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Researcher's 'science fiction' theories bring medical realities.
May 2, 2005... Researcher's 'science fiction' theories bring medical realities
By CHRISTOPHER DELPORTE
Medical Device Daily Washington Editor
WASHINGTON - Imagine polymers and cells engineered to come together and create almost any kind of...
IT vendors don't want to be left behind in new EHR effort.(electronic health record)
May 2, 2005... HIMSS sets 'plan of attack'
IT vendors don't want to be left behind in new EHR effort
By DON LONG
Medical Device Daily Managing Editor
The Healthcare Information and Management Systems Society (HIMSS; Chicago) is taking still...
International report.
May 2, 2005... International report
MedMira completes registration for its test products in UAE
A Medical Device Daily Staff Report
MedMira (Halifax, Nova Scotia) a developer of rapid flow-through diagnostic technology, said it has successfully...
Cook's AFP fistula plug is 1st cleared fistula repair device.
May 2, 2005... Cook's AFP fistula plug is 1st cleared fistula repair device
By HOLLAND JOHNSON
Medical Device Daily Associate Managing Editor
The FDA has cleared Cook Biotech's (West Lafayette, Indiana) Surgisis AFP fistula plug, which the...
Financings roundup.
May 2, 2005... Financings roundup
Luminetx gets 1st-round $4M; Fisher prices its tender offer
A Medical Device Daily Staff Report
Hoping to put a larger developmental light on its flagship product, the VeinViewer, Luminetx (Memphis, Tennessee) on...
Court report.
May 2, 2005... Court report
License granted Axis-Shield in patent claims settlement
A Medical Device Daily Staff Report
Competitive Technologies (CTT; Fairfield, Connecticut) reported that a homocysteine assay license has been granted to...
Deals roundup.
May 2, 2005... Deals roundup
Siemens reports on offers; Motion DNA okays buyout
A Medical Device Daily Staff Report
Siemens Medical Solutions USA (Hoffman Estates, Illinois), a wholly owned subsidiary of Siemens (Erlangen, Germany), reported the...
Briefly Noted.
May 2, 2005... Briefly Noted
J-V creates Bay Area Surgical Ventures
National Surgical Hospitals (NSH; Chicago), an operator of freestanding specialty surgical hospitals and surgery centers, has formed a joint venture with John Muir/ Mt. Diablo Health...
People in Places.
May 2, 2005... People in Places
* Oscar Amparan has been named president of Arlington Memorial Hospital (Arlington, Texas), replacing Wayne Clark, who retired earlier this year. He also will serve as executive vice president of Texas Health Resources...
Grants/contracts.
May 2, 2005... Grants/contracts
MFSI signs CRADA for its sample-processing products
A Medical Device Daily Staff Report
MicroFluidic Systems (MFSI; Pleasanton, California) has signed a cooperative research and development agreement (CRADA) with...
Product Briefs.
May 2, 2005... Product Briefs
* Boston Scientific (Natick, Massachusetts) reported one-year data from its carotid artery stenting (CAS) clinical trial, BEACH. The study evaluates the effectiveness of stenting with embolic protection for patients who are...
IQLM pursues a separate lab report card at 1st conference.(Institute for Quality in Laboratory Medicine)
May 3, 2005... IQLM pursues a separate lab report card at 1st conference
BY KAREN YOUNG
Medical Device Daily Staff Writer
ATLANTA - The Institute for Quality in Laboratory Medicine (IQLM) met for the first time as a group here last Thursday,...
Financings roundup.
May 3, 2005... Financings roundup
Neurologix, Medtronic in joint gene therapy catheter effort
By HOLLAND JOHNSON
Medical Device Daily Associate Managing Editor
Neurologix (Fort Lee, New Jersey) said it has entered into an agreement with...
Report from Europe.
May 3, 2005... Report from Europe
Puusepp advances to CEO at Elekta; Leksell has new focus
A Medical Device Daily Staff Report
As part of a leadership succession plan announced by Elekta (Stockholm, Sweden) last fall, Tomas Puusepp has assumed...
Washington roundup.(medical equipment industry)
May 3, 2005... Washington roundup
Poll says Americans concerned about losing health insurance
By CHRISTOPHER DELPORTE
Medical Device Daily Washington Editor
WASHINGTON - With the release of a national poll that seems to show strong support...
Deals roundup.
May 3, 2005... Deals roundup
GSK in agreement to acquire Corixa in deal valued at $300M
A Medical Device Daily Staff Report
Major global pharma firm GlaxoSmithKline (GSK; London) said Friday it had executed a definitive agreement under which it...
Grants/contracts.
May 3, 2005... Grants/contracts
Genzyme in license agreement with MGH and Dana-Farber
A Medical Device Daily Staff Report
Genzyme (Cambridge, Massachusetts) said it has entered a license agreement with Massachusetts General Hospital (MGH; Boston)...
RITA moves headquarters.(Brief Article)
May 3, 2005... RITA moves headquarters
RITA Medical Systems (Fremont, California), which focuses on medical oncology devices, said the company's headquarters were relocated to Fremont from its previous location in Mountain View, effective Monday. The...
New group conducts quality survey with CLMA members.(Clinical Laboratory Management As-sociation)
May 3, 2005... New group conducts quality survey with CLMA members
As one of its starting points, the Institute for Quality in Laboratory Medicine (IQLM) commissioned a survey conducted by the Clinical Laboratory Management As-sociation (CLMA; Wayne,...
Briefly Noted.
May 3, 2005... Briefly Noted
West Coast office for BioElectronics
BioElectronics (Frederick, Maryland) reported the opening of a sales and marketing office in Westlake Village, California, to sell its FDA-cleared ActiPatch Therapy.
The Los...
People in Places.
May 3, 2005... People in Places
* Ronald Rosenberg has joined LehmanMillet (Boston), an international marketing communications firm for the medical device and diagnostic marketplace, as manager of public and professional relations. A business and...
Product Briefs.
May 3, 2005... Product Briefs
* CeMines (Golden, Colorado) said results from an expanded study of more than 200 lung cancer patient samples confirmed key data initially presented in February at the American Association of Cancer Research's Special...
Broadened scientific program, economic issues in spotlight.
May 4, 2005... Heart Rhythm 2005
Broadened scientific program, economic issues in spotlight
By CHRISTOPHER DELPORTE
Medical Device Daily Washington Editor
NEW ORLEANS - Rhythm often comes to mind when you think of New Orleans - smooth jazz,...
Financings roundup.
May 4, 2005... Financings roundup
Sound Surgical, EpiCept unveil IPO share numbers and pricing
A Medical Device Daily Staff Report
Sound Surgical Technologies (Louisville, Kentucky) has filed a registration statement with the Securities and...
Report from Europe.
May 4, 2005... Report from Europe
Misonix products okayed for sale in Russian Federation
A Medical Device Daily Staff Report
Misonix (Farmingdale, New York), a developer of ultrasonic technology for the treatment of cancer and other healthcare...
Cleveland Clinic researchers get blood-brain test patent.
May 4, 2005... Cleveland Clinic researchers get blood-brain test patent
By HOLLAND JOHNSON
Medical Device Daily Associate Managing Editor
Researchers at the Cleveland Clinic (Cleveland) reported that they have received a U.S. patent for...
Valley Forge and Synergetics disclose agreement to merge.
May 4, 2005... Valley Forge and Synergetics disclose agreement to merge
A Medical Device Daily Staff Report
Valley Forge Scientific (Oaks, Pennsylvania) and Synergetics (St. Charles, Missouri) reported entering into a stock-based merger agreement,...
Court report.
May 4, 2005... Court report
LMA charges that Tyco unit infringes upon its mask patent
A Medical Device Daily Staff Report
LMA International, through its wholly owned subsidiary, LMA Deutschland (Munich, Germany/San Diego), has filed a patent...
Laerdal in recall of adapter cable for Heartstart defibs.(Brief Article)
May 4, 2005... Laerdal in recall of adapter cable for Heartstart defibs
A Medical Device Daily Staff Report
Laerdal Medical Corp. (Wappingers Falls, New York) said last week that it has initiated a voluntary recall of all lots of its CM...
Deals roundup.
May 4, 2005... Deals roundup
ICU buys Salt Lake City facility from Hospira for $32M in cash
A Medical Device Daily Staff Report
ICU Medical (San Clemente, California), a manufacturer of medical connectors and intravenous systems, reported...
Grants/contracts news.
May 4, 2005... Grants/contracts news
Correlogic collaboration eyes prostate cancer blood test
A Medical Device Daily Staff Report
Correlogic Systems (Bethesda, Maryland) reported a research collaboration with the Uniformed Services University of...
Product Briefs.
May 4, 2005... Product Briefs
* Coapt Systems (Palo Alto, California), a manufacturer of bioabsorbable implants for the fixation of soft tissue in the plastic and reconstructive surgery markets, reported that it has released the Endotine Midface Bone 4.5...
Only 'relative risk reduction' for at-risk patients with ICDs.(implantable cardioverter defibrillators)
May 5, 2005... Heart Rhythm 2005
Only 'relative risk reduction' for at-risk patients with ICDs
By CHRISTOPHER DELPORTE
Medical Device Daily Washington Editor
NEW ORLEANS - Cardiologists shouldn't be in such a rush to use implantable...
Fresenius to grow even larger with $3.5B deal for Renal Care.
May 5, 2005... Fresenius to grow even larger with $3.5B deal for Renal Care
A Medical Device Daily Staff Report
Fresenius Medical Care (Bad Homburg, Germany), already having a major share of the world's dialysis services sector and a manufacturer of...
International report.
May 5, 2005... International report
CABG Medical enrolls first patient in Holly Graft trial
A Medical Device Daily Staff Report
Enrollment has begun in CABG Medical's (Minneapolis) clinical trial for CE mark approval of the Holly Graft System, a...
Split Rock raises $275M for first fund; Canaan adds $450M.
May 5, 2005... Split Rock raises $275M for first fund; Canaan adds $450M
By JIM STOMMEN
Medical Device Daily Executive Editor
Two venture capital firms have reported the closing of new funds that feature a significant focus on medical technology....
Deals roundup.
May 5, 2005... Deals roundup
Genzyme in $600M buy of BCI; AMO exercises Quest option
A Medical Device Daily Staff Report
Genzyme (Cambridge, Massachusetts) has signed a merger agreement to acquire Bone Care International (BCI; Madison, Wisconsin)...
Financings roundup.
May 5, 2005... Financings roundup
HTG in $3.4 million 'B' round; Paradigm sells secured notes
A Medical Device Daily Staff Report
HTG (Tucson), a provider of array-based gene expression assay technology and services to the life sciences...
ELA reports FDA product okay to block unnecessary pacing.
May 5, 2005... HRS notebook
ELA reports FDA product okay to block unnecessary pacing
A Medical Device Daily Staff Report
ELA Medical (Arvada, Colorado), a business of the Sorin Group (Milano, Italy) that develops cardiac rhythm management and...
Grants/contracts news.
May 5, 2005... Grants/contracts news
Cardinal licenses Axeda's DRM technology for Pyxis
A Medical Device Daily Staff Report
Cardinal Health (Dublin, Ohio), a provider of products and services supporting healthcare, has licensed technology from...
Briefly Noted.
May 5, 2005... Briefly Noted
TriVirix engineering center moves
TriVirix (Durham, North Carolina) said that its Engineering Services Design and Development Center of Excellence has moved from its location in Indianapolis to a new facility in nearby...
People in Places.
May 5, 2005... People in Places
* Raymond Fabius, MD, has been named president and chief medical officer of I-trax (Chadds Ford, Pennsylvania). Prior to joining I-trax, Fabius was with GE Healthcare. I-trax is a provider of integrated health and...
Court report.
May 5, 2005... Court report
Veridian: Whistleblower suit concerning its tests 'baseless'
A Medical Device Daily Staff Report
VeridianHealth (Deerfield, Illinois), a provider of electrodiagnostic nerve testing services to physicians' offices,...
Product Briefs.
May 5, 2005... Product Briefs
* AGA Medical (Minneapolis) said it would present an update on its RESPECT clinical trial, plus an in-depth examination of the issues facing clinicians who treat patent foramen ovale (PFO) patients affected by stroke, during...
Futurist: pessimism for drugs, good value seen in devices.(health care industry forecasts)
May 6, 2005... Heart Rhythm 2005
Futurist: pessimism for drugs, good value seen in devices
By CHRISTOPHER DELPORTE
Medical Device Daily Washington Editor
NEW ORLEANS - It would be difficult to come to almost any kind of healthcare conference...
Vasomedical pares down staff, but is moving forward in CHF.
May 6, 2005... Vasomedical pares down staff, but is moving forward in CHF
By DON LONG
Medical Device Daily Managing Editor
The word "realignment" usually indicates bad news.
But realignment can also be a bad news/good news kind of story,...
Report from Europe.
May 6, 2005... Report from Europe
Researchers tell of possible new breast cancer biomarkers
A Medical Device Daily Staff Report
Scientists from a joint research study conducted by Applied Biosystems Group (Foster City, California) and the...
Fujirebio's mesothelioma test is under review by the FDA.
May 6, 2005... Fujirebio's mesothelioma test is under review by the FDA
By KAREN YOUNG
Medical Device Daily Staff Writer
Fujirebio Diagnostics (FDI; Malvern, Pennsylvania) has submitted a 510(k) application to the FDA for clearance of Mesomark,...
Guidant reports 'conditional' IDE approval for DES trial.(drug-eluting stent)(investigational device exemption)
May 6, 2005... Guidant reports 'conditional' IDE approval for DES trial
By DON LONG
Medical Device Daily Managing Editor
Long standing in the wings as other players have snared starring roles in the drug-eluting stent (DES) sector in the U.S.,...
Dynacq shares listed on Nasdaq.(Brief Article)
May 6, 2005... Dynacq shares listed on Nasdaq
Holding company Dynacq Healthcare (Houston) said that Nasdaq has approved its application for its common stock to be listed on the Nasdaq SmallCap Market. The shares began trading Tuesday under the trading...
Deals roundup.
May 6, 2005... Deals roundup
Regal One buys ASC to boost its opportunities in stem cells
A Medical Device Daily Staff Report
Regal One (Los Angeles) reported that it recently acquired a 10% interest in Nevada-based American Stem Cell (ASC) - the...
Biophan cites study findings clarifying MRI safety reports.
May 6, 2005... HRS notebook
Biophan cites study findings clarifying MRI safety reports
A Medical Device Daily Staff Report
Biophan Technologies (West Henrietta, New York) reported the results of its recent scientific studies that it said help...
Maryland county selects Cardiac Science AEDs.(Brief Article)
May 6, 2005... Maryland county selects Cardiac Science AEDs
Cardiac Science (Irvine, California), a manufacturer of automatic external defibrillators (AEDs), and Baltimore County jointly reported that Cardiac Science had been named its exclusive marketing...
Product Briefs.
May 6, 2005... Product Briefs
* Intraop Medical (Santa Clara, California), manufacturer of the Mobetron, a mobile electron beam system designed for intraoperative radiotherapy (IORT) treatment, said that according to research presented in March at the...
Better management, reducing admissions can trim AF costs.(atrial fibrillation)
May 9, 2005... Heart Rhythm 2005
Better management, reducing admissions can trim AF costs
By CHRISTOPHER DELPORTE
Medical Device Daily Washington Editor
NEW ORLEANS - In addition to breakthrough scientific data, organizers of this year's...
Heart failure docs must deal with fast pace of tech change.
May 9, 2005... Heart Rhythm 2005
Heart failure docs must deal with fast pace of tech change
By CHRISTOPHER DELPORTE
Medical Device Daily Washington Editor
NEW ORLEANS - Just in the last few years, the approach to heart failure treatment has...
International report.
May 9, 2005... International report
Tariffs and taxes take a toll on access to drugs, devices
A Medical Device Daily Staff Report
A new working paper published by the American Enterprise Institute-Brookings Joint Center (Washingon) says that...
New CMS '3-pronged' criteria will guide new mobility coding.(Centers for Medicare & Medicaid Services)
May 9, 2005... New CMS '3-pronged' criteria will guide new mobility coding
By DON LONG
Medical Device Daily Managing Editor
In a move obviously intended to diffuse recent and ongoing controversy concerning which Medicare beneficiaries should or...
Financings roundup.
May 9, 2005... Financings roundup
Xoft closes $30 million round; dj amends credit agreement
A Medical Device Daily Staff Report
Xoft (Fremont, California), a company developing electronic brachytherapy for cancer treatment, has closed a...
Company to adopt SRI Surgical name.(SRI/Surgical Express will operate under the name SRI Surgical and will use the promotional tagline "Efficiency, Delivered daily.")(Brief Article)
May 9, 2005... Company to adopt SRI Surgical name
SRI/Surgical Express (Tampa, Florida) reported that it will operate under the name SRI Surgical and will use the promotional tagline "Efficiency, Delivered daily." The company's legal name will not...
Knowledge about devices and makers not always a positive.
May 9, 2005... Commentary
Knowledge about devices and makers not always a positive
By DON LONG
Medical Device Daily Managing Editor
We have long thought that a fairly significant dividing line between the pharmaceutical and device sectors of...
Deals roundup.
May 9, 2005... Deals roundup
ResMed agrees to buy Saime; Theragenics to discuss CP buy
A Medical Device Daily Staff Report
ResMed (San Diego) reported that it has entered into a definitive agreement to acquire Saime (Temple, France), a developer...
Harris Poll: Terri Schiavo case not unusual.(Brief Article)
May 9, 2005... Harris Poll: Terri Schiavo case not unusual
Harris Interactive (Rochester, New York) said the Terri Schiavo case focused public attention on the legal and medical issues related to the use of feeding tubes and life support systems for...
Court report.
May 9, 2005... Court report
Plastic surgery center owner sentenced, faces more charges
A Medical Device Daily Staff Report
Michigan Attorney General Mike Cox reported last week that the former owner of Complete Makeover Center (Troy, Michigan)...
Finalists set for stem-cell institute.(Brief Article)
May 9, 2005... Finalists set for stem-cell institute
The site search subcommittee of the Independent Citizens' Oversight Committee (ICOC; Emeryville, California) announced its final award of points to the four finalist proposals based on visits to each...
Meeting 'MRADLs' a key to reducing medical co.
May 9, 2005... Meeting 'MRADLs' a key to reducing medical costs
In developing new criteria for reimbursement of both power mobility and other mobility equipment, the Centers for Medicare & Medicaid Services (CMS; Baltimore) clearly has accepted the...
People in Places.
May 9, 2005... People in Places
* Richard Malcolm, PhD, has been appointed CEO of Acurian (Horsham, Pennsylvania), replacing Mark Eisenach, who concluded a four-year tenure as CEO. Malcolm most recently was vice president of business development at Icon...
Briefly Noted.
May 9, 2005... Briefly Noted
MEDirect Latino expands operations
MEDirect Latino (Plantation, Florida), a provider of direct-to-consumer, Medicare-reimbursed products focus-ed on chronic diseases afflicting the Hispanic community in the U.S. and...
Product Briefs.
May 9, 2005... Product Briefs
* Possis Medical (Minneapolis) said the FDA has cleared its 6 Fr DVX peripheral catheter to be labeled for breaking apart and removing thrombus from leg arteries greater than or equal to 3 mm in diameter. The DVX catheter...
New mapping, ablation tech offer hope for better AF results.(atrial fibrillation)
May 10, 2005... Heart Rhythm 2005
New mapping, ablation tech offer hope for better AF results
By LARRY HAIMOVITCH
Medical Device Daily Contributing Writer
NEW ORLEANS - Once thought of as an arcane and boring sub-specialty, the field of...
Deals roundup.
May 10, 2005... Deals roundup
Theragenics closes $25.4M cash/stock buy of CP Medical
A Medical Device Daily Staff Report
Theragenics (Buford, Georgia), manufacturer of the TheraSeed palladium-103 cancer treatment device, reported that it has...
Report from Europe.
May 10, 2005... Report from Europe
Robot-assisted, image-guided surgery sectors seen growing
A Medical Device Daily Staff Report
The popularity of minimally invasive surgery is seen as boosting the growth prospects in Europe for enabling...
VB continues its orthopedic focus with Spine Motion launch.
May 10, 2005... VB continues its orthopedic focus with Spine Motion launch
By HOLLAND JOHNSON
Medical Device Daily Associate Managing Editor
Most venture capitalists (VCs) in the healthcare sector are continuously on the hunt for the next big...
Court report.
May 10, 2005... Court report
AMO wins $94.8M in patent case; Alcon to seek set-aside
A Medical Device Daily Staff Report
Advanced Medical Optics (AMO; Santa Ana, California) reported that it has won its case against Alcon Manufacturing and Alcon...
Financings roundup.
May 10, 2005... Financings roundup
InSite to get $9M privately; Immunicon puts $75M on shelf
A Medical Device Daily Staff Report
InSite Vision (Alameda, California), an ophthalmic therapeutics, diagnostics and drug-delivery company, said it has...
Study cites standardized set of ICD detection parameters.(implantable cardioverter-defibrillators)
May 10, 2005... HRS notebook
Study cites standardized set of ICD detection parameters
A Medical Device Daily Staff Report
A late-breaking clinical trials session held on Saturday, the final day of this year's Heart Rhythm 2005 meeting in New...
Grants/contracts.
May 10, 2005... Grants/contracts
HHS awards $95 million to 25 grantees for cancer programs
A Medical Device Daily Staff Report
Grants totaling $95 million will be awarded to up to 25 grantees to develop a new program that will reduce the number of...
Briefly Noted.
May 10, 2005... Briefly Noted
Nasdaq to de-list Cardima
Cardima (Fremont, California), developer of the Revelation Tx, Revelation T-Flex and Revelations Helix microcatheter systems for the treatment of atrial fibrillation (AF), received a Nasdaq staff...
Product Briefs.
May 10, 2005... Product Briefs
* A-Life Medical (San Diego), a provider of advanced natural language processing-(NLP) based solutions - which have the ability to read and understand electronic text just as a human does - has released its pathology coding...
People in Places.
May 10, 2005... People in Places
* Eugene Fife, chairman and director of Eclipsys (Boca Raton, Florida), has been named to the additional roles of president and CEO. Fife has been chairman since January 2003 and a director since 1997. He succeeds Paul...
Gathering puts big spotlight on Upper Midwest device sector.
May 11, 2005... Medtech Investing Conference
Gathering puts big spotlight on Upper Midwest device sector
By JIM STOMMEN
Medical Device Daily Executive Editor
MINNEAPOLIS - Don Gerhardt, president and CEO of Medical Alley/MNBIO (St. Louis...
Tm Bioscience wins first-ever FDA okay for DNA test for CF.
May 11, 2005... Tm Bioscience wins first-ever FDA okay for DNA test for CF
By KAREN YOUNG
Medical Device Daily Staff Writer
Tm Bioscience (Toronto) and the FDA reported late Monday that Tm Bioscience's Tag-It Cystic Fibrosis Kit is the first...
Jarvik Heart receives CE mark for its thumb-sized LVAD.(left-ventricular assist device)
May 11, 2005... Report from Europe
Jarvik Heart receives CE mark for its thumb-sized LVAD
A Medical Device Daily Staff Report
Jarvik Heart (New York) reported that it has received CE mark certification for the Jarvik 2000 FlowMaker, a small...
Resurgent CryoLife reports first Clearant-treated ortho implant.
May 11, 2005... Resurgent CryoLife reports first Clearant-treated ortho implant
By HOLLAND JOHNSON
Medical Device Daily Associate Managing Editor
Tissue processing and bio-surgical device company CryoLife (Kennesaw, Georgia) - embattled but on the...