Medical Device Week articles from May 2006

Medical Device Week archives from May 2006

Alkermes pushing AIR system as second in inhaled insulin.
May 1, 2006... Competition aiming to dice up market Alkermes pushing AIR system as second in inhaled insulin By KAREN PIHL-CAREY Medical Device Daily Contributing Writer Think of diabetes and the device sector and you probably come up with...

WalkAide's electro-stimulation puts stroke victims back in step.
May 1, 2006... WalkAide's electro-stimulation puts stroke victims back in step By KIM URQUHART Medical Device Daily Staff Writer Today marks the start of National Stroke Awareness Month, and May marks the commercial release of the WalkAide...

Report from Israel.
May 1, 2006... Report from Israel Country's tech developments pushing regulatory envelopes By RAE FISHMAN Medical Device Daily Correspondent ZICHRON YAAKOV, Israel -- "Next-generation" is a term all-too-easily thrown about by entrepreneurs...

Now appearing: recent PMAs and 510(k)s on <I>MDD</I> web site.(premarket application )
May 1, 2006... Now appearing: recent PMAs and 510(k)s on MDD web site Have you visited www.medicaldevicedaily.com, the Medical Device Daily web site, lately? We encourage you to do so. And today you will find a new feature on that site: another...

HIV study adding African site for targeted genetics' product.
May 1, 2006... Rising interest for gene therapy? HIV study adding African site for targeted genetics' product By AARON LORENZO Medical Device Daily Staff Writer HIV researchers are enlisting a gene therapy product in an expanding study...

Shareholders vote approval for CABG liquidation plan.
May 1, 2006... Shareholders vote approval for CABG liquidation plan A Medical Device Daily Staff Report CABG Medical (Minneapolis) reported on Friday that its shareholders have voted "overwhelming" approval of the company's plan of liquidation and...

Financings roundup.
May 1, 2006... Financings roundup CPI launches $18-a-share IPO; Enologix places $50M on shelf A Medical Device Daily Staff Report CPI International (Palo Alto, California) reported the pricing of its initial public offering of 7,058,870 shares of...

Briefly Noted.
May 1, 2006... Briefly Noted Fresenius adopts Sarbanes-Oxley regs Fresenius Medical Care (Bad Homburg, Germany), a provider of dialysis products and services, said it is "one of the few" German companies to "voluntarily adopt" new U.S. regulations...

Grants/contracts.
May 1, 2006... Grants/contracts Georgia Tech center, Solvay form R&D accord for OLEDs A Medical Device Daily Staff Report The Center for Organic Photonics and Electronics (COPE) at the Georgia Institute of Technology and Solvay (Brussels,...

People in Places.
May 1, 2006... People in Places * Biovail (Toronto) said it has hired Gilbert Godin to become its senior vice-president, technical operations/drug delivery. Godin, who comes to Biovail from MDS Pharma Services where he served as president, will join the...

Product Briefs.
May 1, 2006... Product Briefs * ArthroCare (Austin, Texas) said study results published in this month's Journal of Arthroscopy and Related Surgery show the use of low-temperature bipolar radio frequency, known as Coblation technology, preserves the same...

Flixene graft, 510(k)-cleared, features use of film lamination.
May 1, 2006... Flixene graft, 510(k)-cleared, features use of film lamination By HOLLAND JOHNSON Medical Device Daily Associate Managing Editor Atrium Medical (Hudson, New Hampshire) reported that it has received FDA 510(k) clearance for a new...

Report from Canada.
May 2, 2006... Report from Canada Private/public proposals shake ground of Canadian healthcare By DAVID KOSUB Medical Device Daily Contributing Writer Those who pay attention to Canada's healthcare system -- notably doctors, patients and...

Estech's new Cobra system among multiple roll-outs.
May 2, 2006... American Association for Thoracic Surgery Estech's new Cobra system among multiple roll-outs A Medical Device Daily Staff Report At the 86th annual meeting of the American Association for Thoracic Surgery (Beverly, Massachusetts),...

International report.
May 2, 2006... International report Digital Angel tagging to be used in Brazil Hoof and Mouth effort A Medical Device Daily Staff Report Digital Angel (St. Paul, Minnesota), specializing in identification, location tracking, and condition...

Temporal lobectomy performed for treatment of epilepsy.(Medical condition overview)
May 2, 2006... Temporal lobectomy performed for treatment of epilepsy By CYNTHIA DRAKE Medical Device Daily Contributing Writer Steven Glazier, MD, assistant professor of neurosurgery at Wake Forest University Baptist Medical Center...

MediCor closes buy of breast implant firms Biosil and Nagor.
May 2, 2006... MediCor closes buy of breast implant firms Biosil and Nagor A Medical Device Daily Staff Report MediCor (Las Vegas) reported that on Friday it closed the acquisition of privately owned UK-based breast implant manufacturer Biosil and...

Financings roundup.
May 2, 2006... Financings roundup IntelliDOT adds 'C' $13 million; DOBI secures private $6 million A Medical Device Daily Staff Report IntelliDOT (San Diego), a developer of patient safety and workflow management solutions for healthcare,...

Deals roundup.
May 2, 2006... Deals roundup Laserscope adds InnovaQuartx via $7.5M, debt and milestones A Medical Device Daily Staff Report Medical laser manufacturer Laserscope (San Jose, California) reported acquiring InnovaQuartz (IQ; Phoenix). Laserscope...

Grants/contracts.
May 2, 2006... Grants/contracts Affiliated Computer signs on to $100M contract with Mississippi A Medical Device Daily Staff Report Affiliated Computer Services (ACS; Dallas), a provider of business process outsourcing and information technology...

Agreements roundup.
May 2, 2006... Agreements roundup Radiometer signs pact with MedAssets for blood gas tools A Medical Device Daily Staff Writer Radiometer America (Westlake, Ohio) has signed an agreement with MedAssets Supply Chain Systems (Atlanta) to provide...

Briefly Noted.
May 2, 2006... Briefly Noted SCAR now Society for Imaging Informatics in Medicine The Society for Computer Applications in Radiology (SCAR; Great Falls, Virginia) reported changing its name to the Society for Imaging Informatics in Medicine (SIIM),...

Steelcase launches Nurture as new health 'environment' unit.(Brief article)
May 2, 2006... Steelcase launches Nurture as new health 'environment' unit A Medical Device Daily Staff Report Office furniture specialist Steelcase (Grand Rapids, Michigan) has unveiled formation of a new subsidiary, named Nurture, focused on "the...

People in Places.
May 2, 2006... People in Places * Thomas Rosanske, PhD, has joined PPD (Wilmington, North Carolina) as executive director of product development analytical services for its cGMP laboratory. Rosanske most recently served as executive director of...

Product Briefs.
May 2, 2006... Product Briefs * NuGEN Technologies (San Carlos, California), which develops RNA amplification and labeling systems, reported release of an application note detailing results of a U.S. government lab study in which NuGEN's Ovation Biotin...

Medtronic earns CE mark for Exponent stent to treat CAD.(carotid artery disease )(Brief article)
May 2, 2006... Medtronic earns CE mark for Exponent stent to treat CAD A Medical Device Daily Staff Report Medtronic (Minneapolis) reported that it has received CE mark approval for its next-generation self-expanding carotid stent and filter system,...

CCHIT to publish EHR certification criteria.(Certification Commission for Healthcare Information Technology)(electronic health record)(Brief article)
May 3, 2006... CCHIT to publish EHR certification criteria The Certification Commission for Healthcare Information Technology (CCHIT; Chicago) said that it will publish its criteria for certification of ambulatory electronic health record (EHR) products...

Lewin Group report: Industry finds holes in user fee program.
May 3, 2006... 1st of two articles Lewin Group report: Industry finds holes in user fee program By DON LONG Medical Device Daily Managing Editor Be careful what you ask for. That might be the best advice to the medical device industry...

Financings roundup.
May 3, 2006... Financings roundup Northstar Neuroscience files for IPO that may yield over $81M A Medical Device Daily Staff Report Northstar Neuroscience (Seattle), a company focused on the development of devices for neurological applications,...

Report from Europe.
May 3, 2006... Report from Europe Biosite, OGeS form collaboration for colorectal cancer biomarkers A Medical Device Daily Staff Report Biosite (San Diego) and Oxford Genome Sciences (OGeS; Oxford, UK) reported forming a collaboration to evaluate...

GE's new 16-slice wide bore scanner able to image obese.
May 3, 2006... GE's new 16-slice wide bore scanner able to image obese By KAREN YOUNG Medical Device Daily Staff Writer GE Healthcare (Waukesha, Wisconsin) reported winning FDA clearance for its new wide bore computed tomography (CT) system,...

Court report.
May 3, 2006... Court report Firm charges that woman lost eye due to B&L lens solution A Medical Device Daily Staff Report A 69-year-old woman lost her eye because of her use of a contact lens solution from Bausch & Lomb (B&L; Rochester, New...

Deals roundup.
May 3, 2006... Deals roundup Media Cybernetics to purchase software developer AutoQuant A Medical Device Daily Staff Report Media Cybernetics (Silver Spring, Maryland), an image analysis software provider, has acquired the assets of AutoQuant...

Agreements roundup.
May 3, 2006... Agreements roundup Medtronic unit ends distributor accord with Vision-Sciences A Medical Device Daily Staff Writer Vision-Sciences (Natick, Massachusetts) reported the termination of its exclusive distributorship agreement, dated...

Grants/contracts.
May 3, 2006... Grants/contracts Biophan reports R&D partnering with CDRH for MRI guidelines A Medical Device Daily Staff Report Biophan Technologies (West Henrietta, New York), a developer of MRI-compatible technologies, reported a research...

Briefly Noted.
May 3, 2006... Briefly Noted In vitro diagnostics market continues rapid growth Advances in human genomics, bioinformatics, miniaturization and microelectonics -- often blended with IT and computer technology -- have led to a rapid growth spurt in...

People in Places.
May 3, 2006... People in Places * Dexanne Clohan, MD, a board-certified physical medicine and rehabilitation physician, has been named chief medical officer of HealthSouth (Birmingham, Alabama). Previously, Clohan had experience as a medical director for...

Product Briefs.
May 3, 2006... Product Briefs * Canon U.S.A. (Lake Success, New York) said it showcased the latest addition to its family of portable digital radiology (DR) systems -- the Canon CXDI-50C -- at the Society for Computer Applications in Radiology Show held...

Industry: MDUFMA2 must have clearer linkage to investment.(Medical Device User Fee and Modernization Act of 2002.)
May 4, 2006... 2nd of two articles Industry: MDUFMA2 must have clearer linkage to investment By DON LONG Medical Device Daily Managing Editor MDUFMA, the user fee program that was intended to help the FDA speed regulatory reviews, has been...

Financings roundup.
May 4, 2006... Financings roundup Home Diagnostics files for IPO seeking to raise up to $115M By HOLLAND JOHNSON Medical Device Daily Associate Managing Editor Home Diagnostics (HD; Ft. Lauderdale, Florida) reported that it has registered...

Report from Europe.
May 4, 2006... Report from Europe Metabolic 'signature' of urine could dictate drug treatment By SHARON KINGMAN Medical Device Daily Contributing Writer LONDON - The era of personalized drug therapy is inching closer, but the investigations...

Deals roundup.
May 4, 2006... Deals roundup Hologic to buy AEG for $26.56M; Serologicals closes Linco buy A Medical Device Daily Staff Report Hologic (Bedford, Massachusetts), a provider of diagnostic and digital imaging systems focused on women's health,...

Eye infection reports continue to increase and B&L responds.(Report)
May 4, 2006... Eye infection reports continue to increase and B&L responds A Medical Device Daily Staff Report The Center for Disease and Control & Prevention (CDC; Atlanta) is continuing to release data on the occurrence of fusarium keratitis eye...

Briefly Noted.
May 4, 2006... Briefly Noted BioMatrix completes new laboratory Bio-Matrix Scientific Group (San Diego), a biotechnology company focused on stem cell cryogenics and disposable stem cell/tissue transfer instruments, has completed its Medical Device...

Grants/contracts.
May 4, 2006... Grants/contracts Premier reports agreements with four spinal implant companies A Medical Device Daily Staff Report Premier (Charlotte, North Carolina) has awarded new 36-month agreements for spinal implants and related products to...

White middle-aged English healthier than those in U.S.(Survey)
May 4, 2006... Study report in JAMA: White middle-aged English healthier than those in U.S. A Medical Device Daily Staff Report White middle-aged English are healthier than their American counterparts, and in both countries lower income and...

People in Places.
May 4, 2006... People in Places * Robert deGroof, PhD, has been named chief scientific officer of Accelovance (Rockville, Maryland), a clinical services company. Before arriving at Accelovance, deGroof served as senior vice president of drug development...

Product Briefs.
May 4, 2006... Product Briefs * Nymox Pharmaceutical (Hasbrouck Heights, New Jersey) said that positive results from clinical studies of the company's AlzheimAlert test will be presented at the annual meeting of the American Psychiatric Association in...

Bioceramics offering new life to our aging organs and bones.
May 5, 2006... 1st of two stories Bioceramics offering new life to our aging organs and bones By MARK McCARTY Medical Device Daily Washington Editor WASHINGTON - While bioengineering usually tends to mean the radical reshaping of living...

Kodak hires firm to investigate Health Group 'alternatives'.
May 5, 2006... Kodak hires firm to investigate Health Group 'alternatives' A Medical Device Daily Staff Report On the heels of its report of another quarterly loss - consecutively, its sixth - Eastman Kodak (Rochester, New York) yesterday said that...

Report from Europe.
May 5, 2006... Report from Europe AGA initiates new clinical trial of migraine/heart defect link A Medical Device Daily Staff Report AGA Medical (Golden Valley, Minnesota) reported enrollment of the first patients in its newest clinical trial -...

Study: Asthma victims breathe easier with Asthmatx device.
May 5, 2006... Study: Asthma victims breathe easier with Asthmatx device By HOLLAND JOHNSON Medical Device Daily Associate Managing Editor A new surgical/device application being developed by early-stage firm Asthmatx (Mountain View, California)...

Court report.
May 5, 2006... Court report AbTox execs guilty of selling devices leading to eye damage A Medical Device Daily Staff Report The FDA reported yesterday that two executives of an Illinois company have been convicted of selling uncleared surgical...

Financings.
May 5, 2006... Financings AFP Imaging in share offering; Hanger, B&L in refinancings A Medical Device Daily Staff Report AFP Imaging (Elmsford, New York) reported that it has closed on the sale of 2.7 million shares of its common stock in a...

Deals roundup.
May 5, 2006... Deals roundup RehabCare Group to purchase Symphony Health for $101.5M A Medical Device Daily Staff Report RehabCare Group (St. Louis), a national provider of physical rehabilitation program management services, said it will acquire...

People in Places.
May 5, 2006... People in Places * Advanced BioPhotonics (Bohemia, New York), a developer of medical-imaging applications, has hired David Wright as vice president of operations. Prior to Advanced BioPhotonics, since March 2004, Wright had been director...

Siemens executives appointed to key industry leadership roles.
May 5, 2006... Siemens executives appointed to key industry leadership roles A Medical Device Daily Staff Report Siemens Medical Solutions (Malvern, Pennsylvania), a leading provider of healthcare information technology (IT) and medical imaging...

Product Briefs.
May 5, 2006... Product Briefs * Chembio Diagnostics (Medford, New York) said it has developed Dual Path Platform (DPP) technology for rapid diagnostic tests that offers significant advantages over the lateral flow technology used in commercially...

Parsortix formed with focus on non-invasive prenatal diagnosis.
May 5, 2006... Parsortix formed with focus on non-invasive prenatal diagnosis A Medical Device Daily Staff Report ANGLE Technology Ventures (Philadelphia), the U.S. technology commercialization arm of ANGLE, reported formation of its latest venture...

Bioceramics positioned for the task of bearing bigger loads.
May 8, 2006... 2nd of two articles Bioceramics positioned for the task of bearing bigger loads By MARK McCARTY Medical Device Daily Washington Editor WASHINGTON -- At present, materials scientists have not come up with "load-bearing ceramics...

Research network invests $71M to investigate rare diseases.
May 8, 2006... Research network invests $71M to investigate rare diseases By KAREN YOUNG Medical Device Daily Staff Writer The National Institutes of Health (NIH; Bethesda, Maryland) last week rolled out plans to launch the first clinical studies...

International report.
May 8, 2006... International report Welch Allyn sees 'critical mass' in Malaysia with recent add-on A Medical Device Daily Staff Report Welch Allyn (Skaneateles Falls, New York), a leading global manufacturer of frontline medical products and...

Medtronic gets FDA okay for Micro-Driver bare metal stent.
May 8, 2006... Medtronic gets FDA okay for Micro-Driver bare metal stent By HOLLAND JOHNSON Medical Device Daily Associate Managing Editor Medtronic (Minneapolis) said that it has received FDA approval for the Micro-Driver coronary stent system,...

Court report.
May 8, 2006... Court report AcerMed wins arbitration for dispute filed by MedInformatix A Medical Device Daily Staff Report AcerMed (Irvine, California) reported that it has "successfully prevailed" before the U.S. District Court in connection...

Ventilators that may suddenly stop recalled by Respironics.(Brief article)
May 8, 2006... Ventilators that may suddenly stop recalled by Respironics A Medical Device Daily Staff Report Respironics (Murrysville, Pennsylvania) on Friday reported its voluntary recall of 269 ventilators representing all models and serial...

Financings roundup.
May 8, 2006... Financings roundup Northstar prices 7.1M shares IPO to raise up to $81 million A Medical Device Daily Staff Report Northstar Neuroscience (Seattle) reported the pricing of its initial public offering of 7.1 million shares of its...

Agreements roundup.
May 8, 2006... Agreements roundup Aesthera moves to direct sales representation in southern U.S. A Medical Device Daily Staff Report Aesthera (Pleasanton, California) said it has moved to direct sales representation in four states in the southern...

Deals roundup.
May 8, 2006... Deals roundup Mesa buys Raven in $6.75M deal; HealtheTech begins shut-down A Medical Device Daily Staff Report Mesa Laboratories (Lakewood, Colorado), a manufacturer of electronic measurement instruments, reported that it has...

Grants/contracts.
May 8, 2006... Grants/contracts $4.5 million program will speed EHR uptake in California clinics A Medical Device Daily Staff Report Three healthcare foundations reported the creation of a new $4.5 million grant program to speed the adoption of...

Briefly Noted.
May 8, 2006... Briefly Noted Biolase Technology moves into new HQ Biolase Technology (Irvine, California), a manufacturer of lasers and related products focused on technologies for improved applications and procedures in dentistry and medicine,...

People in Places.
May 8, 2006... People in Places * CoreSpine Technologies (Minneapolis) has appointed John Sherman, MD, of Twin Cities Orthopedics, as medical director. CoreSpine Technologies, an emerging spinal device company, is developing enabling technologies for use...

Product Briefs.
May 8, 2006... Product Briefs * Biomet (Warsaw, Indiana), a manufacturer of products used primarily by musculoskeletal medical specialists in both surgical and non-surgical therapy, reported that the FDA has issued regulatory clearance for the company's...

Thermo, Fisher in major $10.6 billion merger.
May 9, 2006... Thermo, Fisher in major $10.6 billion merger By DON LONG Medical Device Daily Managing Editor This deal isn't as large as the merger of Guidant into Boston Scientific. But at about $10.6 billion, it's still pretty big. And it is...

Report from Israel.
May 9, 2006... Report from Israel More money following good money led by 'scope device By RAE FISHMAN Medical Device Daily Correspondent ZICHRON YAAKOV, Israel -- When you like something, you don't want to dilute it. So it is with...

Court report.
May 9, 2006... Court report Danaher, Sybron in settlement; more filings vs. Bausch & Lomb A Medical Device Daily Staff Report Danaher (Washington) and Sybron Dental Specialties (Newport Beach, California) in a joint statement said that they have...

AOA reviewing latest reports of eye infections now in 31 states.(American Optometric Association)(Report)(Brief article)
May 9, 2006... AOA reviewing latest reports of eye infections now in 31 states A Medical Device Daily Staff Report Doctors of optometry from the Contact Lens and Cornea Section of the American Optometric Association's (AOA; St. Louis) said Friday...

Financings roundup.
May 9, 2006... Financings roundup Monogram adding Pfizer $25M; Uptake takes up 'A' $9 million A Medical Device Daily Staff Report Monogram Biosciences (South San Francisco) reported that Pfizer (New York) has agreed to invest $25 million in...

Agreements roundup.
May 9, 2006... Agreements roundup Varian in pact with Drager for drug testing in U.S., Europe A Medical Device Daily Staff Report Varian (Palo Alto, California) reported a strategic relationship with Drager Safety (Lubeck, Germany) for the...

Briefly Noted.
May 9, 2006... Briefly Noted Nod to low-dose breast brachytherapy North American Scientific (NAS; Chatsworth, California) said that the Advisory Committee on the Medical Uses of Isotopes (ACMUI) to the U.S. Nuclear Regulatory Commission reviewed the...

People in Places.
May 9, 2006... People in Places * Stacey Stevens will join iCAD (Nashua, New Hampshire), a provider of computer-aided detection (CAD) solutions for the early identification of cancer, June 1 as vice president of marketing and strategy. She was most...

Calypte Bio appoints chairman, Roger Gale, as president, CEO.(Calypte Biomedical Corp.)(Brief article)
May 9, 2006... Calypte Bio appoints chairman, Roger Gale, as president, CEO A Medical Device Daily Staff Report Calypte Biomedical (Lake Oswego, Oregon), a manufacturer of diagnostic tests for the professional point-of-care and over-the-counter...

Product Briefs.
May 9, 2006... Product Briefs * BodyMedia (Pittsburgh), a provider of continuous body monitoring systems for clinical and consumer healthcare markets, said it has received another patent on the current and next generations of its wearable body monitoring...

Linked ICD/monitoring device trial launched by Medtronic.(implantable cardioverter defibrillator)
May 10, 2006... Monitoring systems merge home, physicians' offices Linked ICD/monitoring device trial launched by Medtronic By DON LONG Medical Device Daily Managing Editor Medtronic (Minneapolis) this week reported the launch of a new...

Motiva: TV-based encouragement to improve senior home self-care.
May 10, 2006... Monitoring systems merge home, physicians' offices Motiva: TV-based encouragement to improve senior home self-care By KAREN YOUNG Medical Device Daily Staff Writer Don't call it Big Brother. Just, maybe, Better Homecare. ...