Medical Device Week articles from June 2005

Medical Device Week archives from June 2005

Financings roundup.
June 1, 2005... Financings roundup One-third or more of Frazier's $475M fund to target devices By DON LONG Medical Device Daily Managing Editor California is seen by Frazier Healthcare Ventures (Seattle/Palo Alto, California) as "first and...

Zarlink unveils wireless chip for implanted device/base link.(Zarlink Semiconductor)
June 1, 2005... Zarlink unveils wireless chip for implanted device/base link By DON LONG Medical Device Daily Managing Editor Zarlink Semiconductor (Toronto/San Diego) this week introduced what it called the world's only transceiver chip designed...

Report from Europe.
June 1, 2005... Report from Europe Live-case transmission marks start of Terumo's DES trial A Medical Device Daily Staff Report Terumo Europe Interventional Systems (Leuven, Belgium), an affiliate of Terumo (Tokyo), reported at last week's EuroPCR...

Deals roundup.
June 1, 2005... Deals roundup Inverness adds Abbott tests; AMO-VISX merger completed By CHRISTOPHER DELPORTE Medical Device Daily Washington Editor Inverness Medical Innovations (Waltham, Massachusetts) said it would purchase the...

New study refutes Stamey's claim that PSA era is over.
June 1, 2005... American Urological Association New study refutes Stamey's claim that PSA era is over A Medical Device Daily Staff Report Physician scientists at Columbia University Medical Center and New York-Presbyterian Hospital (both New York)...

Briefly Noted.
June 1, 2005... Briefly Noted Physiometrix acts to avoid Nasdaq delisting Physiometrix (North Billerica, Massachusetts) said that the company received a letter from Nasdaq on April 5, which cited the company's non-compliance with the requirement that...

Grants/contracts.
June 1, 2005... Grants/contracts Novell and HHS in pact for firm's Linux product line A Medical Device Daily Staff Report Novell (Waltham, Massachusetts) and the Department of Health and Human Services (HHS; Washington) signed an agreement for...

People in Places.
June 1, 2005... People in Places * Guardian Technologies International (Herndon, Virginia), a developer of intelligent imaging informatics solutions for homeland security and radiology healthcare, has expanded its sales force by adding four additional...

Product Briefs.
June 1, 2005... Product Briefs * ACMI (Southborough, Massachusetts), which manufactures diagnostic and therapeutic endoscopic instrumentation products and systems, said that its global R&D group has developed the world's smallest digital camera and video...

Hospira to buy Physiometrix fr $23M in cash, $1M in debt.(business news)
June 2, 2005... Hospira to buy Physiometrix fr $23M in cash, $1M in debt By DON LONG Medical Device Daily Managing Editor Hospira (Lake Forest, Illinois) yesterday reported that it would expand on its offerings to the hospital sector, primarily...

Affymetrix plans to buy out ParAllele for $120M in stock.(ParAllele BioScience Inc.)
June 2, 2005... Affymetrix plans to buy out ParAllele for $120M in stock By RANDALL OSBORNE Medical Device Daily Staff Writer Affymetrix (Santa Clara, California) plans to add assay technology to its tools arsenal with the $120 million stock...

Report from Europe.
June 2, 2005... Report from Europe Cyberonics gets okay for two new VNS generator models A Medical Device Daily Staff Report Cyberonics (Houston) said that KEMA Medical, its European regulatory Notified Body, has approved the company's Model 103...

Financings roundup.
June 2, 2005... Financings roundup No Hemosense Dutch auction; shares added for $40M IPO A Medical Device Daily Staff Report HemoSense (San Jose, California), a manufacturer of meters and test strips that monitor blood coagulation, on Tuesday...

Report from Australia.
June 2, 2005... Report from Australia Norwood Abbey restructures in bid to boost U.S. presence A Medical Device Daily Staff Report Norwood Abbey (Melbourne, Australia), a drug delivery and immunology company, reported on Tuesday that it is pushing...

Court report.
June 2, 2005... Court report Jurors extend their workday in Scrushy fraud deliberations A Medical Device Daily Staff Report Despite eight days of deliberations, jurors in the fraud trial of Richard Scrushy, founder and former CEO of HealthSouth...

Deals roundup.
June 2, 2005... Deals roundup Software firms Merge eFilm, Cedara complete their merger A Medical Device Daily Staff Report Merge Technologies (Milwaukee), doing business as Merge eFilm, a healthcare software and services company, and Cedara...

Briefly Noted.
June 2, 2005... Briefly Noted Circulatory device panel to consider CorCap On June 22, the Circulatory System Device Panel of the FDA Medical Devices Advisory Committee will review a premarket approval application for the CorCap Cardiac Support Device...

Grants/contracts.
June 2, 2005... Grants/contracts Hamilton Thorne, CogniScent in pact for Electronic Nose A Medical Device Daily Staff Report Hamilton Thorne Biosciences (Beverly, Massachusetts) and CogniScent (Weston, Massachusetts) reported a collaborative...

LCD monitors gaining ground.(liquid crystal displays market)(Brief Article)
June 2, 2005... LCD monitors gaining ground Although analog-based cathode-ray tube (CRT) medical display monitors dominated the market until recently due to favorable pricing and economies of scale, liquid crystal display (LCD) monitors are fast gaining...

Product Briefs.
June 2, 2005... Product Briefs * Aethlon Medical (San Diego) reported new data related to the safe use of the Hemopurifier treatment technology in animal studies. Researchers documented that the Hemopurifier, which has been developed to treat individuals...

People in Places.
June 2, 2005... People in Places * Lucia Luce Quinn has been named executive vice president of human resources for Boston Scientific (Natick, Massachusetts). Prior to joining Boston Scientific in January, she served as senior vice president of Quest...

Angiotech unveils ADDVANCE equity unit, license to Broncus.(Angiotech Pharmaceuticals)
June 3, 2005... Angiotech unveils ADDVANCE equity unit, license to Broncus By DON LONG Medical Device Daily Managing Editor Riding high on its success in supplying paclitaxel drug technology to Boston Scientific (Natick, Massachusetts) for that...

Court report.
June 3, 2005... Court report Scooter Store takes on DoJ, CMS in reimbursement fray A Medical Device Daily Staff Report In the continuing saga concerning government reimbursement vs. no reimbursement for powered mobility equipment, The Scooter...

Report from Europe.
June 3, 2005... Report from Europe IVMD in accord to develop a diagnostic for mental illness A Medical Device Daily Staff Report In Veritas Medical Diagnostics (IVMD; Inverness, Scotland) reported signing a commercial agreement on a joint project...

NovaVision expands network of centers offering VRT tech.(Vision Restoration Therapy)
June 3, 2005... NovaVision expands network of centers offering VRT tech By CHRISTOPHER DELPORTE Medical Device Daily Washington Editor NovaVision (Boca Raton, Florida) is quickly expanding the network of medical centers offering its Vision...

New AHRQ study adds fuel to the malpractice reform fire.
June 3, 2005... New AHRQ study adds fuel to the malpractice reform fire By CHRISTOPHER DELPORTE Medical Device Daily Washington Editor WASHINGTON - Results from a new study seem to strengthen the evidence that caps on malpractice awards increase...

Deals roundup.
June 3, 2005... Deals roundup Arcadia Resources adds DME respiratory firm Health-Link A Medical Device Daily Staff Report Arcadia Resources (Southfield, Michigan), a provider of home care and staffing services, mail order pharmacy and durable...

Financings roundup.
June 3, 2005... Financings roundup superDimension $27M round will support endoscopic R&D A Medical Device Daily Staff Report superDimension (Herzliya, Israel) reported that it has completed a Series B round of financing totaling $27 million, led...

Grants/contracts.
June 3, 2005... Grants/contracts Misonix in agreement with UPMC on bone-cutting device A Medical Device Daily Staff Report Misonix (Farmingdale, New York), a developer of ultrasonic medical device technology for the treatment of cancer and other...

People in Places.
June 3, 2005... People in Places * Amisys Synertech (ASI; Rockville, Maryland) named two new vice presidents to its executive management team. Philip Spinelli joins the company as vice president, sales. For the past five years, Spinelli served as vice...

Product Briefs.
June 3, 2005... Product Briefs * Cholestech (Hayward, California) said that it has been granted a patent by the U.S. Trademark and Patent Office (no. 6,881,581) and the European Patent Office (EP 1,329,724) for a new method of measuring high-density...

AdvaMed paper: HIT requires beefed-up financial incentives.(health information technology, Advanced Medical Technology Association)
June 6, 2005... AdvaMed paper: HIT requires beefed-up financial incentives By CHRISTOPHER DELPORTE Medical Device Daily Washington Editor WASHINGTON - The Advanced Medical Technology Association (AdvaMed; Washington) has thrown its hat into the...

Cardiac biomarker use lowers risk, seen increasing in ED.(emergency department)
June 6, 2005... Cardiac biomarker use lowers risk, seen increasing in ED By KAREN YOUNG Medical Device Daily Staff Writer In the coming age of proteomics, biomarkers are going to aid tremendously - and in fact already have begun that process - in...

International report.
June 6, 2005... International report China gives Syneron the nod for sale of laser product line A Medical Device Daily Staff Report Syneron Medical (Yokneam, Israel) and its Chinese distributor, Miracle Laser (Wuhan, China), reported that China's...

Cyberonics awaits VNS okay while 'crossing i's, dotting t's'.(vagus nerve stimulation system)
June 6, 2005... Cyberonics awaits VNS okay while 'crossing i's, dotting t's' By DON LONG Medical Device Daily Managing Editor Cyberonics (Houston) on Friday issued a statement saying that it is going into a Securities and Exchange...

Deals roundup.
June 6, 2005... Deals roundup J&J closes Closure purchase; tender for Rubicon completed A Medical Device Daily Staff Report Johnson & Johnson (J&J; New Brunswick, New Jersey) on Friday reported completing its acquisition of Closure Medical...

Michigan groups plan survey of providers' IT resources.
June 6, 2005... Michigan groups plan survey of providers' IT resources A Medical Device Daily Staff Report Blue Cross Blue Shield of Michigan (BCBSM) and the Partnership for Michigan's Health (both Lansing, Michigan) are undertaking a collaborative...

Briefly Noted.
June 6, 2005... Briefly Noted ICU to maintain Salt Lake City operations ICU Medical (San Clemente, California), a manufacturer of medical connectors and custom intravenous systems, reported that it has decided to maintain certain molding and automated...

Grants/contracts.
June 6, 2005... Grants/contracts Edwards, 3F agree to re-do Percutaneous Valve accords A Medical Device Daily Staff Report Edwards Lifesciences (Irvine, California), a manufacturer of heart valve technologies, and 3F Therapeutics (Lake Forest,...

Court report.
June 6, 2005... Court report Judge urges jury to press on for verdict in trial of Scrushy A Medical Device Daily Staff Report Keep working! That was the crux of the message that U.S. District Judge Karon Bowdre delivered on Friday to the jury...

60,000 Californians to donate organs.(tissue donation)(Brief Article)
June 6, 2005... 60,000 Californians to donate organs Californians continue to step up to the plate as organ and/ or tissue donors, with more than 60,000 committing to be donors via the new Donate Life California Organ & Tissue Donor Registry (Sacramento,...

People in Places.
June 6, 2005... People in Places * Tim Henry has joined E-Z-EM (Lake Success, New York) as vice president-healthcare decontamination. Prior to joining E-Z-EM, Henry was president of SteriFleet, a consulting services firm that provided solutions and...

Product Briefs.
June 6, 2005... Product Briefs * CABG Medical (Minneapolis) said it has received approval from regulatory authorities to evaluate its Holly Graft System in clinical trials at various centers in Germany. The Holly Graft System is a paclitaxel-eluting graft...

Leavitt to form commission to speed national EHR system.(Mike Leavitt, electronic health records )
June 7, 2005... Leavitt to form commission to speed national EHR system By KAREN YOUNG Medical Device Daily Staff Writer Department of Health and Human Services (HHS; Washington) Secretary Mike Leavitt announced yesterday the creation of a...

Valve talks keep stents from stealing the EuroPCR show.(medical equipment markets)
June 7, 2005... Valve talks keep stents from stealing the EuroPCR show By HOLLAND JOHNSON Medical Device Daily Associate Managing Editor While the lion's share of the focus at this year's EuroPCR meeting in Paris last month was on the drug-eluting...

Report from Europe.
June 7, 2005... Report from Europe NHS rolls out new rules to reassure patients on records A Medical Device Daily Staff Report New rules unveiled last month by UK Health Minister Lord Warner are aimed at insuring that patients keep control over...

AMS adding Ovion for $10M, $20M in potential milestones.(American Medical Systems Holdings Inc.)
June 7, 2005... AMS adding Ovion for $10M, $20M in potential milestones A Medical Device Daily Staff Report Urological device maker American Medical Systems Holdings (AMS; Minnetonka, Minnesota) reported that it has agreed to acquire Ovion (San Mateo,...

Court report.
June 7, 2005... Court report Class actions filed vs. Possis; Thermage and Syneron settle A Medical Device Daily Staff Report Up to four class action suits have been filed on behalf of shareholders who purchased the common stock and other...

Financings roundup.
June 7, 2005... Financings roundup Curon receives $8.8 million; UHS set for share repurchase A Medical Device Daily Staff Report Curon Medical (Fremont, California) a company developing products for the treatment of gastrointestinal disorders,...

Briefly Noted.
June 7, 2005... Briefly Noted Circulatory device panel to consider CorCap On June 22, the Circulatory System Device Panel of the FDA Medical Devices Advisory Committee will review a pre-market approval application for the CorCap Cardiac Support Device...

Deals roundup.
June 7, 2005... Deals roundup NuVasive in $9 million deal to acquire RSB's SmartPlate A Medical Device Daily Staff Report NuVasive (San Diego), a company focused on developing products for minimally disruptive surgical spine treatments, reported...

Grants/contracts news.
June 7, 2005... Grants/contracts news University of Rochester adds eHealth Suite from Concord A Medical Device Daily Staff Report Concord Communications (Marlboro, Massachusetts) said that the University of Rochester Medical Center (Rochester, New...

DiaSys not in compliance with AMEX.(American Stock Exchange L.L.C.)(Brief Article)
June 7, 2005... DiaSys not in compliance with AMEX DiaSys (Waterbury, Connecticut), a global healthcare products company, said that on May 26, it received a letter from the American Stock Exchange (AMEX) advising that the company was not in compliance...

Product Briefs.
June 7, 2005... Product Briefs * Align Technology (Santa Clara, California), developer of the Invisalign method of straightening teeth without wires and brackets reported during the annual meeting of the American Association of Orthodontists in San...

People in Places.
June 7, 2005... People in Places * Eamonn Hobbs, president and CEO of AngioDynamics (Queensbury, New York), was elected to the Medical Device Manufacturers Association (MDMA; Washington) board of directors at the organization's annual meeting in...

Xoft's Axxent electronic/X-ray accents a brachy alternative.(Electronic Brachy-therapy system)
June 8, 2005... Xoft's Axxent electronic/X-ray accents a brachy alternative By DON LONG Medical Device Daily Managing Editor Brachytherapy, while receiving increasing use and proof of clinical benefit, requires the deployment of radiation via...

Study: long-term DT outcomes improved with HeartMate XVE.
June 8, 2005... Study: long-term DT outcomes improved with HeartMate XVE By HOLLAND JOHNSON Medical Device Daily Associate Managing Editor Data from a newly published study demonstrated improved outcomes of patients implanted with Thoratec's...

Report from Europe.
June 8, 2005... Report from Europe ThermoGenesis in beta launch of TPD thrombin-making unit A Medical Device Daily Staff Report ThermoGenesis (Rancho Cordova, California) is beginning the beta launch of its TPD product this month after receiving...

Financings roundup.
June 8, 2005... Financings roundup L-1 will invest in biometrics; BioCrossroads has seed fund A Medical Device Daily Staff Report Robert LaPenta has reported the formation of L-1 Investment Partners (Stamford, Connecticut), a private investment...

Court report.
June 8, 2005... Court report Covance files suit vs. PETA; Scrushy says 'no plea bargain' A Medical Device Daily Staff Report Covance (Princeton, New Jersey), a drug development services firm, reported that it has filed suit against People for the...

Roche opens world's largest PCR facility.(Roche Holding Ltd., polymerase chain reaction)(Brief Article)
June 8, 2005... Roche opens world's largest PCR facility Roche (Indianapolis) on Tuesday dedicated its new manufacturing center in Branchburg, New Jersey. The facility is the largest polymerase chain reaction (PCR) manufacturing site in the world and was...

Deals roundup.
June 8, 2005... Deals roundup EDot.com buys NanoViricides, maker of viral nanoparticles A Medical Device Daily Staff Report EDot.com (Miami) reported completing the purchase of privately held NanoViricides, a company targeting the use of...

Grants/contracts.
June 8, 2005... Grants/contracts Neurome receives Phase I SBIR grant for brain imaging A Medical Device Daily Staff Report Neurome (San Diego) said it has received a Phase I grant from the National Institutes of Health's (NIH; Bethesda, Maryland)...

Data 'bridge' used to support 510(k) application for Axxent.(Xoft tryed to gain U.S. commercialization for its Axxent Electronic Brachytherapy system)
June 8, 2005... Data 'bridge' used to support 510(k) application for Axxent An interesting - and decidedly non-intuitive - feature of FDA 510(k) regulatory clearance is highlighted by the effort of Xoft (Fremont, California) to gain U.S. commercialization...

Arrowhead says holders vote to dissolve Nanotechnica.
June 8, 2005... Arrowhead says holders vote to dissolve Nanotechnica A Medical Device Daily Staff Report Arrowhead Research (Pasadena, California) reported that a majority of the shareholders of Nanotechnica (also Pasadena) have voted to dissolve...

Product Briefs.
June 8, 2005... Product Briefs * Anodyne Therapy (Tampa, Florida) said it has re-ceived regulatory approval from Health Canada to market its Anodyne Therapy Systems. Approved Canadian labeling, based on submission of published clinical studies, includes...

Electro-Optical files for IPO; Pegasus adds B round $10M.(Electro Optical Sciences Inc., initial public offerings)
June 9, 2005... Electro-Optical files for IPO; Pegasus adds B round $10M A Medical Device Daily Staff Report Electro-Optical Sciences (EOS; Irvington, New York) reported yesterday that it has filed a statement with the Securities and Exchange...

Osiris brings in $50M to fund stem cell-based therapeutics.(Osiris Therapeutics Inc.)
June 9, 2005... Osiris brings in $50M to fund stem cell-based therapeutics By JENNIFER BOGGS Medical Device Daily Staff Writer Osiris Therapeutics (Baltimore) reported raising $50 million to fund ongoing clinical trials of its three adult stem...

Report from Israel.
June 9, 2005... Report from Israel Bio-Tech Israel 2005 meeting focuses on 'holistic' attack By RAE FISHMAN Medical Device Daily Correspondent and Staff Reports TEL AVIV, Israel - The Bio-Tech Israel 2005 meeting held at the David...

New FDA guidance for CLIA waivers expected this summer.(Clinical Laboratory Improvement Amendments of 1988)
June 9, 2005... New FDA guidance for CLIA waivers expected this summer By KAREN YOUNG Medical Device Daily Staff Writer The FDA says it is in the process of drafting new guidance as to which in vitro diagnostic tests are considered waived under...

Grants/contracts news.
June 9, 2005... Grants/contracts news Spacelabs in $6.3M contract for monitoring, telemetry A Medical Device Daily Staff Report Spacelabs Medical (Issaquah, Washington), a division of OSI Systems (Hawthorne, California), said it has received a...

FDA warns BioImagene that its web site claims are 'violations'.
June 9, 2005... FDA warns BioImagene that its web site claims are 'violations' A Medical Device Daily Staff Report The FDA has sent a letter to Mohan Uttarwar, president of BioImagene (San Jose, California), requiring the company to correct a variety...

Deals roundup.
June 9, 2005... Deals roundup Elbit eyes all Elscint shares; Essilor to buy J&J lens unit A Medical Device Daily Staff Report Elbit Medical Imaging (EMI; Tel Aviv, Israel) reported that its board of directors met last week and appointed an...

Court report.
June 9, 2005... Court report LabCorp also gets subpoena; CRF responds to PHT claim A Medical Device Daily Staff Report Laboratory Corporation of America (LabCorp; Burlington, North Carolina), a medical testing provider, said this week that it has...

Financings roundup.
June 9, 2005... Financings roundup MIV Therapeutics uses option to add 2 HAp coating licenses A Medical Device Daily Staff Report MIV Therapeutics (MIVT; Vancouver, British Columbia), a developer of next-generation biocompatible stent coatings and...

Product Briefs.
June 9, 2005... Product Briefs * Aspect Medical Systems (Newton, Massachusetts) reported that data presented at the New Clinical Drug Evaluation Unit meeting in Boca Raton, Florida, showed that the company's brain monitoring technology was able to predict...

DePuy Spine offers perspectives on future of artificial discs.(Charite artificial disc system)
June 10, 2005... DePuy Spine offers perspectives on future of artificial discs By HOLLAND JOHNSON Medical Device Daily Associate Managing Editor In the wake of Tuesday's report in the Wall Street Journal (WSJ) raising questions on the safety and...

Harvard Study provides further PVC-exposure data in infants.
June 10, 2005... Harvard Study provides further PVC-exposure data in infants By DON LONG Medical Device Daily Managing Editor A study released this week by scientists at Harvard University (Cambridge, Massachusetts) reports that babies in hospital...

Report from Europe.
June 10, 2005... Report from Europe Dutch court backs Boston Sci in case over catheter patents A Medical Device Daily Staff Report Boston Scientific (Natick, Massachusetts) yesterday reported that a Dutch court has ruled that Cordis Europa NV, a...

Bayer Diagnostics gets FDA okay for Advia hepatitis panel add-ons.
June 10, 2005... Bayer Diagnostics gets FDA okay for Advia hepatitis panel add-ons By KAREN YOUNG Medical Device Daily Staff Writer Bayer Healthcare Diagnostics Division (Tarrytown, New York) has received approval from the FDA for its automated...

HealthSouth to pay $100 million to resolve civil action by SEC.
June 10, 2005... HealthSouth to pay $100 million to resolve civil action by SEC A Medical Device Daily Staff Report HealthSouth (Birmingham, Alabama) has reported reaching an agreement with the Securities and Exchange Commission (SEC) to resolve claims...

Briefly Noted.
June 10, 2005... Briefly Noted OmniCorder becomes Advanced BioPhotonics OmniCorder Technologies (Bohemia, New York) said that the company's shareholders approved a proposal to change its name to Advanced BioPhotonics at its recent annual meeting of...

Financings roundup.
June 10, 2005... Financings roundup Correlogic gets Quest funding; Clarient, DakoCytomation team up A Medical Device Daily Staff Report Correlogic Systems (Bethesda, Maryland), a proteomics company developing pattern recognition technology for the...

Deals roundup.
June 10, 2005... Deals roundup Mercury buys Sohard for $23M; Sage picked to spin test assets A Medical Device Daily Staff Report Mercury Computer Systems (Chelmsford, Massachusetts) reported it has agreed to purchase Sohard (Ferth, Germany) for...