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Tobin issues tough critique as basic to Guidant turn-around.
December 1, 2006... Piper Jaffray Healthcare Conference
Tobin issues tough critique as basic to Guidant turn-around
By DON LONG
Medical Device Daily Managing Editor
NEW YORK -- Forget the cornucopia of Power Points. Don't detail recent or future...
MedQuist to make SpeechQ voice recognition mainstream.
December 1, 2006... Radiological Society of North America
MedQuist to make SpeechQ voice recognition mainstream
By KAREN YOUNG
Medical Device Daily Staff Writer
CHICAGO -- Earlier this year, MedQuist (Mount Laurel, New Jersey), reported that it...
Report from Europe.
December 1, 2006... Report from Europe
Durect, Nycomed agree on Posidur pain relief effort
A Medical Device Daily Staff Report
Durect (Cupertino, California) reported the signing of a collaboration agreement with Nycomed (Roskilde, Denmark), a...
Washington roundup.
December 1, 2006... Washington roundup
Scientist says master cardiac stem cells no threat to devices
By MARK McCARTY
Medical Device Daily Washington Editor
Stem cells are back in the news with the announcement yesterday that a team at the...
Deals roundup.
December 1, 2006... Deals roundup
Cardinal to sell PTS segment to focus on provider market
By AMANDA PEDERSEN
Medical Device Daily Staff Writer
Cardinal Health (Dublin, Ohio) said it plans to sell its Pharmaceutical Technologies and Services...
Financings roundup.
December 1, 2006... Financings roundup
MedCath adds to offers with sale of over-allotments
A Medical Device Daily Staff Report
MedCath (Charlotte, North Carolina) reported that the underwriters of its common stock offering exercised their...
Grants/contracts.
December 1, 2006... Grants/contracts
Spire gets catheter grant; Premier in accord with J&J unit
A Medical Device Daily Staff Report
Spire (Bedford, Massachusetts) said it has received a Small Business Innovation Research Phase I grant for $176,244...
Court report.
December 1, 2006... Court report
Enzo reports ruling rejecting immediate interlocutory appeal
A Medical Device Daily Staff Report
Enzo Biochem (New York) reported that the U.S. Court of Appeals for the Federal Circuit (CAFC) has denied permission for...
Briefly Noted.
December 1, 2006... Briefly Noted
Gender-specific knees a trend in implant market
Millennium Research Group (MRG; Waltham, Massachusetts) said it has conducted a detailed analysis of the U.S. large-joint implant market. The analysis finds that one of the...
Product Briefs.
December 1, 2006... Product Briefs
* AngioDynamics (Queensbury, New York) has received 510(k) clearance for Oncobionic to market irreversible electroporation (IRE) -- a technology indicated for surgical ablation of soft tissue, including cardiac and smooth...
People in Places.
December 1, 2006... People in Places
* Talyst (Bellevue, Washington) has named Ron Strandin president of its Acute Care Group, which will continue the company's advancement of pharmacy technology for hospitals. He has been serving as executive vice president...
SilverHawk to NightHawk is next big step for FoxHollow.
December 4, 2006... Piper Jaffray Healthcare Conference
SilverHawk to NightHawk is next big step for FoxHollow
By DON LONG
Medical Device Daily Managing Editor
NEW YORK -- John Simpson, MD, PhD, said his staff wouldn't let him talk about the...
Guardian studying bomb-threat technology in healthcare arena.
December 4, 2006... Radiological Society of North America
Guardian studying bomb-threat technology in healthcare arena
By KAREN YOUNG
Medical Device Daily Staff Report
CHICAGO -- What do bomb detection technology and healthcare imaging technology...
Report from Europe.(standardization)
December 4, 2006... Report from Europe
Interventional Spine receives CE mark for its PDS System
A Medical Device Daily Staff Report
Interventional Spine (formerly Triage Medical; Irvine, California) reported that its European notified body has granted...
Study finds DES patients more at risk for blood clot formation.
December 4, 2006... Study finds DES patients more at risk for blood clot formation
By AMANDA PEDERSEN
Medical Device Daily Staff Writer
In just a few days a panel of federal health officials and outside experts will meet in Washington to scrutinize...
Financings roundup.
December 4, 2006... Financings roundup
Dade Behring in stock buyback; Angiotech prices note offering
A Medical Device Daily Staff Report
Clinical diagnostics company Dade Behring Holdings (Deerfield, Illinois) reported that its board of directors has...
Deals roundup.
December 4, 2006... Deals roundup
AMS sells Laserscope aesthetic assets to Iridex for $37 million
A Medical Device Daily Staff Report
American Medical Systems Holdings (AMS; Minnetonka, Minnesota) reported that it signed a definitive agreement to sell...
Agreements.(Dmetrix Inc.)(Smiths Medical Inc.)(Inditherm Ltd)
December 4, 2006... Agreements
Emageon in Allscripts pact for TouchWorks software
A Medical Device Daily Staff Report
Emageon (Birmingham, Alabama) reported that it will resell TouchWorks Electronic Health Record (EHR) and Practice Management (PM)...
Court report.
December 4, 2006... Court report
Lifestream files petition for protection under bankruptcy
A Medical Device Daily Staff Report
Lifestream Technologies (Post Falls, Idaho), a supplier of cholesterol monitors, said yesterday it has filed a petition for...
Briefly Noted.(American Tissue Services Foundation, certified)(Brief article)
December 4, 2006... Briefly Noted
ATSF gets AATB accreditation
American Tissue Services Foundation (ATSF; Oklahoma City) has been awarded accreditation of the American Association of Tissue Banks (AATB, McLean, Virginia).
Accreditation follows an...
Product Briefs.
December 4, 2006... Product Briefs
* ATS Medical (Minneapolis) said it received a notice of allowance from the U.S. Patent and Trademark Office for a key patent application on its anti-coagulation and demineralization of conductive medical devices technology....
People in Places.(appointments)(Accuitive Medical Ventures)(The Innovation Factory)(Brief article)
December 4, 2006... People in Places
* Accuitive Medical Ventures (AMV) and The Innovation Factory (TIF; both Duluth, Georgia) have added Rudy Mazzocchi to both management teams. He will serve as a venture partner with AMV and as vice president, business...
Medtronic seeks growth in mid-teens, will spin AED unit.
December 5, 2006... Medtronic seeks growth in mid-teens, will spin AED unit
By MARK McCARTY
Medical Device Daily Washington Editor
The board of Medtronic (Minneapolis) yesterday afternoon unveiled a plan to send its 1998 acquisition, Physio-Control...
Edwards sells angiogenesis program to Sangamo for $7.5M.
December 5, 2006... Edwards sells angiogenesis program to Sangamo for $7.5M
By HOLLAND JOHNSON
Medical Device Daily Associate Managing Editor
Edwards Lifesciences (Irvine, California) and Sangamo BioSciences (Richmond, California) jointly reported...
Kyphon builds spine arsenal with $525M St. Francis Med buy.(Lusora Healthcare Systems)(acquisitions)
December 5, 2006... Kyphon builds spine arsenal with $525M St. Francis Med buy
By HOLLAND JOHNSON
Medical Device Daily Associate Managing Editor
In a bid to dramatically expand its already potent minimally invasive spine product arsenal, Kyphon...
International report.
December 5, 2006... International report
Misonix signs agreement for device distribution in China
A Medical Device Daily Staff Report
Misonix (Farmingdale, New York), a developer of ultrasonic device technology for the treatment of cancer and other...
Financings roundup.
December 5, 2006... Financings roundup
Vital Images over-allotment sale pushes offering to $98 million
A Medical Device Daily Staff Report
Vital Images (Minneapolis) reported that the underwriters of its recently completed public offering have...
Agreements roundup.
December 5, 2006... Agreements roundup
VisEn, Lilly teaming up in R&D; VQ Ortho to sell Game Ready
A Medical Device Daily Staff Report
VisEn Medical (Woburn, Massachusetts) said it has entered into a joint research program to expand the capabilities...
Grants/contracts.
December 5, 2006... Grants/contracts
Sunrise gains $40M in buyout fees; Clearant and TBI in pact
A Medical Device Daily Staff Report
Sunrise Senior Living (McLean, Virginia) said it has received $40 million in buyout and transition fees from Five Star...
AlloSource and CTS form Joint Restoration Foundation.
December 5, 2006... AlloSource and CTS form Joint Restoration Foundation
A Medical Device Daily Staff Report
AlloSource (Centennial, Colorado) and Community Tissue Services (CTS; Dayton, Ohio) reported that they have formed the Joint Restoration...
Product Briefs.
December 5, 2006... Product Briefs
* MIV Therapeutics (MIVT; Atlanta) said a comparative animal study of two of its novel polymer-free drug-eluting stent coating technologies has concluded with positive results. The study compared stents coated with MIVT's...
People in Places.(appointments)(Brief article)
December 5, 2006... People in Places
* Timothy Healey has been named senior VP of commercial operations for Advanced Magnetics (Cambridge, Massachusetts). Healy previously was executive director, CNS marketing at Sepracor. Advanced Magnetics is a developer...
CMS Roundup.
December 6, 2006... CMS Roundup
Medicare Advantage payments become part of flap over Part B
By MARK McCARTY
Medical Device Daily Washington Editor
A subtext to the ongoing inside-the-Beltway debate concerning the proposed Medicare Part B doctor's...
'Closing loop' for 'holy grail' of diabetes is more than devices.
December 6, 2006... Piper Jaffray Healthcare Conference
'Closing loop' for 'holy grail' of diabetes is more than devices
By DON LONG
Medical Device Daily Managing Editor
Short of a cure for diabetes, the "Holy Grail" to treat this disease is...
Report from Europe.
December 6, 2006... Report from Europe
CMI spin-out OrthoMimetics in series A $9.6 million funding
A Medical Device Daily Staff Report
OrthoMimetics (OM; Cambridge, UK), the first technology spin-out from the Cambridge-MIT Institute (CMI), reported...
AutoCool refrigerates, controls storage of high-value drugs.
December 6, 2006... AutoCool refrigerates, controls storage of high-value drugs
By AMANDA PEDERSEN
Medical Device Daily Staff Writer
Jewelers wouldn't keep their most valuable gems in an unlocked case so why should pharmacies store their most valuable...
Financings roundup.
December 6, 2006... Financings roundup
IPG files for $82 million IPO; Neoprobe in $6M stock accord
A Medical Device Daily Staff Report
IPG Photonics (Oxford, Massachusetts) reported that it has filed for a proposed initial public offering that it...
Edwards discontinues Optiwave and will eliminate 70 positions.
December 6, 2006... Edwards discontinues Optiwave and will eliminate 70 positions
A Medical Device Daily Staff Report
Edwards Lifesciences (Irvine, California) yesterday reported two initiatives: the discontinuation of its Optiwave 980 Cardiac Laser...
Agreements roundup.
December 6, 2006... Agreements roundup
Beaumont tech center helping FDA in patient safety program
A Medical Device Daily Staff Report
The Beaumont Technology Usability Center (Royal Oak, Michigan) said it is assisting the FDA in a national patient...
Deals roundup.(briefs)
December 6, 2006... Deals roundup
ATS buys EM Vascular assets; Biomoda in cancer tech license
A Medical Device Daily Staff Report
ATS Medical (Minneapolis) said it has acquired certain assets of EM Vascular (Shoreview, Minnesota).
It said the...
Briefly Noted.(use of 4D imaging systems)(Brief article)
December 6, 2006... Briefly Noted
4-D imaging key to OB/GYN growth
Millennium Research Group (MRG; Waltham, Massachusetts) has conducted an analysis of the $2.6 billion global ultrasound market and reported that the largest contributor to growth in the...
Product Briefs.(eGene Inc.)(Brief article)
December 6, 2006... Product Briefs
* Cambridge Heart (Bedford, Massachusetts) reported the publication of a study in the Journal of the American College of Cardiology assessing the utility of Microvolt T-Wave Alternans (MTWA) in predicting risk of sudden...
People in Places.(appointments)(Brief article)
December 6, 2006... People in Places
* Donald Margouleff has joined the staff at Daxor (New York) as the director of nuclear medicine. Margouleff is board certified in both Nuclear Medicine and Internal Medicine, is a professor of clinical medicine at the...
Cardinal introduces bar-coded unit-dose packaging service.
December 6, 2006... Cardinal introduces bar-coded unit-dose packaging service
A Medical Device Daily Staff Report
Cardinal Health (Dublin, Ohio) this week unveiled a new service, named ReadyScan, that it targets for improving patient safety by providing...
Schultz mum on whether FDA to seek larger beefed-up trials.
December 7, 2006... Two-day meeting to mull DES
Schultz mum on whether FDA to seek larger beefed-up trials
By MARK McCARTY
Medical Device Daily Washington Editor
WASHINGTON -- The meeting of the FDA's circulatory systems device panel today and...
Presenters for orthopedics - No. 1 to not-quite-so-exciting.
December 7, 2006... Piper Jaffray Healthcare Conference
Presenters for orthopedics -- No. 1 to not-quite-so-exciting
By DON LONG
Medical Device Daily Managing Editor
NEW YORK -- Healthcare conferences are very much like beauty pageants....
Financings roundup.
December 7, 2006... Financings roundup
Underwriters of Hansen IPO take option for $80 million net
A Medical Device Daily Staff Report
Hansen Medical (Mountain View, California) reported that the underwriters of its initial public offering of 6.25...
Genetic study moves closer to basis for addiction to nicotine.
December 7, 2006... NIH roundup
Genetic study moves closer to basis for addiction to nicotine
A Medical Device Daily Staff Report
Results of a new genetic study bring scientists one step closer to understanding why some smokers become addicted to...
Deals roundup.(Diversified Clinical Services and Wound Care Centers unite to form WCS Clinics)(real estate investments of Medical Properties Trust)
December 7, 2006... Deals roundup
DCS and Wound Care Centers to unite under WCS banner
A Medical Device Daily Staff Report
Diversified Clinical Services (DCS; Jacksonville, Florida) and Wound Care Centers (formerly Curative; also Jacksonville)...
Agreements roundup.(Beaumont Technology Usability Center)(Reflect Scientific Inc.)(Vander-Bend Manufacturing)
December 7, 2006... Agreements roundup
iCAD enters pact with Viatronix in virtual colonoscopy
A Medical Device Daily Staff Report
iCAD (Nashua, New Hampshire), a provider of computer-aided detection (CAD) solutions for the early identification of...
Grants/contracts.
December 7, 2006... Grants/contracts
CDC awards $11.4 million to 4 firms to develop H5N1 tests
A Medical Device Daily Staff Report
The Centers for Disease Control and Prevention (Atlanta) reported that it has made $11.4 million in new contracts to...
Briefly Noted.(introducing new health care software)(stock prices of Biomoda)
December 7, 2006... Briefly Noted
ABO to include digital models in certification
Cadent (Carlstadt, New Jersey) reported that the American Board of Orthodontists will incorporate digital study models, including Cadent's OrthoCAD, in its clinical...
Product Briefs.(biomarkers for detection of bladder cancer by CytoCore)(development of health care industry)(Food and Drug Administration approvals for Doppler systems)
December 7, 2006... Product Briefs
* CytoCore (Chicago) reported "highly accurate results" in using its P2X7 biomarker to detect bladder cancer, suggesting broader implications for use in the early detection of cancer in all epithelial cells, the company...
People in Places.(Pittsburgh Life Sciences Greenhouse)(Refac Optical)(Brief article)
December 7, 2006... People in Places
* John Manzetti has been named president/CEO of the Pittsburgh Life Sciences Greenhouse (Pittsburgh). Manzetti joined the PLSG as an executive-in-residence in July and was named chief operating officer in September....
Report from Europe.(4B Med'Concept )
December 7, 2006... Report from Europe
PerkinElmer to pay $29.3 million to acquire Evotec Technologies
By CORMAC SHERIDAN
Medical Device Daily Correspondent
And MDD Staff Reports
Evotec (Hamburg, Germany) is adding about $29.3 million...
Disability in elderly tailing off as Baby Boomers encroach.
December 8, 2006... Disability in elderly tailing off as Baby Boomers encroach
By MARK McCARTY
Medical Device Daily Washington Editor
As administrators at the Centers for Medicare & Medicaid Services work to rein in spending, various stakeholders...
Senate expected to approve von Eschenbach as FDA head.
December 8, 2006... Senate expected to approve von Eschenbach as FDA head
By AARON LORENZO
Medical Device Daily Staff Writer
WASHINGTON – There is a high likelihood that the Senate will confirm Andrew von Eschenbach's nomination as FDA...
Financings roundup.
December 8, 2006... Financings roundup
HydroCision adds $12.7 million private 'G' round to its coffers
By HOLLAND JOHNSON
Medical Device Daily Associate Managing Editor
When a company says it has just completed its 'G' round of financing as...
Deals roundup.(contracts)(acquisitions)
December 8, 2006... Deals roundup
Orthovita enters royalty sale pact with Angiotech Pharma
A Medical Device Daily Staff Report
Orthovita (Malvern, Pennsylvania), a spine and orthopedic biosurgery company, reported that it has entered into a royalty...
Agreements roundup.
December 8, 2006... Agreements roundup
Volcano agrees to provide IVUS catheters free to three entities
A Medical Device Daily Staff Report
Volcano (Rancho Cordova, California), Stanford University (Palo Alto, California), Cardialysis (Rotterdam, the...
Court report.
December 8, 2006... Court report
Texas lawsuits filed against Ortho Evra birth control maker
A Medical Device Daily Staff Report
Three North Texas women have filed lawsuits against the makers of the Ortho Evra birth control patch after doctors...
Grants/contracts.
December 8, 2006... Grants/contracts
Perot Systems selected as one of eight IT providers to VA
A Medical Device Daily Staff Report
Perot Systems (Plano, Texas), a worldwide provider of information technology services and business solutions, reported...
Briefly Noted.
December 8, 2006... Briefly Noted
IsoRay hires Catalyst for investor campaign
IsoRay Medical (Richland, Washington) has selected Catalyst Financial Resources to execute a comprehensive investor awareness campaign aimed at enhancing shareholder value....
Product Briefs.
December 8, 2006... Product Briefs
• Dnikon Instruments (Melville, New York) has introduced the BioStation CT, a fully integrated, self contained cell culture observation device and monitoring system designed to allow users with minimal microscopy...
People in Places.
December 8, 2006... People in Places
• Grant Life Sciences (Los Angeles) has hired Kim Liao as director of Asian business development effective immediately. Between 1995 and 2006, Liao held a variety of executive positions with Abbott Laboratories...
Medtronic's Collins appointed to innovation panel.(appointment of Art Collins at Medtronic)
December 8, 2006... Medtronic's Collins appointed to innovation panel
Commerce Secretary Carlos Gutierrez has named Art Collins, chairman and CEO of Medtronic (Minneapolis), to serve on a new panel to understand better how U.S. innovation contributes to...
Report from Europe.
December 8, 2006... Report from Europe
French insurer will pay for HPV testing of women 30-65
A Medical Device Daily Staff Report
Digene (Gaithersburg, Maryland) said that as of Jan. 1, French insurer MAAF Sante will pay for HPV DNA testing of all...
MannKind offers 20M shares, $100 million in debt to public.
December 8, 2006... MannKind offers 20M shares, $100 million in debt to public
A Medical Device Daily Staff Report
MannKind (Valencia, California) reported that it has agreed to sell an aggregate of 20 million shares of its common stock in an underwritten...
Panel says data not enough to argue DES riskier than BMS.(drug-eluting stents)
December 11, 2006... Panel says data not enough to argue DES riskier than BMS
By MARK McCARTY
Medical Device Daily Washington Editor
GAITHERSBURG, Maryland -- The first day of the FDA's circulatory devices panel seemed replete with the academic and...
Lame duck Senate confirms von Eschenbach to top FDA post.
December 11, 2006... Lame duck Senate confirms von Eschenbach to top FDA post
By HOLLAND JOHNSON
Medical Device Daily Associate Managing Editor
Waiting until the waning hours of a lame duck session of Congress, the Senate finally confirmed Andrew von...
International report.(agreement for development of practice guidelines and reeducating the physicians)(new imaging technology introduced in china)
December 11, 2006... International report
Johns Hopkins part of cardiac education program in Egypt
A Medical Device Daily Staff Report
Johns Hopkins Medicine International (Baltimore) and Sanofi-Aventis Egypt have signed an agreement for educational...
Mayo Clinic team develops breath-hold control device.
December 11, 2006... Mayo Clinic team develops breath-hold control device
By KAREN YOUNG
Medical Device Daily Staff Writer
The very act of breathing, or what is termed "respiratory motion," can throw off radiologists and physicians alike during CT...
Financings roundup.
December 11, 2006... Financings roundup
Advanced Magnetics offering 2.1M shares at $62 per share
A Medical Device Daily Staff Report
Advanced Magnetics (Cambridge, Massachusetts) reported the pricing of an underwritten public offering of 2.1 million...
Grants/contracts.
December 11, 2006... Grants/contracts
NIH funds study by William Beaumont of tumor movement
A Medical Device Daily Staff Report
Lung tumors have been difficult to treat with radiation therapy because patient breathing causes tumors to move around. This...
Deals roundup.(HAPC acquires Infusystem)(Brief article)
December 11, 2006... Deals roundup
HAPC files preliminary proxy related to InfuSystem buy
A Medical Device Daily Staff Report
HAPC (New York) said it has filed a preliminary proxy statement with the Securities and Exchange Commission in connection with...
Court report.(Brief article)(Case overview)
December 11, 2006... Court report
QMed, Alere reach agreement; results in payment to QMed
A Medical Device Daily Staff Report
QMed (Eatontown, New Jersey) reported that it has reached agreement with Alere Medical (Reno, Nevada) to settle the...
Briefly Noted.(AHPC Holdings failed compliance with Nasdaq)(Veridigm Inc changes its name to eNotes Systems)(Brief article)
December 11, 2006... Briefly Noted
AHPC falls out of Nasdaq compliance
AHPC Holdings (Glendale Heights, Illinois) said it has received a Nasdaq Staff Deficiency letter indicating that the company is not in compliance with requirements for continued listing...
Differing thrombosis definitions provided at FDA's panel on DES.
December 11, 2006... Differing thrombosis definitions provided at FDA's panel on DES
What's in a word?
Parsing the meaning of language is a challenge even for the politically inclined, but attaching meaning to the word "thrombosis" during the FDA meeting...
Product Briefs.
December 11, 2006... Product Briefs
* Gel-Del Technologies (St. Paul, Minnesota) said it has received FDA approval for clinical trials of CosmetaLife, a dermal filler injection that the company says holds potential to be a more effective treatment for deep...
People in Places.(appointment of David Dresner at Micell Technologies)(Brief article)
December 11, 2006... People in Places
* Micell Technologies (Raleigh, North Carolina) has appointed David Dresner to serve as its Chief Financial Officer on an interim basis effective Dec. 16. He replaces Jon Kennedy, who is leaving Micell to assume financial...
Off-label use of DES doesn't alter panel recommendations.(drug-eluting stents)
December 12, 2006... Off-label use of DES doesn't alter panel recommendations
By MARK McCARTY
Medical Device Daily Washington Editor
GAITHERSBURG, Maryland -- The second day of the FDA devices panel looking at drug-eluting stents (DES) was the scene of...
Following pharma, GMD set to provide device 'generics'.
December 12, 2006... Following pharma, GMD set to provide device 'generics'
By AMANDA PEDERSEN
Medical Device Daily Staff Writer
At a time when rising healthcare costs make headlines almost daily, a new medical device company has set out to respond to...
Report from Europe.
December 12, 2006... Report from Europe
Asset 2 electronic 'toolkit' new aid to stroke services in UK
A Medical Device Daily Staff Report
A new electronic "toolkit" for the staff of the National Health Service, launched by the UK Department of Health,...
Financings roundup.
December 12, 2006... Financings roundup
Galil adds $52M in financing and completes Oncura deals
By DON LONG
Medical Device Daily Managing Editor
Galil Medical (Tel Aviv, Israel), one of the companies owned by Elron Electronic (also Tel Aviv),...