Medical Device Week articles from March 2005

Medical Device Week archives from March 2005

From politics to CAOS-surgery, meeting hits range of issues.(computer-assisted orthopedic surgery)
March 1, 2005... AAOS annual meeting From politics to CAOS-surgery, meeting hits range of issues By CHRISTOPHER DELPORTE Medical Device Daily Washington Editor WASHINGTON - With the annual meeting of the American Academy of Orthopaedic...

Cook Biotech, CorMatrix form cardio biomaterials license pact.
March 1, 2005... Cook Biotech, CorMatrix form cardio biomaterials license pact By HOLLAND JOHNSON Medical Device Daily Associate Managing Editor Cook Biotech (West Lafayette, Indiana) and CorMatrix Cardiovascular (Marietta, Georgia) reported that...

Report from Europe.
March 1, 2005... Report from Europe NICE supports dual-chamber pacing in England and Wales A Medical Device Daily Staff Report In new medical guidance for England and Wales, the National Institute for Clinical Excellence (NICE; Watford, England) is...

Financings roundup.
March 1, 2005... Financings roundup Perlegen raises private $74M; Sciona garners $8.2 million A Medical Device Daily Staff Report New applications for advanced research in genomic technology will be supported by recent fund-raising reported on...

Court report.
March 1, 2005... Court report 'Whistleblower' suit alleges defective HP medical devices A Medical Device Daily Staff Report Citing a "scheme to defraud its customers by selling defective and potentially dangerous medical devices," an amended...

New products, agreements are rolled out by GE Healthcare.
March 1, 2005... AAOS notebook New products, agreements are rolled out by GE Healthcare A Medical Device Daily Staff Report Matching its size and diversity of development, GE Healthcare (Waukesha, Wisconsin) unveiled a variety of new products and...

Class I recalls are issued for Lifepak AEDs, catheter flushes.
March 1, 2005... Class I recalls are issued for Lifepak AEDs, catheter flushes A Medical Device Daily Staff Report Medtronic (Redmond, Washington) reported voluntarily recalling "a limited number" of Lifepak 500 automated external defibrillators...

Deals roundup.
March 1, 2005... Deals roundup Medstat buys two healthcare product lines from Solucient A Medical Device Daily Staff Report Medstat (Ann Arbor, Michigan) reported that it has purchased two strategic healthcare payer product lines, Champ and...

Briefly Noted.
March 1, 2005... Briefly Noted New facility for Rockwell Medical Rockwell Medical Technologies (Wixom, Michigan), a manufacturer of hemodialysis concentrate, reported leasing a "turnkey" concentrate manufacturing facility in Hodges, South Carolina,...

People in Places.
March 1, 2005... People in Places * David Phillips has been appointed vice president of marketing for HemoSense (San Jose, California), responsible for developing marketing initiatives in support of HemoSense's INRatio Prothrombin Time Monitoring System, a...

Product Briefs.
March 1, 2005... Product Briefs * Candela (Wayland, Massachusetts) reported receiving FDA clearance for its family of pulsed dye lasers for the treatment of benign epidermal pigmented lesions. The clearance adds to the previously cleared indications for...

Washington Roundup.
March 2, 2005... Washington Roundup CDRH: MDUFMA 1Q05 results include increased workload By CHRISTOPHER DELPORTE Medical Device Daily Washington Editor WASHINGTON - The FDA's Center for Devices and Radiological Health (CDRH) recently released...

Grants/contracts.
March 2, 2005... Grants/contracts Inverness to do biomarker R&D via $57M from Scottish initiative By KAREN YOUNG Medical Device Daily Staff Writer Inverness Medical Innovations (Waltham, Massachusetts), a manufacturer of rapid diagnostic...

Report from Europe.
March 2, 2005... Report from Europe ECRIS is established to study intraoperative radiotherapy A Medical Device Daily Staff Report Intraop Medical (Santa Clara, California) reported the creation of a new European body to study intraoperative...

Deals roundup.
March 2, 2005... Deals roundup Viasys adds neurodiagnostics via buy of Oxford unit for $46M A Medical Device Daily Staff Report Viasys Healthcare (Conshohocken, Pennsylvania) reported acquiring the global Medical Division (Woking, UK) of Oxford...

Thermo Electron rolls out new lab, drug discovery offerings.
March 2, 2005... PITTCON 2005 Thermo Electron rolls out new lab, drug discovery offerings A Medical Device Daily Staff Report Analytical instrument developer Thermo Electron (Waltham, Massachusetts) unveiled new laboratory solutions this week at...

Financings roundup.
March 2, 2005... Financings roundup Atherotech adds $7.5 million via line-of-credit, plus loan A Medical Device Daily Staff Report Atherotech (Birmingham, Alabama), a developer of cardio-diagnostic technology, reported receiving $7.5 million in...

Companies laud U.S. PTO move to reject Pharmastem claims.
March 2, 2005... Patent news Companies laud U.S. PTO move to reject Pharmastem claims A Medical Device Daily Staff Report ThermoGenesis (Rancho Cordova, California), a supplier of cryogenic devices used by cord blood banks, and Netcord (Dusseldorf,...

People in Places.
March 2, 2005... People in Places * Joseph Farmer has been appointed general counsel and vice president of legal affairs for Advanced Magnetics (Cambridge, Massachusetts). Farmer will assume the responsibilities of Rachel Konforty, who will continue with...

King named president and CEO of Thomson Healthcare.(Brief Article)
March 2, 2005... King named president and CEO of Thomson Healthcare A Medical Device Daily staff report Kevin King has been named president and CEO of Thomson Healthcare (Montvale, New Jersey), effective March 8. King joins Thomson, the parent company...

Product Briefs.
March 2, 2005... Product Briefs * Iridex (Mountain View, California) reported a "significant" clinical benefit in a subset of patients with wet age-related macular degeneration (AMD) treated with the transpupillary thermotherapy (TTT) laser protocol when...

Study reports falling confidence by consumers in FDA oversight.(Food and Drug Administration)
March 3, 2005... Study reports falling confidence by consumers in FDA oversight By CHRISTOPHER DELPORTE Medical Device Daily Washington Editor WASHINGTON - A recent poll shows that consumer confidence in the FDA's ability to ensure product safety...

Xtent gathers new $25M round for multiple stenting system.
March 3, 2005... Xtent gathers new $25M round for multiple stenting system By DON LONG Medical Device Daily Managing Editor Xtent (Menlo Park, California) - a developer of stent systems for delivering multiple stents and drug-eluting stent (DES)...

International Report.
March 3, 2005... International report Bone mineral density database is developed by GE in China A Medical Device Daily Staff Report GE Healthcare (Waukesha, Wisconsin) said it has developed the largest bone mineral density reference database in the...

GenVec, Cordis in launch of Phase IIb trial for BioBypass.
March 3, 2005... GenVec, Cordis in launch of Phase IIb trial for BioBypass By HOLLAND JOHNSON Medical Device Daily Associate Managing Editor GenVec (Gaithersburg, Maryland) reported the launch of a Phase IIb randomized, placebo-controlled trial of...

Court Report.
March 3, 2005... Court report Securities class actions filed vs. ANS and EPIX Pharmaceuticals A Medical Device Daily Staff Report Two shareholder class actions have been filed in Texas courts vs. Advanced Neuromodulation Systems (ANS; Dallas), a...

Abbott Northwestern Heart Hospital dedicated.(Brief Article)
March 3, 2005... Abbott Northwestern Heart Hospital dedicated The Abbott Northwestern's Heart Hospital, located on its Minneapolis, Minnesota, campus, was dedicated this week. The Heart Hospital will provide new, expanded space for cardiovascular services,...

Deals Roundup.
March 3, 2005... Deals roundup Franklin closes SurgiCount buy; Elekta, Impac file for merger A Medical Device Daily Staff Report Franklin Capital (Santa Monica, California) reported that it has completed its previously disclosed purchase of...

Financing Roundup.
March 3, 2005... Financing roundup Spine company Axial Biotech garners Series A round of $4.1M A Medical Device Daily Staff Report Axial Biotech (Salt Lake City) reported completing a Series A round of financing, raising $4.1 million. Axial is...

InSight receives JCAHO accreditation.(Brief Article)
March 3, 2005... InSight receives JCAHO accreditation InSight Health Services (Lake Forest, California) reported that its subsidiary, InSight Health, has received from the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) the Gold Seal...

Briefly Noted.
March 3, 2005... Briefly Noted Baxter to purchase Red Cross plasma Baxter Healthcare (Deerfield, Illinois) and the American National Red Cross (Washington) reported that they have signed a new, long-term plasma procurement contract. Under this new...

People in Places.
March 3, 2005... People in Places * Stephen Sagon has been named president and CEO of CardioFocus (Norton, Massachusetts). Sagon will also serve as a director. Jeffrey Arnold, chairman and former president and CEO, will remain with the company as chairman....

Product Briefs.
March 3, 2005... Product Briefs * Mediware Information Systems (Lenexa, Kansas), a provider of healthcare delivery and patient safety software management solutions, said it has submitted its next-generation hospital donor management system, HCLL Donor, to...

Panel: In order to avoid pitfalls, start reimbursement drive early.
March 4, 2005... AdvaMed 2005 annual meeting Panel: In order to avoid pitfalls, start reimbursement drive early By JIM STOMMEN Medical Device Daily Executive Editor DANA POINT, California - The road to reimbursement is long and twisting for...

Cardiac Science, Quinton seek merger but suit filed to block.
March 4, 2005... Cardiac Science, Quinton seek merger but suit filed to block By HOLLAND JOHNSON Medical Device Daily Associate Managing Editor Cardiac Science (Irvine, California), a maker of automatic public-access automated external...

Report from Europe.
March 4, 2005... Report from Europe Medical Device Innovations adds [pounds sterling]2.9 million in Series A round A Medical Device Daily Staff Report Medical Device Innovations (MDi; Chester, UK), an intellectual property development company...

VivoMetrics' LifeShirt monitors athletes' mood vs. performance.
March 4, 2005... VivoMetrics' LifeShirt monitors athletes' mood vs. performance By KIM URQUHART A Medical Device Daily Staff Writer Athletes strive to win, and they thrive on competition. But does mood - like feelings of frustration during a race...

Washington Roundup.
March 4, 2005... Washington Roundup Reporter's death sparks larger awareness of risk from DVT By CHRISTOPHER DELPORTE Medical Device Daily Washington Editor WASHINGTON - U.S. senators unanimously passed a resolution Wednesday in an effort to...

Financings roundup.
March 4, 2005... Financings roundup Refocus Group swings deals for potential $18M in new financing A Medical Device Daily Staff Report Refocus Group (Dallas), which develops treatments for eye disorders, reported the closing of the first half of a...

Deals roundup.
March 4, 2005... Deals roundup PaperFree buys KMS Computer; Kensey, Orthovita in tissue pact A Medical Device Daily Staff Report PaperFree Medical Solutions (PMS; Scottsdale, Arizona) reported closing on the acquisition of KMS Computer Services...

Court report.
March 4, 2005... Court report Florida files separate lawsuits vs. Tenet and unlicensed doc A Medical Device Daily Staff Report Charlie Crist, the attorney general for the State of Florida has filed a lawsuit against Tenet Healthcare (Dallas),...

AdvaMed to continue push on accelerating approvals.
March 4, 2005... AdvaMed to continue push on accelerating approvals DANA POINT, California - Delivering her annual "AdvaMed priorities" speech on the opening day of this year's annual meeting of the Advanced Medical Technologies Association (AdvaMed;...

Product Briefs.
March 4, 2005... Product Briefs * Global Medical Research (Orlando, Florida), which said it is developing intellectual property that addresses problems in the biomedical field, reported the launch of technology designed to prevent post surgical adhesions....

McClellan sees CMS, industry partnering in innovation push.(Centers for Medicare & Medicaid Services)
March 7, 2005... AdvaMed 2005 Annual Meeting McClellan sees CMS, industry partnering in innovation push By JIM STOMMEN Medical Device Daily Executive Editor DANA POINT, California - The Friday morning link-up may have been by videoconference,...

Panel: Embrace compliance, because 'they're out to get you'.
March 7, 2005... AdvaMed 2005 Annual Meeting Panel: Embrace compliance, because 'they're out to get you' By JIM STOMMEN Medical Device Daily Executive Editor DANA POINT, California - Memo to medical device company executives: They're out to...

Report from Europe.
March 7, 2005... Report from Europe NHS [pounds sterling]1 billion in new funding will support faster diagnostics A Medical Device Daily Staff Report National Health Service patients should get faster access to high quality diagnostic tests in the...

J&J to acquire Closure Medical in $370M cash-and-stock deal.(Johnson & Johnson )
March 7, 2005... J&J to acquire Closure Medical in $370M cash-and-stock deal A Medical Device Daily Staff Report Further expanding its franchise in the adhesives sector, medical products Goliath Johnson & Johnson (J&J; New Brunswick, New Jersey) has...

FDA 'action' looming for Staar, 'strategic alternatives' sought.
March 7, 2005... FDA 'action' looming for Staar, 'strategic alternatives' sought By DON LONG Medical Device Daily Managing Editor and Holland Johnson MDD Associate Managing Editor Troubled ophthalmic manufacturer Staar Surgical (Monrovia,...

Two neuromodulation tech firms report on early study results.
March 7, 2005... Two neuromodulation tech firms report on early study results By HOLLAND JOHNSON Medical Device Daily Associate Managing Editor Two companies developing implantable neuromodulation technology systems reported results yesterday from...

Vote against Combidex hurts Cytogen, Advanced Magnetics.
March 7, 2005... Vote against Combidex hurts Cytogen, Advanced Magnetics By AARON LORENZO Medical Device Daily Staff Writer WASHINGTON - Stock values plummeted for the companies behind the molecular imaging agent Combidex (ferumoxtran-10),...

Court report.
March 7, 2005... Court report BioGenex files separate action vs. Ventana in ongoing dispute A Medical Device Daily Staff Report BioGenex (San Ramon, California) reported filing a lawsuit in the U.S. District Court for the Northern District of...

Deals roundup.
March 7, 2005... Deals roundup Kodak completes Orex purchase; Kendro acquisition FTC-cleared A Medical Device Daily Staff Report Eastman Kodak (Rochester, New York) reported the completion of its acquisition of Orex Computed Radiography (Yokneam,...

Pall enters purified water field with new Cascada Lab systems.(Brief Article)
March 7, 2005... Pall enters purified water field with new Cascada Lab systems A Medical Device Daily Staff Report Pall (East Hills, New York) said it is bringing its water purification expertise to the laboratory market with the introduction of the...

Animas receives FDA warning following facility inspection.(Brief Article)
March 7, 2005... Animas receives FDA warning following facility inspection A Medical Device Daily Staff Report Insulin pump manufacturer Animas (West Chester, Pennsylvania) reported that it received a warning letter last week from the Philadelphia...

Product Briefs.
March 7, 2005... Product Briefs * Vasomedical (Westbury, New York), focused on the non-invasive treatment and management of cardiovascular diseases, said that results of its PEECH (Prospective Evaluation of EECP in Congestive Heart Failure) trial will be...

People in Places.
March 7, 2005... People in Places * Zach Hall, PhD, will serve as interim president and senior science advisor of the California Institute for Regenerative Medicine (Emeryville, California) for one year while a formal search to find a permanent president...

Cypher scores vs. Taxus, but many more rounds yet to go.
March 8, 2005... American College of Cardiology Scientific Sessions Cypher scores vs. Taxus, but many more rounds yet to go By DON LONG Medical Device Daily Managing Editor ORLANDO, Florida - The Oscar-winning movie "Million Dollar Baby" has...

Drugs sometimes aid device therapies, sometimes don't.
March 8, 2005... American College of Cardiology Scientific Sessions Drugs sometimes aid device therapies, sometimes don't By DON LONG Medical Device Daily Managing Editor ORLANDO, Florida - Drug/device combinations clearly are beneficial, as...

Report from Europe.
March 8, 2005... Report from Europe Three anesthesiology groups merge into a single society A Medical Device Daily Staff Report The merger of three European anesthesiology organizations into a single group, the European Society of Anesthesiology...

NewTek expected to provide ease in glucose monitoring.
March 8, 2005... NewTek expected to provide ease in glucose monitoring By KAREN YOUNG Medical Device Daily Staff Writer Add to the already extensive list of alternatives for glucose monitoring the NewTek, a new product from Hypoguard (Minneapolis),...

Companies large and small show range of new products.
March 8, 2005... ACC products Companies large and small show range of new products A Medical Device Daily Staff Report ORLANDO, Florida - The annual scientific sessions of the American College of Cardiology (ACC; Bethesda, Maryland) feature the...

Positive trial results cited for Conor, Medtronic stents.
March 8, 2005... ACC notebook Positive trial results cited for Conor, Medtronic stents A Medical Device Daily Staff Report William Wijns, MD, co-principal investigator of the ENDEAVOR II pivotal clinical trial of Medtronic's (Minneapolis) Endeavor...

Deals roundup.
March 8, 2005... Deals roundup Solexa, Lynx complete merger; TLC Vision adopts rights plan A Medical Device Daily Staff Report Solexa Ltd. (Cambridge, UK) and Lynx Therapeutics (Hayward, California) reported the completion of their previously...

Briefly Noted.
March 8, 2005... Briefly Noted Toshiba selects CyberGuard for scanner access CyberGuard (Boca Raton, Florida), a global provider of security solutions that it said "protect the critical components of the largest and most complex information networks...

CDC asks public to weigh in on new research agenda.
March 8, 2005... CDC asks public to weigh in on new research agenda A Medical Device Daily Staff Report The Centers for Disease Control and Prevention (CDC), along with the Agency for Toxic Substance and Disease Registry (ATSDR; both Atlanta), reported...

Financings roundup.
March 8, 2005... Financings roundup Nanomix closes on $16 million; Matritech in placement accord A Medical Device Daily Staff Report Nanomix (Emeryville, California), a nanotechnology company commercializing a line of nanoelectronic detection...

People in Places.
March 8, 2005... People in Places * Thierry Thaure has been appointed CEO of EsophyX (Redmond, Washington), a manufacturer of single-use ins-truments that will enable incisionless solutions to gastroesophageal reflux disease and other functional upper...

Product Briefs.
March 8, 2005... Product Briefs * Archus Orthopedics (Redmond, Washington) said it has received CE mark approval of its Total Facet Arthroplasty System (TFAS). The spinal implant is designed to treat spinal stenosis, a condition in which degenerative...

CARE-HF study boosts CRT as potential cardio 'Nirvana'.(cardiac resynchronization therapy )
March 9, 2005... American College of Cadiology Scientific Sessions CARE-HF study boosts CRT as potential cardio 'Nirvana' By DON LONG Medical Device Daily Managing Editor ORLANDO, Florida - CRT - or cardiac resynchronization therapy - works....

Monitoring, diagnostics tech get wide-spectrum showcasing.
March 9, 2005... American College of Cadiology Scientific Sessions Monitoring, diagnostics tech get wide-spectrum showcasing By DON LONG Medical Device Daily Managing Editor ORLANDO, Florida - The beauty of a conference with the breadth and...

Lots of dialogue being heard about device deals, financings.
March 9, 2005... AdvaMed 2005 annual meeting Lots of dialogue being heard about device deals, financings By JIM STOMMEN Medical Device Daily Executive Editor DANA POINT, California - Even the most casual observer can sense that there's an...

diaDexus eyes 510(k) approval of PLAC test for stroke risk.
March 9, 2005... diaDexus eyes 510(k) approval of PLAC test for stroke risk By KAREN YOUNG Medical Device Daily Staff Writer diaDexus (South San Francisco, California) is going for a second use for its PLAC test, which is now used to predict the...

Report from Israel.
March 9, 2005... Report from Israel Eckhouse, Syneron push further into green with sale of stock By RAE FISHMAN Medical Device Daily Correspondent ZICHRON YA'AKOV, Israel - The largest stock sale offering in the past five years by an Israeli...

Study cites advances with Evalve's mitral valve clip.
March 9, 2005... ACC notebook Study cites advances with Evalve's mitral valve clip A Medical Device Daily Staff Report ORLANDO, Florida - Companies continued to roll out a large array of new products at the American College of Cardiology's (ACC;...

Financings roundup.
March 9, 2005... Financings roundup Cadent raises $25 million; Miravant in $15M credit line A Medical Device Daily Staff Report Cadent Holdings (Carlstadt, New Jersey), a developer of digital technology and services for use in the orthodontic and...

Deals roundup.
March 9, 2005... Deals roundup Cytyc completes Proxima buy; Fisher to sell Atos Medical A Medical Device Daily Staff Report Women's health company Cytyc (Marlborough, Massachusetts) reported that it has closed on the acquisition of privately held...

People in Places.
March 9, 2005... People in Places * Antonius Schuh, PhD, has been appointed CEO of Arcturus Bioscience (Mountain View, California) and will be elected a member of the board of directors. Schuh succeeds Thomas Baer, PhD, founder and former CEO, who resigned...

Pamela Douglas is installed as new president of ACC.(American College of Cardiology)
March 9, 2005... Pamela Douglas is installed as new president of ACC ORLANDO, Florida - Pamela Douglas, MD, described by the American College of Cardiology (ACC; Bethesda, Maryland) as "a well-known leader in the cardiovascular community," has been...

Product Briefs.
March 9, 2005... Product Briefs * OccuLogix (Toronto), which is developing rheopheresis, an advanced form of plasma therapy called membrane differential filtration, reported that the FDA has completed a review of the long-term efficacy in age-related...

Philips emphasizes integration to speed cath lab procedures.(Royal Philips Electronics )
March 10, 2005... American College of Cardiology Scientific Sessions Philips emphasizes integration to speed cath lab procedures By DON LONG Medical Device Daily Managing Editor ORLANDO, Florida - The Orange County Convention Center on...

Range of device, drug-related work put on meeting's radar.
March 10, 2005... American College of Cardiology Scientific Sessions Range of device, drug-related work put on meeting's radar By DON LONG Medical Device Daily Managing Editor ORLANDO, Florida - Medical Device Daily, quite obviously, focuses on...

Parallel FDA/CMS reviews? Bring them on, says Schultz.
March 10, 2005... AdvaMed 2005 annual meeting Parallel FDA/CMS reviews? Bring them on, says Schultz By JIM STOMMEN Medical Device Daily Executive Editor DANA POINT, California - No one who listened to Daniel Schultz, MD, director of the FDA's...

Accumetrics' aspirin resistance test available in new version.
March 10, 2005... Accumetrics' aspirin resistance test available in new version By KAREN YOUNG Medical Device Daily Staff Writer Accumetrics (San Diego) President and CEO Rob Hillman says there are about 25 million people on an aspirin regimen to...

Report from Europe.
March 10, 2005... Report from Europe UK eyes greater regulation of accupuncture, herbal medicine A Medical Device Daily Staff Report A new UK government report suggests that more than nine out of 10 practitioners, patient groups and members of the...