent ZICHRON YAAKOV, Israel - Breast cancer screening system developer Mirabel Medical Systems...

Demonstration project to analyze expanded chiropractic coverage.
April 11, 2005... CMS roundup Demonstration project to analyze expanded chiropractic coverage A Medical Device Daily Staff Report Medicare coverage for chiropractic care currently is limited to what chiropractors are most known for: manual...

Deals roundup.
April 11, 2005... Deals roundup Bio-Rad in offer for BioSource; AMO, Visx set record date A Medical Device Daily Staff Report BioSource International (Camarillo, California) reported that it has received an unsolicited proposal from Bio-Rad...

Court report.
April 11, 2005... Court report Medtronic ICD class action filed; Pediatrix will take $6M charge A Medical Device Daily Staff Report A class action on behalf of users of several types of defibrillators made by Medtronic (Minneapolis) has been filed...

Financings roundup.
April 11, 2005... Financings roundup National Renal adds $40 million; Ambrx in stock sale of $23M A Medical Device Daily Staff Report Signaling what it said is a vote of confidence in its "vision" for opening dialysis clinics in underserved markets,...

'Going concern' reports issued by auditors of Cardima, NeoRx.
April 11, 2005... 'Going concern' reports issued by auditors of Cardima, NeoRx A Medical Device Daily Staff Report Two companies - Cardima (Fremont, California) and NeoRx (Seattle) - were among those that reported "going concerns" last week. ...

Briefly Noted.
April 11, 2005... Briefly Noted AHRQ to meet April 15 The National Advisory Council for Healthcare Research and Quality (AHRQ; Washiington) will meet on April 15, from 9 a.m. to noon, at the Hubert H. Humphrey Building in Washington. The meeting,...

Bayer BP launches California HQ, reports executive team.
April 11, 2005... Bayer BP launches California HQ, reports executive team A Medical Device Daily Staff Report Bayer Biological Products (Bayer BP) last week celebrated the opening of its new global headquarters for its division in Berkeley, California,...

People in Places.
April 11, 2005... People in Places * Shawn Cain has been named vice president operations for Arbios Systems (Los Angeles), a company developing devices for the treatment of liver failure, effective April 25. Cain joins Arbios from Becton Dickinson &...

Product Briefs.
April 11, 2005... Product Briefs * Bausch & Lomb (B&L; Rochester, New York) said that the FDA approved its PureVision Toric (balafilcon A) visibility-tinted contact lens for vision correction in people with astigmatism. Made from the company's silicone...

Emotional testimony presented on lifting breast implant ban.
April 12, 2005... Emotional testimony presented on lifting breast implant ban By CHRISTOPHER DELPORTE Medical Device Daily Washington Editor GAITHERSBURG, Maryland - For the second time in less than two years, the FDA is debating silicone-gel breast...

Abbott submits a PMA for its latest vascular closure system.(premarket approval)
April 12, 2005... Abbott submits a PMA for its latest vascular closure system By HOLLAND JOHNSON Medical Device Daily Associate Managing Editor If all goes according to plan, the Abbott Vascular Devices (Redwood City, California) division of Abbott...

Report from Europe.
April 12, 2005... Report from Europe Eucomed lauds EC's proposal on 7th Framework for Research A Medical Device Daily Staff Report The European medical technology industry association, Eucomed (Brussels, Belgium), said that it "welcomes" a European...

Financings roundup.
April 12, 2005... Financings roundup CryoCor files plans for IPO; $14.35M buoys Staar Surgical A Medical Device Daily Staff Report CryoCor (San Diego), a medical device manufacturer developing technologies to treat cardiac arrhythmias, last week...

Deals roundup.
April 12, 2005... Deals roundup Refac eyes two potential buys; Siemens-CTI deal advances A Medical Device Daily Staff Report Refac (Fort Lee, New Jersey) reported that it has expressed interest in exploring an acquisition of OptiCare Health Systems...

Court report.
April 12, 2005... Court report Cytyc reports dismissal of shareholder action against it A Medical Device Daily Staff Report Cytyc (Marlborough, Massachusetts), a developer of women's health technologies, reported that Judge Nathaniel Gorton has...

Grants/contracts.
April 12, 2005... Grants/contracts Respironics licenses Axeda's system for remote monitoring A Medical Device Daily Staff Report Axeda Systems (Mansfield, Massachusetts), a provider of device relationship management (DRM) software and services,...

Air Methods expands hospital operations.(Brief Article)
April 12, 2005... Air Methods expands hospital operations Air Methods (Denver) said that it has expanded its hospital-based operations within Arizona, Colorado, Minnesota, North Carolina, Oklahoma, Tennessee, Utah, Virginia and West Virginia. Each of these...

SeraCare retains The Trout Group.(Brief Article)
April 12, 2005... SeraCare retains The Trout Group SeraCare Life Sciences (Oceanside, California) said that it has engaged The Trout Group, a life sciences investor relations and advisory firm. The Trout Group will work with SeraCare to promote the...

People in Places.
April 12, 2005... People in Places * Gene Fleming has been named president and CEO of Cogent Healthcare (Irvine, California), a provider of services that improve the well-being of hospitalized patients. Most recently, Fleming was president and CEO of...

Product Briefs.
April 12, 2005... Product Briefs * MedMined (Birmingham, Alabama), a medical information technology company, reported the introduction of the Nosocomial Infection Marker (NIM), a new feature of its Data Mining Surveillance technology that for the first time...