Medical Device Week articles from July 2005

Medical Device Week archives from July 2005

Holiday notice.
July 1, 2005... Holiday notice Medical Device Daily's offices will be closed Monday, July 4, and Tuesday, July 5, in observance of the Independence Day holiday in the U.S. No issues will be published on those days. The next issue of MDD will be published...

NxStage's System One takes dialysis to home - and road.
July 1, 2005... NxStage's System One takes dialysis to home - and road By DON LONG Medical Device Daily Managing Editor Another company has entered the home hemodialysis sector and, taking that use even further, is putting its technology on wheels...

Acorn's Lunsford 'surprised' by panel vote, still optimistic.(Acorn Cardiovascular)
July 1, 2005... Acorn's Lunsford 'surprised' by panel vote, still optimistic By CHRISTOPHER DELPORTE Medical Device Daily Washington Editor WASHINGTON - Last week, a negative FDA panel vote left officials at Acorn Cardiovascular (St. Paul,...

International report.
July 1, 2005... International report China gives regulatory okay to Cardiac Science AEDs A Medical Device Daily Staff Report Cardiac Science (Irvine, California) said it has received regulatory approval from China's State Food and Drug...

Webcast focuses on minimally invasive parathyroid surgery.
July 1, 2005... Webcast focuses on minimally invasive parathyroid surgery By CYNTHIA DRAKE, RN Medical Device Daily Contributing Writer Endocrine surgeon James Norman, MD, performed a minimally invasive radioguided parathyroid (MIRP) surgery...

Financings roundup.
July 1, 2005... Financings roundup Tm Bioscience gets $3.8 million; Spire earns $3M license payment A Medical Device Daily Staff Report Tm Bioscience (Toronto), a developer of commercial genetic tests, reported that it has received a total of $3.8...

Deals roundup.
July 1, 2005... Deals roundup Viasys sells non-core assets; Biofield, BPG agree to merge A Medical Device Daily Staff Report Viasys Healthcare (Conshohocken, Pennsylvania) reported that it has completed the sale of the obstetrics and...

Grants/contracts.
July 1, 2005... Grants/contracts Smiths Medical awarded new contract from Premier GPO A Medical Device Daily Staff Report Smiths Medical MD (St. Paul, Minnesota) has been awarded a three-year contract by Premier Purchasing Partners (San Diego) to...

Aksys looking to next 12-18 months 'to shape our destiny'.(maker of Personal Hemodialysis System)
July 1, 2005... Aksys looking to next 12-18 months 'to shape our destiny' Aksys (Lincolnshire, Illinois) in 2002 reported winning FDA clearance for the first home dialysis device, the Personal Hemodialysis (PHD) System - thus posting a "major breakthrough"...

Briefly Noted.
July 1, 2005... Briefly Noted BioSource completes financial restatement BioSource International (Camarillo, California) reported it has completed the restatement of its financial results for the three years ended Dec. 31, 2004, and has filed with the...

People in Places.
July 1, 2005... People in Places * BriteSmile (Walnut Creek, California), a provider of advanced teeth whitening technologies and products, reported that effective immediately, Dr. Julian Feneley, company president, has assumed all of the responsibilities...

Product Briefs.
July 1, 2005... Product Briefs * NeoPharm (Lake Forest, Illinois) reported that the independent data monitoring committee responsible for overseeing its Phase III PRECISE trial has reviewed the data for the trial's first futility analysis and has...

Task force recommends HIV test for all pregnant women.
July 6, 2005... Task force recommends HIV test for all pregnant women By KAREN YOUNG Medical Device Daily Staff Writer A task force of the Agency for Healthcare Research and Quality (AHRQ; Rockville, Maryland) has issued a new recommendation...

Court report.
July 6, 2005... Court report UTMD to get day in court; deliberations in J&J-BSX A Medical Device Daily Staff Report The setting of a trial date in a long-running dispute between the FDA and a medical technology company, as well as the start of...

Report from Europe.
July 6, 2005... Report from Europe NMT gets go-ahead for UK trial of BioSTAR technology A Medical Device Daily Staff Report NMT Medical (Boston) said it has received approvals to initiate a multi-center clinical study in the United Kingdom to...

New study highlights the link between X-rays and cancer.
July 6, 2005... New study highlights the link between X-rays and cancer By CHRISTOPHER DELPORTE Medical Device Daily Washington Editor WASHINGTON - Low doses of radiation such as X-rays can lead to cancer, according to a new report from the...

Three Guidant ICD recalls are given Class I status by FDA.(implantable cardioverter defibrillators)
July 6, 2005... Three Guidant ICD recalls are given Class I status by FDA By HOLLAND JOHNSON Medical Device Daily Associate Managing Editor In the wake of its recent physician communications, Guidant (Indianapolis) reported late last week that the...

Financings roundup.
July 6, 2005... Financings roundup BSX acquires Biophan stake; Ardent Health prices offer A Medical Device Daily Staff Report Biophan Technologies (West Henrietta, New York), a developer of next-generation biomedical technology, reported reaching...

Briefly Noted.
July 6, 2005... Briefly Noted Fish oil not a help with arrhythmia People who have diets high in fish oil have been shown to be at lower risk of dying from heart attacks. But a new study has found that fish oil supplements may pose a risk to some...

Grants/contracts.
July 6, 2005... Grants/contracts University of Michigan gets $10M from NIH for memory A Medical Device Daily Staff Report Alzheimer's disease research at the University of Michigan (U-M; Ann Arbor, Michigan) is getting a $10 million boost: a major...

PaperFree Medical implements cost control.(Brief Article)
July 6, 2005... PaperFree Medical implements cost control PaperFree Medical (Kokomo, Indiana) reported that it has implemented a cost-control plan to reduce costs to become break-even on a cash-flow basis. These measures have been taken by new management...

People in Places.
July 6, 2005... People in Places * Todd Fanning has been named president of BioMedical Enterprises (BME; San Antonio), Inc. (BME), a bone fixation and musculoskeletal research service company. Fanning brings 20 years of healthcare and medical device...

Product Briefs.
July 6, 2005... Product Briefs * etrials Worldwide (Morrisville, North Carolina), which offers fully integrated, easy-to-use eClinical software for the clinical trial process, reported that it has deployed a hybrid clinical study that includes both...

Philips in $280M Stentor buy; Tyco adding Vivant for $66M.
July 7, 2005... Philips in $280M Stentor buy; Tyco adding Vivant for $66M A Medical Device Daily Staff Report Royal Philips Electronics (Best, the Netherlands) yesterday reported that it would acquire Stentor (Brisbane, California), a provider of...

Veteran medical device exec to leave Closure for start-up.(Dan Pelak goes to Interventional Rhythm Management)
July 7, 2005... Veteran medical device exec to leave Closure for start-up By HOLLAND JOHNSON Medical Device Daily Associate Managing Editor After nearly 30 years in the medical device industry with increasing levels of responsibility, it would...

Report from Europe.
July 7, 2005... Report from Europe Improvements in ambulance service coming to England A Medical Device Daily Staff Report "Sweeping improvements" are in the works for England's ambulance service. The changes unveiled by UK Health Minister Lord...

Diagnostics & Imaging book eyes growth opportunities.(Diagnostics & Imaging: Emerging Markets for the 21st Century)(Brief Article)(Book Review)
July 7, 2005... Diagnostics & Imaging book eyes growth opportunities Production on the BBI group's latest sourcebook, Advances in Diagnostics & Imaging: Emerging Markets for the 21st Century, has been completed and the 310-page volume is now available. ...

Court report.
July 7, 2005... Court report Jury rules that Cordis stents infringe 2 Boston Sci patents A Medical Device Daily Staff Report A Delaware jury ruled late on Friday that Cordis (Miami Lakes, Florida), with its Cypher, Bx Velocity, Bx Sonic and...

Deals roundup.
July 7, 2005... Deals roundup Transneuronix buy completed; West adds Medimop for $40M A Medical Device Daily Staff Report Medtronic (Minneapolis) reported completing its acquisition of Transneuronix (Mt. Arlington, New Jersey), a device company...

Grants/contracts.
July 7, 2005... Grants/contracts GE Healthcare, IHC report 1st joint project in patient safety A Medical Device Daily Staff Report GE Healthcare (Waukesha, Wisconsin) and Intermountain Health Care (IHC; Salt Lake City), an integrated healthcare...

Briefly Noted.
July 7, 2005... Briefly Noted A.C.T. now advanced Cell Technology A.C.T. Holdings (Worcester, Massachusetts) reported that it has changed its name to Advanced Cell Technology, and the company's trading symbol has been changed from ACTH to ACTC. The...

People in Places.
July 7, 2005... People in Places * Bernard "Dino" Alfano, vice president of global sales and service for IRIS International (Chatsworth, California), has been promoted to president of the company's newly created Diagnostics Business Unit. The company also...

Product Briefs.
July 7, 2005... Product Briefs * Alliance Medical (Phoenix), a reprocessor of single-use medical devices (SUDs), reported FDA clearance of its Reprocessed Ultrasonic Scalpels 510(k). The instruments are used for soft tissue incisions when bleeding control...

NuVasive files for an IDE on total disc replacement device.(investigational device exemption)
July 7, 2005... NuVasive files for an IDE on total disc replacement device A Medical Device Daily Staff Report NuVasive (San Diego), focused on developing products for minimally disruptive surgical treatments for the spine, reported that it filed for...

Sen. Kennedy introduces still another HIT legislative effort.(Edward Kennedy )(healthcare information technology )
July 8, 2005... Sen. Kennedy introduces still another HIT legislative effort By CHRISTOPHER DELPORTE Medical Device Daily Washington Editor WASHINGTON – Last week, prior to Congress' 4th of July recess, Sen. Edward Kennedy (D-Massachusetts)...

Competition win jump-starts early stage balance aid firm.
July 8, 2005... Competition win jump-starts early stage balance aid firm By KIM URQUHART Medical Device Daily Staff Writer Balance is something that comes naturally to most of us, as automatic as breathing. But for some – the elderly and...

Report from Europe.
July 8, 2005... Report from Europe Researchers report antibody might change diabetes course A Medical Device Daily Staff Report The Juvenile Diabetes Research Foundation (JDRF; New York), the leading global charity funding research into Type 1...

Report from Israel.
July 8, 2005... Report from Israel Three gatherings emphasize growing interest in med-tech By RAE FISHMAN Medical Device Daily Correspondent ZICHRON YAAKOV, Israel – A whirlwind of activity, including three major conferences, has...

Court report.
July 8, 2005... Court report Texas man lines up in another of mounting suits vs. Guidant A Medical Device Daily Staff Report A Corpus Christi, Texas, man has filed a lawsuit against Guidant (Indianapolis), claiming that the company "concealed"...

Deals roundup.
July 8, 2005... Deals roundup Millipore acquires NovAseptic; AMS completes buy of Ovion A Medical Device Daily Staff Report Millipore (Billerica, Massachusetts) reported entering into an agreement to acquire NovAseptic (Gothenburg, Sweden). In a...

Conceptus to pursue other legal claims after turn-down.
July 8, 2005... Conceptus to pursue other legal claims after turn-down A Medical Device Daily Staff Report Conceptus (San Carlos, California) said that it has failed to block the purchase of Ovion (Menlo Park, California) by American Medical Systems...

Financings roundup.
July 8, 2005... Financings roundup Endologix adding $15.5 million as Powerlink marketing boost A Medical Device Daily Staff Report Endologix (Irvine, California), manufacturer of the Powerlink System for the minimally invasive treatment of...

Briefly Noted.
July 8, 2005... Briefly Noted Texas law backs care of diabetic students The American Diabetes Association (ADA; Alexandria, Virginia) applauded the signing of the "Diabetes School Care Act," legislation in the state of Texas that is designed to help...

Medinol seeking $2B to $4B in damages from Boston Sci.(Brief Article)
July 8, 2005... Medinol seeking $2B to $4B in damages from Boston Sci Medinol (Tel Aviv, Israel) is suing Boston Scientific (Natick, Massachusetts) for $2 billion to $4 billion, Rory Millson, the lead attorney representing the Israeli stent manufacturer,...

People in Places.
July 8, 2005... People in Places • Jim Bullock has been named president and CEO of Atritech (Minneapolis). Bullock, previously an entrepreneur-in-residence for Split Rock Partners, also has recently served as president and CEO of Endocardial...

Product Briefs.
July 8, 2005... Product Briefs • Instrumentation Laboratory (Lexington, Massachusetts), a manufacturer of in vitro diagnostic instruments, related reagents and controls, reported that it has received FDA 510(k) clearance for its HemosIL D-Dimer HS...

Second Sight hopes to give blind 2nd chance at seeing.
July 11, 2005... Second Sight hopes to give blind 2nd chance at seeing By KAREN YOUNG Medical Device Daily Staff Writer Second Sight (Sylmar, California) is working on the second generation of an implantable device - an artificial retina - that it...

Washington roundup.
July 11, 2005... Washington roundup Women delaying care as costs increase, Kaiser study reports By CHRISTOPHER DELPORTE Medical Device Daily Washington Editor WASHINGTON - A new survey looking at access to health by women finds that a...

International report.
July 11, 2005... International report Nidek receives CE mark for 'milestone' laser algorithm A Medical Device Daily Staff Report Nidek (Gamagori, Japan) said it has received CE mark approval for its Optical Path Difference Customized Aspheric...

Deals roundup.
July 11, 2005... Deals roundup CAMP buys Seattle Systems to grow N. American orthotics A Medical Device Daily Staff Report CAMP Healthcare (Jackson, Michigan), a manufacturer of surgical supports and orthotic devices, on Friday reported that it had...

Arbios nears start of safety trial for its SEPET device.(selective plasma filtration therapy)
July 11, 2005... Arbios nears start of safety trial for its SEPET device A Medical Device Daily Staff Report Providing a corporate update during the first annual shareholders meeting of Arbios Systems (Los Angeles) last Thursday, CEO Amy Factor said...

Briefly Noted.
July 11, 2005... Briefly Noted Catalyst engages investor awareness firm CardioTech International (Wilmington, Massachusetts) reported the engagement of Catalyst Financial Resources (Portland, Oregon), an investor awareness firm, to advance the...

Financings roundup.
July 11, 2005... Financings roundup Medical Properties puts $10.50 price on 12 million-share IPO A Medical Device Daily Staff Report Medical Properties Trust (Birmingham, Alabama) reported the pricing of the initial public offering of 12,066,823...

Grants/contracts.
July 11, 2005... Grants/contracts Diagnostic Products, Thermo in clinical chemistry accord A Medical Device Daily Staff Report Diagnostic Products (Los Angeles) and Thermo Electron (Waltham, Massachusetts) reported that they have entered into an...

Court report.
July 11, 2005... Court report QuadraMed to pay $3.6M, $1.4M in notes to ex-CEO A Medical Device Daily Staff Report QuadraMed (Reston, Virginia) reported that it has settled its lawsuit with Jim Durham, former CEO of the company, making an immediate...

Gerberding names directors for four new centers at CDC.(appointments)(National Center for Health Marketing)(National Center for Environmental Health)(National Center for Injury Prevention and Control)
July 11, 2005... Gerberding names directors for four new centers at CDC A Medical Device Daily Staff Report Dr. Julie Gerberding, director of the Centers for Disease Control and Prevention (CDC; Atlanta), has named directors to head four of the...

People in Places.
July 11, 2005... People in Places * Tom McLaughlin has been promoted to the position of vice president-North America imaging sales, for E-Z-EM (Lake Success, New York). McLaughlin has served the company in a series of positions since 1989, beginning as a...

Product Briefs.
July 11, 2005... Product Briefs * BioElectronicsis (Frederick, Maryland), a developer of drug-free, anti-inflammatory patches, said that it is entering into an agreement with DataMedix (Newtown Square, Pennsylvania), a full service clinical research...

Leavitt picks heads of panel tasked with paring Medicaid.(Secretary of Health and Human Services Michael Leavitt)
July 12, 2005... Leavitt picks heads of panel tasked with paring Medicaid By CHRISTOPHER DELPORTE Medical Device Daily Washington Editor WASHINGTON - Two former governors have been named to head a new Medicare reform panel, adding a little more...

CoreValve adds 'B' $24 million; Hepalife raising $15 million.
July 12, 2005... CoreValve adds 'B' $24 million; Hepalife raising $15 million A Medical Device Daily Staff Report CoreValve (Paris) reported that it has closed on a Series B round of financing of $24 million led by Apax Partners (Paris). HealthCap also...

Report from Europe.
July 12, 2005... Report from Europe GE Healthcare, Roche combine on Alzheimer's care project A Medical Device Daily Staff Report Roche (Basel, Switzerland) and GE Healthcare (Chalfont St. Giles, UK) have joined in a drug-and-imaging agent...

Guidant reports progress is made in 2 key clinical trials.(Guidant Corp.)
July 12, 2005... Guidant reports progress is made in 2 key clinical trials By HOLLAND JOHNSON Medical Device Daily Associate Managing Editor In the wake of recent extensive recalls involving its implantable cardioverter defibrillator (ICD) devices,...

FDA letter cites Staar's failure to correct 'numerous' violations.(Staar Surgical)
July 12, 2005... FDA letter cites Staar's failure to correct 'numerous' violations A Medical Device Daily Staff Report Clouds of concern continue to cast a large shadow over the future prospects of ophthalmic manufacturer Staar Surgical (Monrovia,...

Grants/contracts.
July 12, 2005... Grants/contracts Inverness' Wampole Labs in pact with Roche for IMA test A Medical Device Daily Staff Report Inverness Medical Innovations (Waltham, Massachusetts) said that its Wampole Laboratories (Princeton, New Jersey)...

Court report.
July 12, 2005... Court report Bankruptcy process continues for cancer info firm Impath A Medical Device Daily Staff Report Impath (New York) reported that the date of the third amended joint plan of liquidation under Chapter 11 of the U.S....

Financings roundup.
July 12, 2005... Financings roundup Nydic Open MRI gets credit line and loan totaling $18.7M A Medical Device Daily Staff Report Nydic Open MRI of America (Montvale, New Jersey), a provider of MRI services, has received a $5 million revolving line...

Deals roundup.
July 12, 2005... Deals roundup VNU plans acquisition of IMS Health in $6.9B deal A Medical Device Daily Staff Report IMS Health (Fairfield, Connecticut), a provider of healthcare data, primarily for the pharmaceutical industry, is to be acquired by...

NMT reports completion of enrollment in MIST study.(NMT Medical's Migraine Intervention with STARFlex Technology study)
July 12, 2005... NMT reports completion of enrollment in MIST study A Medical Device Daily Staff Report NMT Medical (Boston) reported completing enrollment in its Migraine Intervention with STARFlex Technology (MIST) clinical study, which enrolled 147...

Product Briefs.
July 12, 2005... Product Briefs * Agilent Technologies (Palo Alto, California) has introduced what it calls "the industry's most up-to-date microarray" to provide genome-wide coverage of the zebrafish (Danio rerio), and the first commercial whole mouse...

SurModics' implant tech trial marks a break from tradition.
July 13, 2005... SurModics' implant tech trial marks a break from tradition By HOLLAND JOHNSON Medical Device Daily Associate Managing Editor Taking a new direction from its traditional business model is surface modification and drug delivery...

Adlyfe developing tests for 'mad cow,' blood screening.
July 13, 2005... Adlyfe developing tests for 'mad cow,' blood screening By KAREN YOUNG Medical Device Daily Staff Writer While controversy continues to surround how U.S. authorities are responding to a Texas cow found to have "mad cow" disease in...

Report from Europe.
July 13, 2005... Report from Europe Biosensors subsidiary gets CE mark for its Axxion DES A Medical Device Daily Staff Report Biosensors International (Singapore) said that its European subsidiary, Occam International (Eindhoven, the Netherlands),...

Financings roundup.
July 13, 2005... Financings roundup CryoCor sets 3 million-share IPO to raise up to $39 million A Medical Device Daily Staff Report Cryoablation specialist CryoCor (San Diego) has provided details on its previously reported offering, saying it will...

Money and experience draw international companies to U.S.
July 13, 2005... Making the move Money and experience draw international companies to U.S. By KAREN PIHL-CAREY Medical Device Daily Staff Writer In order to gain access to U.S. stock exchanges, blue-chip investors or university research - or...

Deals roundup.
July 13, 2005... Deals roundup TLC Vision in $24M Kremer deal; Ingen buys 2 patents A Medical Device Daily Staff Report Eye care services company TLC Vision (St. Louis) said it has acquired a majority interest in the assets of Kremer Laser Eye...

Grants/contracts.
July 13, 2005... Grants/contracts NCRR to provide $18M for 11 high-end instrumentation grants A Medical Device Daily Staff Report The National Center for Research Resources (NCRR), a component of the National Institutes of Health (NIH; both...

NO treatments for infants questioned in NICHD study.
July 13, 2005... NO treatments for infants questioned in NICHD study A Medical Device Daily Staff Report A new study from the National Institutes of Health (NIH; Bethesda, Maryland) indicates that inhaled nitric oxide (NO) therapy, used to treat lung...

Briefly Noted.
July 13, 2005... Briefly Noted Hemosol has 'going concern' qualification Hemosol (Toronto) said that pursuant to Nasdaq Marketplace Rule 4350(b)(1)(B), which requires an issuer that receives an audit opinion that contains a going concern qualification...

Court report.
July 13, 2005... Court report ACell, execs found infringing Purdue Research bio patent A Medical Device Daily Staff Report A jury in U.S. District Court for the Northern District of Indiana has found that a biomaterial manufactured by ACell...

People in Places.
July 13, 2005... People in Places * Abiomed (Danvers, Massachusetts) has named Jim Dillon vice president, Eastern U.S. sales, and Geoffrey Heldoorn vice president, Western U.S. sales. Both previously were with VNUS Medical Technologies, where Dillon was...

Product Briefs.
July 13, 2005... Product Briefs * FzioMed (San Luis Obispo, California) reported the presentation of preclinical studies demonstrating Oxiplex Gel as an injectable drug delivery system for a novel, synthetic peptide bone growth factor. The poster...

Preparedness committee wants bolstered action from BioShield.(Project BioShield)
July 14, 2005... Larger device role sought Preparedness committee wants bolstered action from BioShield By CHRISTOPHER DELPORTE Medical Device Daily Washington Editor WASHINGTON - To borrow a line from Elvis Presley, industry seems to be...

Jarvik Heart gets FDA okay for pivotal trial of FlowMaker VAD.
July 14, 2005... Jarvik Heart gets FDA okay for pivotal trial of FlowMaker VAD By HOLLAND JOHNSON Medical Device Daily Associate Managing Editor Another company took a step towards a U.S. approval for a ventricular assist device (VAD) yesterday...

International report.
July 14, 2005... International report Expansion in Latin America seen for MedMira rapid tests A Medical Device Daily Staff Report MedMira (Halifax, Nova Scotia), a provider of rapid flow-through diagnostic tests, said it has expanded its market...