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New research on prostate cancer.
January 2, 2007... New research on prostate cancer
'Watchful waiting' downgraded clinically, upgraded financially
By MARK McCARTY
Medical Device Daily Washington Editor
The typical layperson finds medical opinion confusing partly because...
Yale study: colon cancer found earlier with Medicare changes.
January 2, 2007... Yale study: colon cancer found earlier with Medicare changes
By KAREN YOUNG
Medical Device Daily Staff Writer
A study of Medicare patients by researchers at the Yale University School of Medicine (New Haven, Connecticut) showed an...
International report.
January 2, 2007... International report
Zoll wins Canadian approval for R Series in-hospital unit
A Medical Device Daily Staff Report
Resuscitation device maker Zoll Medical (Chelmsford, Massachusetts) reported that it has received a Medical Device...
Pediatric brain surgery needs concerted, coordinated effort.
January 2, 2007... Pediatric brain surgery needs concerted, coordinated effort
By CYNTHIA DRAKE
Medical Device Daily Contributing Writer
Pediatric neurosurgeons at the Rainbow Babies & Children's Hospital (Cleveland) presented a live webcast of a...
Financial challenges requires an attack on different fronts.
January 2, 2007... Financings roundup
Follow-on offer for Uroplasty brings total to $4.4 million
A Medical device Daily Staff Report
Uroplasty (Minnetonka, Minnesota), a manufacturer of products for the treatment of voiding dysfunctions, said it has...
Briefly Noted.
January 2, 2007... Briefly Noted
Strategic plan for nanotech workplaces needed
A strategic plan and more resources for risk research are needed in order to ensure safe nano-workplaces today and in the future, according to Andrew Maynard, chief science...
CMS roundup.
January 2, 2007... CMS roundup
Advisory group gets new name and role for assessing evidence
A Medical Device Daily Staff Report
The Center for Medicare and Medicaid Services last week reported that the Medicare Coverage Advisory Committee has been...
FDA adds lot number update to report of counterfeit test strips.(test strips for One Touch Brand Blood Glucose Monitors)
January 2, 2007... FDA adds lot number update to report of counterfeit test strips
A Medical Device Daily Staff Report
The FDA late last week provided an update to its Oct. 13 and Oct. 23 notifications, alerting the public to counterfeit blood glucose...
Deals roundup.(Medical Consultants merges with Advanced Data Processing, which acquires Intermedix)
January 2, 2007... Deals roundup
Medical Consultants buys ADPI and ADPI acquires Intermedix
A Medical Device Daily Staff Report
Medical Consultants (Fort Lauderdale, Florida), a provider of emergency department billing services, and Advanced Data...
Company-sponsored DES trials feature "lower study quality".(drug-eluting stents)
January 3, 2007... Canadian journal report charge:
Company-sponsored DES trials feature 'lower study quality'
By MARK McCARTY
Medical Device Daily Washington Editor
Makers of drug-eluting stents (DES) may think that their products could not...
Breast cancer screening study: no benefit for 40-50 age group.
January 3, 2007... Breast cancer screening study: no benefit for 40-50 age group
By KAREN YOUNG
Medical Device Daily Staff Writer
Toward the end of 2006, women have been presented with one more piece of confusing health news and advice -- as it...
Report from Europe.
January 3, 2007... Report from Europe
Vascular Genomics Network in three new research platforms
A Medical Device Daily Staff Report
The European Vascular Genomics Network (EVGN), a Network of Excellence funded by the European Union within its 6th...
Neuralstem lists on OTCBB, will start clinical trials soon.
January 3, 2007... Neuralstem lists on OTCBB, will start clinical trials soon
By KAREN PIHL-CAREY
Medical Device Daily Staff Writer
As a stem cell company preparing to enter clinical trials in 2007, Neuralstem (Rockville, Maryland) began trading last...
Court report.
January 3, 2007... Court report
FTC challenges alleged price fixing by Chicago physicians
A Medical Device Daily Staff Report
The Federal Trade Commission (FTC) yesterday reported that it is challenging the conduct of several organizations...
Financings roundup.
January 3, 2007... Financings roundup
HLM closes oversubscribed $216 million healthcare fund
By HOLLAND JOHNSON
Medical Device Daily Associate Managing Editor
HLM Venture Partners (Boston), a healthcare venture capital firm that invests in...
Briefly Noted.
January 3, 2007... Briefly Noted
Nasdaq news . . .
* HEI (Minneapolis) reported the listing of its common stock was transferred to The NASDAQ Capital Market at the opening of business Thursday. The trading symbol for the company's common stock, "HEII,"...
Deals roundup.
January 3, 2007... Deals roundup
PerkinElmer acquires Triton line; Eisai licenses Rosetta Elucidator
A Medical Device Daily Staff Report
PerkinElmer (Boston) reported the acquisition of a line of dynamic mechanical analysis (DMA) products from...
Agreements roundup.
January 3, 2007... Agreements roundup
Premier says FFF will continue to distribute its plasma products
A Medical Device Daily Staff Report
Premier Purchasing Partners (Charlotte, North Carolina) reported that FFF Enterprises (Temecula, California)...
<i>MDD</I> releases new report on orthopedics market.
January 3, 2007... MDD releases new report on orthopedics market
The publishers of Medical Device Daily have just released a new 200-page report focusing on the orthopedics sector, Orthopedics 2006 -- Trends, Challenges and Opportunities. The report provides...
People in Places.
January 3, 2007... People in Places
* Carol Berry has been named VP of sales for AviaraDx (Carlsbad, California), a company that does molecular cancer profiling. Berry has been responsible for the North American sales and corporate marketing at Ciphergen...
BioWorld report looks at biotechnology executive pay.
January 3, 2007... BioWorld report looks at biotechnology executive pay
The editors of BioWorld Today, sister publication to Medical Device Daily, have recently completed the new BioWorld Executive Compensation Report, updated for 2007 and providing an...
CBO sets doc fix tab at $3.1B, but SGR cuts resume in '09.(Congressional Budget Office estimates for sustainable growth rate mechanism)
January 4, 2007... CBO sets doc fix tab at $3.1B, but SGR cuts resume in '09
By MARK McCARTY
Medical Device Daily Washington Editor
Congress opted to roll back the proposed reductions to Medicare Part B doctor's fees in December, but the so-called...
AVSH programming supports ICD dual-chamber pacing benefits.(AV Search Hysteresis use with implantable cardioverter defibrillator)
January 4, 2007... AVSH programming supports ICD dual-chamber pacing benefits
By HOLLAND JOHNSON
Medical Device Daily Associate Managing Editor
The results of the largest implantable cardioverter defibrillator (ICD) study to date, known as INTRINSIC...
Report from Europe.(Sartorius buys Toha Plast)(breast cancer gene discovered at Institute of Cancer Research)(Gerresheimer acquires Wilden)
January 4, 2007... Report from Europe
Sartorius buys medical/biotech plastic manufacturer Toha Plast
A Medical Device Daily Staff Report
Sartorius (Goettingen, Germany), a laboratory and process equipment provider, reported acquiring acquired all...
New biomarker offers hope of early diagnosis of Alzheimer's.
January 4, 2007... New biomarker offers hope of early diagnosis of Alzheimer's
A Medical Device Daily Staff Report
You may not be able to teach an old dog new tricks, but doctors could one day have some new imaging tricks for diagnosing Alzheimer's...
Court report.
January 4, 2007... Court report
Quovadx settles last of three legacy lawsuits for $7.8 million
A Medical Device Daily Staff Report
Medical software firm Quovadx (Greenwood Village, Colorado) yesterday reported that it has reached an agreement to...
Briefly Noted.
January 4, 2007... Briefly Noted
MOST renamed iSALUS Healthcare
MOST (Indianapolis) has been renamed iSALUS Healthcare. The company said that the name change supports its commitment to help physicians provide the services that their patients need to...
Deals roundup.
January 4, 2007... Deals roundup
Siemens completes $5.3 billion buy of Bayer Diagnostics unit
A Medical Device Daily Staff Report
The $5.3 billion acquisition of Bayer Diagnostics (Tarrytown, New York) by Siemens Medical Solutions (Malvern,...
Financings roundup.
January 4, 2007... Financings roundup
ProQuest closes $425M fund; Arcadia gathers in $10 million
A Medical Device Daily Staff Report
ProQuest Investments (Princeton, New Jersey), a venture capital firm focused on healthcare, reported the closing of...
New financing avoids shutdown of operations by Sontra Medical.
January 4, 2007... New financing avoids shutdown of operations by Sontra Medical
A Medical Device Daily Staff Report
On the verge of closing down its business, Sontra Medical (Franklin, Massachusetts), a developer of transdermal technology, yesterday...
Agreements roundup.
January 4, 2007... Agreements roundup
PortBlue's PracticeSense to be marketed by Olympus America
A Medical Device Daily Staff Report
PortBlue (Los Angeles), a provider of web-based expert systems, reported an agreement with Olympus (Tokyo), a...
Product Briefs.
January 4, 2007... Product Briefs
* Cadent (Carlstadt, New Jersey) reported future product and service updates in its line of OrthoCAD devices. These products provide 3-D digital solutions for the orthodontic industry. The enhanced services include...
People in Places.
January 4, 2007... People in Places
* Michael Farley has been named interim CEO of the American Diabetes Association (Alexandria, Virginia). Farley, currently the association's chief community and corporate relations officer, succeeds Lynn Nicholas who...
Study concludes Medtronic's Meniett device effective, safe.
January 5, 2007... Study concludes Medtronic's Meniett device effective, safe
By KAREN YOUNG
Medical Device Daily Staff Report
Results of a two-year follow-up study show that about two-thirds of Meniere's disease patients who are unresponsive to...
Studies cast doubt on patient benefits and impact of P4P.
January 5, 2007... Studies cast doubt on patient benefits and impact of P4P
By MARK McCARTY
Medical Device Daily Washington Editor
Fans of pay for performance, or P4P as it is known in the land of acronyms, have probably steeled themselves for some...
Report from Europe.
January 5, 2007... Report from Europe
Cellectis files IPO prospectus on the Paris Stock Exchange
By JAMES ETHERIDGE
Medical Device Daily International Correspondent And MDD Staff Reports
Cellectis (Romainville, France) has filed a preliminary...
Financings roundup.
January 5, 2007... Financings roundup
Stentys gathers 'seed' round for bifurcation stent development
By HOLLAND JOHNSON
Medical Device Daily Associate Managing Editor
A company developing a new approach to the treatment of lesions in bifurcated...
Court report.
January 5, 2007... Court report
Ruling reaffirms $7M payment to Innogenetics by Abbott Labs
A Medical Device Daily Staff Report
Innogenetics (Gent, Belgium) reported that a U.S. District Court judge for the Western District of Wisconsin affirmed a...
Briefly Noted.
January 5, 2007... Briefly Noted
Expanded Down Syndrome screening sought
All pregnant women, regardless of their age, should be offered screening for Down Syndrome, according to a new Practice Bulletin issued by The American College of Obstetricians and...
Deals roundup.
January 5, 2007... Deals roundup
Boston Sci closes EndoTex buy; LSO acquires parent company
A Medical Device Daily Staff Report
Boston Scientific (Natick, Massachusetts) reported that it has completed the purchase of EndoTex Interventional Systems...
Agreements roundup.
January 5, 2007... Agreements roundup
Schering-Plough and OraSure in pact to develop, sell HCV test
A Medical Device Daily Staff Report
Schering-Plough (Kenilworth, New Jersey) and OraSure Technologies (Bethlehem, Pennsylvania) reported a...
Product Briefs.
January 5, 2007... Product Briefs
• Charles River Laboratories International (Wilmington, Massachusetts) reported its portable endotoxin testing system, the Endosafe- PTS, was recently launched into space aboard the space shuttle Discovery and reached...
MedicalCV says it will amend Solar System 510(k) application.(Brief article)
January 5, 2007... MedicalCV says it will amend Solar System 510(k) application
A Medical Device Daily Staff Report
Cardiovascular surgery company MedicalCV (Inver Grove Heights, Minnesota) said it is determined to amend its 510(k) submission for...
People in Places.
January 5, 2007... People in Places
• William Albright Jr. has been named CFO for ForteBio (Menlo Park, California). Albright most recently was CFO and senior VP, finance and operations of Xenogen, acquired by Caliper Life Sciences last year. ForteBio...
Despite slowing, sentiment for healthcare sector is positive.
January 8, 2007... JP Morgan Healthcare Conference
Despite slowing, sentiment for healthcare sector is positive
By HOLLAND JOHNSON
Medical Device Daily Associate Managing Editor
As the JP Morgan Healthcare Conference begins today -- marking, in...
Briefly Noted.
January 8, 2007... Briefly Noted
ON-Q Medicare-covered for post-surgery pain
I-Flow (Lake Forest, California) said that effective Jan. 1, Medicare covers ON-Q to treat post-surgical pain under the hospital outpatient payment system (OPPS). The decision...
ELAD liver-assist device shows good interim results in China.(Extracorporeal Liver Assist Device)
January 8, 2007... ELAD liver-assist device shows good interim results in China
By KAREN YOUNG
Medical Device Daily Staff Writer
Vital Therapies (VTI; San Diego), a company attempting to bring to market what would be the first "bioartificial"...
Report from Europe.
January 8, 2007... Report from Europe
Cinvention, Relisys extend deal for 'non-eluting' matrix stent
A Medical Device Daily Staff Report
Cinvention (Wiesbaden, Germany) reported extension of a license and supply agreement with Relisys Medical...
Thermal meter gives diabetics chance to stave off foot ulcers.(TempTouch home infrared thermal probe from Xilas Medical)
January 8, 2007... Thermal meter gives diabetics chance to stave off foot ulcers
By MARK McCARTY
Medical Device Daily Washington Editor
Diabetic ulcers can wreak havoc on the life of the patient, and also on the patient's friends and family....
Court report.
January 8, 2007... Court report
evYsio reports stent patent win in French court vs. Abbott firms
A Medical Device Daily Staff Report
evYsio Medical Devices (Vancouver, British Columbia) reported that a French court has ruled in its favor in a patent...
Deals roundup.
January 8, 2007... Deals roundup
Consorta, HealthTrust merger to create one of largest GPOs
A Medical Device Daily Staff Report
Group purchasing organizations Consorta (Schaumburg, Illinois) and HealthTrust Purchasing Group (Brentwood, Tennessee)...
Dade Behring to shut Cupertino reagent plant and cut 130 jobs.
January 8, 2007... Dade Behring to shut Cupertino reagent plant and cut 130 jobs
A Medical Device Daily Staff Report
Dade Behring (Deerfield, Illinois) last week said that it is closing its Cupertino, California reagent product operations to streamline...
Current Tech wins extension of promissory note to January '08.(Current Technology)(Brief article)
January 8, 2007... Current Tech wins extension of promissory note to January '08
A Medical Device Daily Staff Report
Current Technology (Vancouver) said that it has reached a verbal agreement in principle with the company's largest shareholder, Keith...
AMO says FDA questions will delay launch of Tecnis IOL.
January 8, 2007... AMO says FDA questions will delay launch of Tecnis IOL
A Medical Device Daily Staff Report
Eye care firm Advanced Medical Optics (AMO; Santa Ana, California) last week reported that the FDA has recommended that the company enroll...
Product Briefs.
January 8, 2007... Product Briefs
* CorCell (Philadelphia) a business of Cord Blood America (Los Angeles) company, said that cord blood collected and stored by one of its private, family customers was used in what is believed to be the first autologous cord...
People in Places.
January 8, 2007... People in Places
* Pierre Maison-Blanche, MD, has been named chief medical officer for Biomedical Systems (St. Louis/Brussels, Belgium). In addition to his duties as Biomedical Systems' Chief Medical Officer, Maison-Blanche serves as a...
Braunstein: Both conference and sector have come far in 25 years.(Douglas Braunstein on Morgan Healthcare Conference)
January 9, 2007... JP Morgan Healthcare Conference
Braunstein: Both conference and sector have come far in 25 years
By HOLLAND JOHNSON
Medical Device Daily Staff Report
SAN FRANCISCO -- As the JP Morgan Healthcare Conference kicked off its 25th...
AMO, Intralase merger seen as complementary in $808M deal.(Advanced Medical Optics)
January 9, 2007... AMO, Intralase merger seen as complementary in $808M deal
By MARK McCARTY
Medical Device Daily Washington Editor
The laser vision correction (LVC) market has been the source of rumblings for some time, due in part to the fact that...
Briefly Noted.
January 9, 2007... Briefly Noted
Stem cell market set to double
Sales of stem cell products in the U.S. reached $16.4 million last year and are expected to surpass $35 million in 2007, according to Robin Young, a medical industry analyst. The products,...
Report from Europe.
January 9, 2007... Report from Europe
Spirus Medical gets CE mark for two Endo-Ease products
A Medical Device Daily Staff Report
Spirus Medical (Stoughton, Massachusetts) reported receiving the CE mark for its Endo-Ease Advantage and Endo-Ease Vista...
'D' $42.2M will back Calypso's launch of localization system.
January 9, 2007... 'D' $42.2M will back Calypso's launch of localization system
By DON LONG
Medical Device Daily Managing Editor
Calypso Medical Technologies (Seattle) reported closure of its Series D private equity financing, totaling $42.2...
Agreements.
January 9, 2007... Agreements
Illumina, Canadian hospital enter pact for newborn molecular tests
By KAREN YOUNG
Medical Device Daily Staff Writer
Illumina (San Diego) and the Children's Hospital of Eastern Ontario (CHEO; Ottawa) have entered a...
Financing roundup.
January 9, 2007... Financing roundup
Fluidigm gathers in $37 million to support marketing of Topaz
A Medical Device Daily Staff Report
Fluidigm (South San Francisco), a leader in integrated fluidic circuits (IFCs) for life science, has raised $37...
Caliper creates new <I>in vitro</I> to<I> in vivo</I> drug services company.
January 9, 2007... Caliper creates new in vitro to in vivo drug services company
A Medical Device Daily Staff Report
Caliper Life Sciences (Hopkinton, Massachusetts) yesterday unveiled Caliper Discovery Alliances & Services (CDAS), newly-formed from the...
Deals roundup.
January 9, 2007... Deals roundup
USPI in merger agreement with UNCN Acquisition for $1.8B
A Medical Device Daily Staff Report
United Surgical Partners International (USPI; Addison, Texas) reported signing an agreement to merge with UNCN Acquisition,...
Product Briefs.
January 9, 2007... Product Briefs
* Applied Digital Solutions (Delray Beach, Florida) though its subsidiary VeriChip, reported that the U.S. Patent and Trademark Office granted VeriChip a patent for its portable RFID asset location system. The patent, No. #...
People in Places.
January 9, 2007... People in Places
* Maureen Mende has been appointed director of regulatory affairs and quality assurance for Diamics (Novato, California). Most recently Mende served as regulatory affairs group manager for Dade Behring. Diamics is a...
diaDexus, Hologic forging larger profits via diagnostic products.
January 10, 2007... JP Morgan Healthcare Conference
diaDexus, Hologic forging larger profits via diagnostic products
By HOLLAND JOHNSON
Medical Device Daily Associate Managing Editor
SAN FRANCISCO -- As is usually the case here at the JP Morgan...
Boston Scientific to cut 500-600 from CRM unit, formerly Guidant.
January 10, 2007... Boston Scientific to cut 500-600 from CRM unit, formerly Guidant
By DON LONG
Medical Device Daily Managing Editor
It took a while for Boston Scientific (Natick, Massachusetts) to go to the chopping block following its purchase of...
Report from Europe.
January 10, 2007... Report from Europe
Abiomed wins CE marking for iPulse console platform, IAB
A Medical Device Daily Staff Report
Abiomed (Danvers, Massachusetts) reported receiving the CE mark for its intra-aortic balloon (IAB) and iPulse console...
Signalife to seek clearance of ambulatory ECG cardiac vest.
January 10, 2007... Signalife to seek clearance of ambulatory ECG cardiac vest
By KAREN YOUNG
Medical Device Daily Staff Writer
In the future, ECG monitoring may be available to those heart patients requiring continuous monitoring in the form of a...
Court report.
January 10, 2007... Court report
Intuitive says lawsuit by Caltech meritless, files counter action
A Medical Device Daily Staff Report
Intuitive Surgical (Sunnyvale, California), a leader in surgical robotics, issued a statement regarding a patent...
Grants/contracts.
January 10, 2007... Grants/contracts
FDA licenses GastroPlus software for government-based research
By AMANDA PEDERSEN
Medical Device Daily Staff Writer
A computer program designed to simulate the way drugs are absorbed in the gastrointestinal...
NovaVision in $20M in Series C funding to back VRT marketing.
January 10, 2007... NovaVision in $20M in Series C funding to back VRT marketing
By AMANDA PEDERSEN
Medical Device Daily Staff Writer
NovaVision (Boca Raton, Florida) reported that it has secured $20 million in Series C funding. NovaVision said the...
Deals roundup.
January 10, 2007... Deals roundup
Conor reports waiting period concluded for buy by J&J
A Medical Device Daily Staff Report
Conor Medsystems (Menlo Park, California) reported that the U.S. Federal Trade Commission has granted early termination of the...
Product Briefs.
January 10, 2007... Product Briefs
* Affymetrix (Santa Clara, California) said it has made its new single-chip SNP 5.0 Array available as a limited release. The new array features single nucleotide polymorphisms (SNPs) from the original two-chip 500K Array...
People in Places.
January 10, 2007... People in Places
* Mintz, Levin, Cohn, Ferris, Glovsky and Popeo (New York) -- a 480-lawyer AmLaw 100 firm with offices throughout the U.S. and the UK -- has expanded its New York Health Law Practice with the addition of three attorneys....
Brailer: Industry will lead change where government fails to act.(David Brailer, president of American Health Information Community)
January 11, 2007... JP Morgan Healthcare Conference
Brailer: Industry will lead change where government fails to act
By HOLLAND JOHNSON
Medical Device Daily Associate Managing Editor
SAN FRANCISCO -- "I personally don't look for the federal...
Onex buys Kodak's Health Group in deal worth up to $2.55 billion.(Company overview)
January 11, 2007... Onex buys Kodak's Health Group in deal worth up to $2.55 billion
By AMANDA PEDERSEN
Medical Device Daily Staff Writer
Eastman Kodak (Rochester, New York) will be able to sharpen its focus on consumer and professional imaging and...
International report.
January 11, 2007... International report
Canada okays sale of Melody pulmonary valve by Medtronic
A Medical Device Daily Staff Report
Medtronic (Minneapolis) reported receiving a Medical Device License from Health Canada to sell its Melody...
Neurostimulator by BioControl targets heart rather than brain.
January 11, 2007... Neurostimulator by BioControl targets heart rather than brain
By KAREN YOUNG
Medical Device Daily Staff Writer
Electro-cardiac devices are normally implanted in the chest, electro-neurological devices usually in the neck or in or...
Licenses likely to be impacted by Supreme Court patent ruling.(MedImmune patent litigation against Genentech)
January 11, 2007... Licenses likely to be impacted by Supreme Court patent ruling
By AARON LORENZO
Medical Device Daily Staff Writer
WASHINGTON -- The U.S. Supreme Court has sided overwhelmingly in favor of the appeal by MedImmune (Gaithersburg,...
Agreements.
January 11, 2007... Agreements
CryoLife, Cleveland Clinic form accord to develop heart valve
A Medical Device Daily Staff Report
CryoLife (Kennesaw, Georgia), a biomaterials and tissue processing company, has entered an agreement with the Cleveland...
Deals roundup.
January 11, 2007... Deals roundup
Langer closes its $1.64M buy of Regal Medical Supply
A Medical Device Daily Staff Report
Langer (Deer Park, New York) reported the closing of the acquisition of substantially all the assets of Regal Medical Supply...