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Venture capital panel cites ortho sector funding 'hoops'.
November 1, 2005... 2005 Medical Innovation Summit
Venture capital panel cites ortho sector funding 'hoops'
By HOLLAND JOHNSON
Medical Device Daily Associate Managing Editor
CLEVELAND -- In the orthopedics field, as in any other sector of...
Innovative technologies abound in arena occupied by surgeons.
November 1, 2005... Innovative technologies abound in arena occupied by surgeons
By DIANA TUCKER
Medical Device Daily Contributing Writer
SAN FRANCISCO -- Although many innovative technologies were presented during the 91st clinical congress of the...
Report from Europe.
November 1, 2005... Report from Europe
St. Jude gets CE mark for its Victory family of pacemakers
A Medical Device Daily Staff Report
St. Jude Medical (St. Paul, Minnesota) has received CE-mark approval for its Victory pacemaker family, which allows...
Financings roundup.
November 1, 2005... Financings roundup
SpineMedica gathers $10.6M in Series A private placement
A Medical Device Daily Staff Report
SpineMedica, a Florida medical device corporation developing an artificial disc implant called SaluDisc, reported...
Washington roundup.
November 1, 2005... Washington roundup
BIO files lawsuit against DC over pending price-control bill
By AARON LORENZO
Medical Device Daily Washington Writer
WASHINGTON -- In an issue that should resonate with medical device manufacturers, the...
Deals roundup.
November 1, 2005... Deals roundup
Novartis to buy rest of Chiron shares for $5.1 billion in cash
A Medical Device Daily Staff Report
Chiron (Emeryville, California) has entered into a definitive merger agreement with Novartis (Basel, Switzerland)...
Briefly Noted.
November 1, 2005... Briefly Noted
Electric Mobility earns JCAHO accreditation
Electric Mobility (Sewell, New Jersey), distributor of the "Rascal" powerchair and scooter, reported that its Rascal Insurance Services division has earned the Joint Commission...
Court report.
November 1, 2005... Court report
Scrushy pleads 'not guilty' to new charges of bribery
A Medical Device Daily Staff Report
Richard Scrushy, founder and former CEO of HealthSouth (Birmingham, Alabama), last week pleaded not guilty to new charges...
People in Places.
November 1, 2005... People in Places
* Scott Moonly, PhD, has been appointed vice president, life science investments for Brookstone Capital (Las Vegas). In his former position as a consultant with L.E.K. Consulting, Moonly address strategy issues for medical...
Product Briefs.
November 1, 2005... Product Briefs
* BARRX Medical (Sunnyvale, California) said results of a study presented by Virender Sharma, MD, of the Mayo Clinic (Scottsdale, Arizona), evaluating the safety, tolerability and effectiveness of the company's HALO360...
AtriCure reports first patient treated in Bipolar system trial.
November 1, 2005... AtriCure reports first patient treated in Bipolar system trial
A Medical Device Daily Staff Report
AtriCure (West Chester, Ohio) reported the first pati-ent treated in its RESTORE-SR II clinical study for the use of the AtriCure Bipolar...
Deals roundup.(medical equipment industry)
November 2, 2005... Deals roundup
FTC approval of J&J/Guidant deal would push pricing talks
A Medical Device Daily Staff Report
The Federal Trade Commission (FTC; Washington) is reportedly set to approve the acquisition of Guidant (Indianapolis) by...
VC money flowing at strong pace into life sciences firms.
November 2, 2005... VC money flowing at strong pace into life sciences firms
By AARON LORENZO
Medical Device Daily Washington Writer
Venture capitalists are putting money into life sciences companies at a clip that could meet or exceed last year's...
Report from Europe.(National Health Service)
November 2, 2005... Report from Europe
UK eyes framework for new, much faster patient pathway
A Medical Device Daily Staff Report
UK Health Secretary Patricia Hewitt last week gave a few added details on the program under which the National Health...
Celleration in $20M 'C' round; PerkinElmer inks new facility.
November 2, 2005... Celleration in $20M 'C' round; PerkinElmer inks new facility
A Medical Device Daily Staff Report
Celleration (Eden Prairie, Minnesota), developer of a non-contact ultrasound therapy for chronic and hard-to-heal wounds, reported that it...
Washington roundup.(Boston Scientific reports reimbursement code approval for device)(Pall presents to FDA committee on transmissible spongiform encephalopathies)(Physician Voluntary Reporting Program)
November 2, 2005... Washington roundup
CMS in launch of Physician Voluntary Reporting Program
A Medical Device Daily Staff Report
WASHINGTON -- The Centers for Medicare & Medicaid Services (CMS; Baltimore) said last week that as part of its overall...
Grants/contracts.
November 2, 2005... Grants/contracts
LabCorp, Arcturus in licensing accord on CUP classification
A Medical Device Daily Staff Report
Laboratory Corporation of America (LabCorp; Burlington, North Carolina), which has a focus on oncology testing, said...
Court report.
November 2, 2005... Court report
BioForm settles dispute with Artes via payment, royalties
A Medical Device Daily Staff Report
BioForm Medical (San Diego), Artes Medical (San Mateo, California) and Dr. Martin Lemperle, one of the founders of Artes,...
Financings roundup.(Transgenomic completes stock placement)(Medicsight sells common stock)(Patient Infosystems raises cash from stock sale)
November 2, 2005... Financings roundup
Transgenomic in placement; Medicsight raises $7.5 million
A Medical Device Daily Staff Report
Transgenomic (Omaha, Nebraska) reported that it has completed a previously disclosed private placement of the...
Nanogen POC meets ISO requirements.
November 2, 2005... Nanogen POC meets ISO requirements
Nanogen (San Diego), a developer of diagnostic products, reported that the quality management system of its point-of-care division successfully meets the requirements of the International Organization for...
People in Places.(appointment and promotions at medical equipment industry)(Brief Article)
November 2, 2005... People in Places
* Hossein Arjomand has been promoted to vice president, research & development at Align Technology (Santa Clara, California), replacing Rok Sribar, who has left the company to pursue other interests. Arjomand, who joined...
Product Briefs.
November 2, 2005... Product Briefs
* EDAP TMS (Lyon, France) presented clinical data on the success of high-intensity focused ultrasound (HIFU) with its Ablatherm device at the 5th International Symposium on Therapeutic Ultrasound (ISTU) held at Harvard...
Despite FTC nod, J&J may scrap its planned deal for Guidant.(Johnson & Johnson)
November 3, 2005... Despite FTC nod, J&J may scrap its planned deal for Guidant
By HOLLAND JOHNSON
Medical Device Daily Associate Managing Editor
As expected, the Federal Trade Commission (FTC; Washington) has given conditional approval to Johnson &...
Emageon buys Camtronics for $40M; Sutura to spin off unit.(Pro-Dex acquires portion of IntraVantage)
November 3, 2005... Emageon buys Camtronics for $40M; Sutura to spin off unit
A Medical Device Daily Staff Report
Emageon (Birmingham, Alabama) has acquired from Analogic (Peabody, Massachusetts) all the stock of that company's wholly owned subsidiary,...
Report from Europe.
November 3, 2005... Report from Europe
Eucomed pushes for reform of Japanese regulatory process
A Medical Device Daily Staff Report
Eucomed (Brussels, Belgium), the European medical technology trade association, issued a statement Wednesday urging the...
Briefly Noted.
November 3, 2005... Briefly Noted
Medtronic awards $100M to its foundation
Medtronic (Minneapolis) reported that its board approved and the company awarded last week a $100 million donation to the Medtronic Foundation. The donation will be used to...
GE Healthcare/Volcano in joint digital cath, IVUS development.(intravascular ultrasound imaging)
November 3, 2005... GE Healthcare/Volcano in joint digital cath, IVUS development
By KAREN YOUNG
Medical Device Daily Staff Writer
In an agreement that had its beginnings with discussions late last year, GE Healthcare (Waukesha, Wisconsin) and Volcano...
Court report.
November 3, 2005... Court report
CTT says U.S. Supreme Court will hear LabCorp's appeal
A Medical Device Daily Staff Report
Competitive Technologies (CTT; Fairfield, Connecticut) reported that the U.S. Supreme Court has agreed to hear an appeal by...
Financings roundup.
November 3, 2005... Financings roundup
Devax in $32 million 'D' round; HemoSense in $10M share sale
A Medical Device Daily Staff Report
Devax (Irvine, California), an emerging medical device company developing a drug-eluting stent for the treatment...
Deals roundup.(Company Profile)
November 3, 2005... Deals roundup
Access Point buys scooter, wheelchair lines from Bruno
A Medical Device Daily Staff Report
Access Point Medical (APM; St. Louis) reported purchasing the scooter and power wheelchair product lines of Bruno Independent...
Grants/contracts.
November 3, 2005... Grants/contracts
Confirma in 3-year pact with Amerinet for CAD for MRI
A Medical Device Daily Staff Report
Confirma (Kirkland, Washington), which focuses on computer-aided detection (CAD) for MRI, reported a three-year agreement...
Product Briefs.
November 3, 2005... Product Briefs
* Candela (Wayland, Massachusetts) has introduced a new Pulsed Dye Laser Platform featuring three new models -- the Aesthetica, the Platinum and the Perfecta. The company said customers can easily upgrade to the next version...
People in Places.(appointments at medical equipment industry)(Brief Article)
November 3, 2005... People in Places
* Sebastian Meyer-Plath has been appointed vice president for the nuclear, biological and chemical (NBC) detection business of Bruker Daltonics (Billerica, Massachusetts). Meyer-Plath had originally joined Bruker in 1993,...
Perceptronix studying buccal mucosa test for lung cancer.
November 4, 2005... American College of Chest Physicians
Perceptronix studying buccal mucosa test for lung cancer
By KAREN YOUNG
Medical Device Daily Staff Writer
Perceptronix (Vancouver, British Columbia) presented results of a new study that...
CoAxia's NeuroFlo may widen 'window' for stroke treatment.
November 4, 2005... CoAxia's NeuroFlo may widen 'window' for stroke treatment
By HOLLAND JOHNSON
Medical Device Daily Associate Managing Editor
Three hours. That's the generally acknowledged window of time in which a stroke patient can now be treated...
Report from Europe.
November 4, 2005... Report from Europe
WorldHeart eyes early '06 start of rotary VAD human clinicals
A Medical Device Daily Staff Report
WorldHeart (Oakland, California) said it has been notified by St. Luke's Hospital's (Thessaloniki, Greece) Ethics...
Deals roundup.(mergers, acquisitions in medical equipment industry)
November 4, 2005... Deals roundup
Angiotech in agreement to buy Edwards' Lifespan line for $14M
A Medical Device Daily Staff Report
Angiotech Pharmaceuticals (Vancouver, British Columbia) reported yesterday that it has entered into a definitive...
Court report.
November 4, 2005... Court report
New York attorney general files fraud suit vs. Guidant
A Medical Device Daily Staff Report
Guidant (Indianapolis) this week was on the receiving end of still another lawsuit, this one filed by the State of New York,...
Financings roundup.
November 4, 2005... Financings roundup
$30M funding to boost firm's implanted glucose monitor R&D
A Medical Device Daily Staff Report
Sensors for Medicine and Science (SMS; Germantown, Maryland) said it has completed the second closing of a private...
Washington roundup.
November 4, 2005... Washington roundup
8th coverage/reimbursement conference is set by MDMA
A Medical Device Daily Staff Report
The Medical Device Manufacturers Association (MDMA; Washington), one of the earliest proponents of medical device companies...
Grants/contracts.
November 4, 2005... Grants/contracts
IRIS International in distribution pact with Abbott Molecular unit
A Medical Device Daily Staff Writer
IRIS International (Chatsworth, California), a manufacturer and marketer of automated IVD urinalysis systems...
People in Places.(appointments at medical equipment industry)
November 4, 2005... People in Places
* Richard Setzer will join Allied Healthcare Products (St. Louis) as vice president of sales and marketing. Most recently, Setzer was global integration manager of the Health Imaging Division of Eastman Kodak. He replaces...
Isolagen in separation/release accord with former chairman.
November 4, 2005... Isolagen in separation/release accord with former chairman
A Medical Device Daily Staff Report
Frank DeLape has resigned as chairman of the board of Isolagen (Exagen, Pennsylvania) and as a director, terminating his employment with the...
Product Briefs.
November 4, 2005... Product Briefs
* Gamma Medica-Ideas (Northridge, California), which is developing a new class of imaging systems that integrate multiple modalities to create more powerful diagnostic capabilities, said researchers from Harvard Medical...
Corautus Genetics granted Fast Track status for VEGF-2.
November 4, 2005... Corautus Genetics granted Fast Track status for VEGF-2
A Medical Device Daily Staff Report
Corautus Genetics (Atlanta), a clinical-stage biopharmaceutical company, reported that the FDA has granted Fast Track status for its Vascular...
FDA panel backs idea of OTC sale of OraSure's HIV tests.
November 7, 2005... FDA panel backs idea of OTC sale of OraSure's HIV tests
By AARON LORENZO
Medical Device Daily Washington Writer
GAITHERSBURG, Maryland -- An FDA advisory panel last week came down in favor of eventual over-the-counter (OTC) sales...
Deals roundup dddd<META NAME="TAG" VALUE="Medical Devices">.
November 7, 2005... Deals roundup
Olympus partners with Cytori, forming regenerative med j-v
By RANDALL OSBORNE
Medical Device Daily Staff Writers
and Staff Reports
Cytori Therapeutics (San Diego) reported the formation of a regenerative...
International report.
November 7, 2005... International report
Medicsight to begin studies in China on CAD products
A Medical Device Daily Staff Report
Medicsight plc (London), a developer of computer-aided detection (CAD) software, said it will begin a clinical studies...
Anaplastology blends science, art in facial prosthetics niche.(Medical Art Prosthetics Clinic)
November 7, 2005... Anaplastology blends science, art in facial prosthetics niche
By KIM URQUHART
Medical Device Daily Staff Writer
The prosthetic eyelids and fingers designed by anaplastologist Greg Gion may be passive -- meaning they don't blink or...
Immucor to cut regulatory costs by closing Houston facility.
November 7, 2005... Immucor to cut regulatory costs by closing Houston facility
A Medical Device Daily Staff Report
Saying that it needs to reduce the regulatory burden posed by operating two separate FDA-licensed facilities, Immucor (Norcross, Georgia),...
Briefly Noted.
November 7, 2005... Briefly Noted
B&L delays quarterly filing
Bausch & Lomb (B&L; Rochester, New York) on Friday said it has notified the Securities and Exchange Commission that it would delay the filing of its quarterly report ended Sept. 24 in order for...
Grants/contracts.
November 7, 2005... Grants/contracts
$5M in tax breaks to boost Zimmer's R&D infrastructure
A Medical Device Daily Staff Report
Zimmer Holdings (Warsaw, Indiana) and Indiana Gov. Mitch Daniels on Friday reported that that state plans to grant more...
Washington roundup.
November 7, 2005... Washington roundup
CMS demonstration project aimed at ESRD patient care
A Medical Device Daily Staff Report
WASHINGTON -- The Centers for Medicare & Medicaid Services (CMS; Baltimore) has selected two organizations to participate...
Financings roundup.
November 7, 2005... Financings roundup
Endocare adds $4M credit line; Synapse gets JumpStart funds
A Medical Device Daily Staff Report
Endocare (Irvine, California), which is focused on the development of minimally invasive technologies for tissue and...
People in Places.
November 7, 2005... People in Places
* Luther Nussbaum has resigned as CEO, chairman, and director of First Consulting Group (FCG; Long Beach, California), effective immediately. Douglas Bergeron, a director of the company since August 2004, has been...
Product Briefs.
November 7, 2005... Product Briefs
* ChondroGene (Toronto), focused on the application of functional genomics to enable early diagnosis and personalized therapeutic intervention based on disease-specific biomarkers, said that its paper titled "Blood-based...
Spurned Guidant files lawsuit vs. J&J to consummate merger.(Johnson & Johnson )
November 8, 2005... Spurned Guidant files lawsuit vs. J&J to consummate merger
By HOLLAND JOHNSON
Medical Device Daily Associate Managing Editor
It appears that the $25.4 billion marriage of Guidant (Indianapolis) and Johnson & Johnson (J&J; New...
Financings roundup.(health care)
November 8, 2005... Financings roundup
Aperio closes $17M 'B' round; HemoSense raises private $10M
A Medical Device Daily Staff Report
Aperio Technologies (Vista, California), a provider of virtual microscopy systems in the Healthcare IT industry,...
Report from Europe.
November 8, 2005... Report from Europe
Kodak health group selected for Finland's e-health project
A Medical Device Daily Staff Report
Eastman Kodak's Health Group (Rochester, New York) reported being selected as the main supplier of the RATU e-health...
Purdue researchers study gold nanorods for contrast imaging.
November 8, 2005... Purdue researchers study gold nanorods for contrast imaging
By KAREN YOUNG
Medical Device Daily Staff Writer
Researchers at Purdue University (West Lafayette, Indiana) are working on the development of what the university calls a...
Map of changes promises to unmask multitude of genes.
November 8, 2005... Map of changes promises to unmask multitude of genes
By SHARON KINGMAN
Medical Device Daily Contributing Writer
LONDON -- While the Human Genome Project documented the 99.9% of the genome that is common to all of us, the...
Deals roundup.(medical equipment industry)
November 8, 2005... Deals roundup
Owens & Minor acquires iCare; VirtualScopics in merger
A Medical Device Daily Staff Report
Owens & Minor (O&M; Richmond, Virginia) reported that its subsidiary Access Diabetic Supply has acquired certain operating...
Grants/contracts.
November 8, 2005... Grants/contracts
Deal puts Invivo's DynaCAD into Siemens' Magnetom MRI
A Medical Device Daily Staff Report
Siemens Medical Solutions (Malvern, Pennsylvania) and Invivo (Pewaukee, Wisconsin), a subsidiary of Intermagnetics General,...
Court report.
November 8, 2005... Court report
Applied Bio to take $2.4 million charge as result of arbitration
A Medical Device Daily Staff Report
Applied Biosystems (Foster City, California) said that it will record a pre-tax decrease of about $20.4 million to...
Product Briefs.(Refractec presents results for NearVision CK treatment)(Uroplasty receives FDA clearance for Urgent PC Neuromodulation System)(Welch Allyn introduces electrocardiographs)
November 8, 2005... Product Briefs
* Refractec (Irvine, California) reported preliminary clinical results presented at the recent American Academy of Ophthalmology (AAO; San Francisco) meeting in Chicago affirming the safety and efficacy of its NearVision CK...
People in Places.(appointments and promotions at medical industry)(Brief Article)
November 8, 2005... People in Places
* Brent McCarty, executive vice president and chief operating officer of Accuro Healthcare Solutions (Dallas), has been promoted to president of the company. He will remain chief operating officer. Before coming to Accuro,...
Companies rushing to roll out new tests to detect avian flu.
November 9, 2005... Companies rushing to roll out new tests to detect avian flu
By KAREN YOUNG
Medical Device Daily Staff Writer
As the avian flu virus gradually spreads worldwide, diagnostic firms are gearing up to meet the challenge.
Qiagen...
Deals roundup.(mergers, acquisitions in medical equipment industry)
November 9, 2005... Deals roundup
Varian's buy of Polymer Labs is valued at up to $65 million
By HOLLAND JOHNSON
Medical Device Daily Associate Managing Editor
Life science company Varian (Palo Alto, California) reported that it has acquired PL...
Report from Europe.
November 9, 2005... Report from Europe
Thoratec to launch HeartMate II in Europe with CE mark okay
A Medical Device Daily Staff Report
Thoratec (Pleasanton, California) reported that it has won CE-marking for its HeartMate II Left Ventricular Assist...
Center showcases hybrid OR for 'sighted' cardiac surgery.
November 9, 2005... Center showcases hybrid OR for 'sighted' cardiac surgery
By CYNTHIA DRAKE, RN
Medical Device Daily Contributing Writer
The state-of-the art hybrid operating room/cath lab of Vanderbilt University Medical Center (Nashville,...
Clinical results 'too good to be true,' most likely are.
November 9, 2005... A Number Is Worth A Thousand Words
Clinical results 'too good to be true,' most likely are
By ANETTE BREINDL
Medical Device Daily Contributing Science Writer
Clinical trials that show a treatment effect early on face a...
Financings roundup.
November 9, 2005... Financings roundup
Clearant set to raise $12 million; ThermoGenesis in OEM accord
A Medical Device Daily Staff Report
Clearant (Los Angeles), the developer of the Clearant Process for pathogen inactivation, said it has signed...
Briefly Noted.
November 9, 2005... Briefly Noted
CRF relocates within Waltham
CRF (Waltham, Massachusetts), which focuses on developing electronic Patient Reported Outcomes (e-PRO) and wireless data collection solutions for the biopharmaceutical industry, said that it...
Court report.
November 9, 2005... Court report
PerkinElmer says derivative class action suits are dismissed
A Medical Device Daily Staff Report
PerkinElmer (Boston) reported that the purported class-action and derivative lawsuits filed in July 2002 and June 2004...
Grants/contracts.
November 9, 2005... Grants/contracts
CMS awards Fresenius Medical subsidiary an ESRD program
A Medical Device Daily Staff Report
Toshiba America Medical Systems (TAMS; Tustin, California), which focuses on ultrasound technology, said it has entered an...
Product Briefs.
November 9, 2005... Product Briefs
* CPC of America (Sarasota, Florida) reported that its subsidiary, Med Enclosure, was informed by the FDA that its MedClose Vascular Closure System (VCS) would be regulated under the medical device regulations, and the lead...
People in Places.(appointments at medical equipment industry)
November 9, 2005... People in Places
* James Jeter has joined MedicalCV (Minneapolis) as the vice president of sales. Prior to MedicalCV, Jeter was a central states region manager for Medtronic. MedicalCV is a cardiovascular surgery company focused on...
Guidant issues enhanced CRM Product Performance report.
November 10, 2005... Guidant issues enhanced CRM Product Performance report
By HOLLAND JOHNSON
Medical Device Daily Associate Managing Editor
In the wake of recent problems with its pacemakers and implantable cardioverter defibrillators, Guidant...
Financings roundup.
November 10, 2005... Financings roundup
Versant closes $400M fund; FlowMedica in $15M 'D' round
A Medical Device Daily Staff Report
Healthcare venture capital firm Versant Ventures (Menlo Park, California) reported the closing of Versant Venture...
Report from Europe.
November 10, 2005... Report from Europe
Molecular mimic could lead to new immunotherapeutics
By Sharon Kingman
Medical Device Daily Contributing Writer
LONDON -- An artificial molecule that can activate a cell-surface receptor that plays a key...
SmartPill trial shows 'strong correlation' to scintigraphy.
November 10, 2005... SmartPill trial shows 'strong correlation' to scintigraphy
By KAREN YOUNG
Medical Device Daily Staff Writer
The SmartPill Corporation (Buffalo, New York), developer of the SmartPill pH.p Capsule, a non-invasive medical device that...
Web seminar zeroes in on SUD reprocessing debate.
November 10, 2005... Web seminar zeroes in on SUD reprocessing debate
By KAREN YOUNG
Medical Device Daily Staff Writer
On a much-reduced scale from most square-offs in Washington, it was one lawyer vs. another presenting differing points of view in a...
Grants/contracts.
November 10, 2005... Grants/contracts
Corgenix participating in $3.8M grant for tests of viral fevers
A Medical Device Daily Staff Report
Corgenix Medical (Denver), in partnership with Tulane University (New Orleans), the U.S. Army Medical Research...
Briefly Noted.(pharma markets)(Brief Article)
November 10, 2005... Briefly Noted
Hemosol not in compliance with Nasdaq
Hemosol (Toronto) said that on Nov. 3, was notified by the Nasdaq market that for the previous 30 consecutive business days, the bid price of its common stock closed below the minimum...