Medical Device Week articles from September 2005

Medical Device Week archives from September 2005

MIVT reports milestone with two new U.S. patent filings.
September 1, 2005... MIVT reports milestone with two new U.S. patent filings By HOLLAND JOHNSON Medical Device Daily Associate Managing Editor MIV Therapeutics (MIVT; Vancouver, British Columbia), a developer of next-generation biocompatible passive...

iCAD results positive in study published in <I>Cancer</I> journal.
September 1, 2005... iCAD results positive in study published in Cancer journal A Medical Device Daily Staff Report iCAD (Nashua, New Hampshire), a provider of computer-aided detection (CAD) solutions that are designed to enable healthcare professionals to...

Report from Israel.(Israeli plans to develop intellectual property)
September 1, 2005... Report from Israel Government launches private development of public IP By RAE FISHMAN Medical Device Daily Correspondent ZICHRON YAAKOV, Israel - Following 18 months of intense, high-level preparations, Israel is about to...

FDA official exits over delay of decision on Plan B pill.
September 1, 2005... FDA official exits over delay of decision on Plan B pill By CHRISTOPHER DELPORTE Medical Device Daily Washington Editor WASHINGTON - A high-ranking FDA official resigned Wednesday, citing the agency's plan to postpone a decision on...

Financings roundup.(medical equipment industry)
September 1, 2005... Financings roundup Boston Life Sciences in pact for $12.7M; ISTO raises $10.8M A Medical Device Daily Staff Report Boston Life Sciences (Boston) said that it has entered into a common stock purchase agreement with a group of...

Deals roundup.(medical equipment industry)
September 1, 2005... Deals roundup McKesson finishes D&K deal; ISS backs Novoste-ONI merger A Medical Device Daily Staff Report McKesson (San Francisco) reported completing its acquisition of D & K Healthcare Resources (St. Louis), a distributor of...

Briefly Noted.
September 1, 2005... Briefly Noted Cyberquest becomes Vein Associates of America Cyberquest (Orlando, Florida) reported that it has changed its name to Vein Associates of America and will begin trading under the new stock symbol VNAA, effective...

Court report.(Angeion versus Medmarc Casualty Insurance Co.)
September 1, 2005... Court report Angeion secures motion for judgment against Medmarc A Medical Device Daily Staff Report Angeion (St. Paul, Minnesota) reported that in an Aug. 25 order, Judge David Doty of the U.S. District Court for the District of...

Yaniv hails new policy, but raps past 'failure of vision'.
September 1, 2005... Yaniv hails new policy, but raps past 'failure of vision' Medical Device Daily asked Zvi Yaniv, president and CEO of Applied Nanotech, a subsidiary of Nano-Proprietary (both Austin, Texas), where Yaniv is president and COO, to comment on...

People in Places.(Integrated Healthcare Systems)(Brief Article)
September 1, 2005... People in Places * Patrick Jensen, PhD, has been named executive vice president of engineering at Integrated Healthcare Systems (IHS; Seattle).He has more than 15 years of medical technology and commercialization experience in similar...

Product Briefs.
September 1, 2005... Product Briefs * Altea Therapeutics (Atlanta), which is focused on developing pharmaceutical products based on a new class of advanced transdermal patches that deliver sustained therapeutic levels of proteins and highly water-soluble...

Holiday notice.
September 2, 2005... Holiday notice Medical Device Daily's offices will be closed on Monday, Sept. 5, in observance of the Labor Day holiday in the U.S. No issue will be published that day. The next issue of MDD will be published Tuesday, Sept. 6. ...

Studies on use of Cyberonics' VNS therapy in TRD published.
September 2, 2005... Studies on use of Cyberonics' VNS therapy in TRD published By HOLLAND JOHNSON Medical Device Daily Associate Managing Editor Many questions about the effectiveness and safety of the Cyberonics (Houston) vagus nerve stimulation...

Deals roundup.(Cardiac Science and Quinton Cardiology Systems merge to from Cardiac Science Corp.)(National Vision shares offer by Vision Acquisition Corp.)(Tenet Healthcare sells Brotman Medical Center)
September 2, 2005... Deals roundup Cardiac Science and Quinton merge after shareholder OK A Medical Device Daily Staff Report Cardiac Science (Irvine, California) and Quinton Cardiology Systems (Bothell, Washington), two companies that make a variety...

Report from Europe.
September 2, 2005... Report from Europe Chaska acquires distributor, will direct-market in France A Medical Device Daily Staff Report Lifecore Biomedical (Chaska, Minnesota) said it has acquired its former distributor in France, Bardo-Biotech SAS...

NIH finalizes its new ethics guidelines, featuring changes.
September 2, 2005... NIH finalizes its new ethics guidelines, featuring changes By AARON LORENZO Medical Device Daily Washington Writer WASHINGTON &#8211; Pulling back slightly from an earlier plan, the National Institutes of Health (NIH; Bethesda,...

Chiron gets green light for flu vaccine; GSK enters fray.
September 2, 2005... Chiron gets green light for flu vaccine; GSK enters fray By KAREN PIHL-CAREY Medical Device Daily Staff Writer Clearing the path to manufacture flu vaccine for the 2005-2006 influenza season, Chiron (Emeryville, California)...

Financings roundup.
September 2, 2005... Financings roundup Intraop gets debenture funds; Microvision adds private $1.5M A Medical Device Daily Staff Report Intraop Medical (Santa Clara, California) reported that it has issued $2.5 million of 7% convertible debentures and...

Grants/contracts.
September 2, 2005... Grants/contracts Haemonetics ends OrthoPAT distribution pact with Zimmer A Medical Device Daily Staff Report Haemonetics (Braintree, Massachusetts), a manufacturer of automated blood-processing systems, reported that it would end...

Court report.
September 2, 2005... Court report Stratagene is found guilty of infringing Third Wave patents A Medical Device Daily Staff Report Molecular diagnostics developer Third Wave Technologies (Madison, Wisconsin) reported that a federal jury has found...

Briefly Noted.(Cyberquest Vascular Relief Centers contracts with Cutler Law Group)(Immucor restates profit)(Brief Article)
September 2, 2005... Briefly Noted Vascular Relief Centers retain Cutler Law Cyberquest Vascular Relief Centers (Orlando, Florida) has retained legal services from the Cutler Law Group (Augusta, Georgia), a law firm specializing in national and...

People in Places.
September 2, 2005... People in Places &#8226; Mathew Hahn, PhD, has been named chief science & technology officer of Accelrys (San Diego). Hahn joined predecessor company Molecular Simulations in 1989, leaving in 1999 to co-found SciTegic. Accelrys acquired...

Product Briefs.
September 2, 2005... Product Briefs &#8226; Alcatel (Calabasas, California), a provider of communication solutions, reported the availability of an integrated voice, data and video communication solution package for healthcare providers. This end-to-end...

Boston Scientific launches new cool ablation catheter to treat VT.
September 6, 2005... Boston Scientific launches new cool ablation catheter to treat VT By HOLLAND JOHNSON Medical Device Daily Associate Managing Editor Boston Scientific (Natick, Massachusetts) reported the launch of the Chilli II Cooled Ablation...

Final rule on combo products should smooth review process.
September 6, 2005... More efficient, transparent Final rule on combo products should smooth review process By CHRISTOPHER DELPORTE Medical Device Daily Washington Editor WASHINGTON &#8211; A standard vision-correcting contact lens would be...

International report.
September 6, 2005... International report St. Jude receives approvals for two ICD lines in Japan A Medical Device Daily Staff Report St. Jude Medical (St. Paul, Minnesota) has reported receiving regulatory and reimbursement approvals from the Ministry...

Deals roundup.
September 6, 2005... Deals roundup MSA set to acquire Microsensor; Extendicare sells nursing homes A Medical Device Daily Staff Report MSA (Cranberry, Pennsylvania) said it has acquired Microsensor Systems (Bowling Green, Kentucky), a provider of...

Financings roundup.
September 6, 2005... Financings roundup Norwood Abbey raises $10M; Medtox warrants are exercised A Medical Device Daily Staff Report Norwood Abbey (Melbourne, Australia) reported that it has reached agreement with U.S. institutional investors to raise...

Hanger Orthopedic centers and 7 PT clinics damaged by storm.
September 6, 2005... Hanger Orthopedic centers and 7 PT clinics damaged by storm A Medical Device Daily Staff Report Hanger Orthopedic Group (Bethesda, Maryland) reported that a preliminary assessment shows that four patient care centers were damaged...

Court report.
September 6, 2005... Court report Smith & Nephew gets favorable patent ruling against Synthes A Medical Device Daily Staff Report Smith & Nephew Orthopaedics (S&N; Memphis, Tennessee) said that a U.S. District Court judge for the Western District of...

Grants/contracts.
September 6, 2005... Grants/contracts SonoSite, Teleflex, Siemens in Novation supplier accords A Medical Device Daily Staff Report SonoSite (Bothell, Washington), which focuses on hand-carried ultrasound, said it has signed a three-year, dual-source...

StemCells gets California manufacturing license.
September 6, 2005... StemCells gets California manufacturing license StemCells (Palo Alto, California) reported that it has received a manufacturing license for its cell-processing facility from the State of California Department of Health Services, Food and...

Product Briefs.
September 6, 2005... Product Briefs &#8226; Biotronik (Lake Oswego, Oregon) reported that the first U.S. implantation of its Lumos DR-T implantable cardioverter defibrillator (ICD) was performed at Loyola University Medical Center (Chicago) by Niraj Varma MD,...

People in Places.
September 6, 2005... People in Places &#8226; David Onions, PhD, has been promoted to the newly created position of chief medical officer of Invitrogen (Carlsbad, California). He will be responsible for guiding the company's scientific efforts as it moves into...

CryoLife reports first implants of spinal disc repair system.
September 7, 2005... CryoLife reports first implants of spinal disc repair system By HOLLAND JOHNSON Medical Device Daily Associate Managing Editor CryoLife (Kennesaw, Georgia), a biomaterials and biosurgical device company, reported that its BioDisc...

Syncope research among host of studies at Europe gathering.
September 7, 2005... ESC Congress 2005 Syncope research among host of studies at Europe gathering A Medical Device Daily Staff Report At the 2005 congress of the European Society of Cardiology (ESC; Sophia Antipolis, France) in Stockholm, Sweden,...

Report from Europe.(SpinX Technologies secures financing)(Britain's Department of Health launches computer system)
September 7, 2005... Report from Europe SpinX Tech adding $12.5M for &#8216;programmable microfluidics' A Medical Device Daily Staff Report SpinX Technologies (Geneva, Switzerland), a privately held company that has developed a programmable...

Financings roundup.(TopSpin Medical securities)(IntriCon closes on senior secured credit facilities)(Intermagnetics General syndicated credit facility)
September 7, 2005... Financings roundup TopSpin completes $8M IPO; Intricon adding $10M facility A Medical Device Daily Staff Report TopSpin Medical (Tel Aviv, Israel) reported completing an initial public offering on the Tel Aviv stock exchange,...

Bayer to donate blood glucose monitors and test strips as aid.
September 7, 2005... Hurricane Katrina relief efforts Bayer to donate blood glucose monitors and test strips as aid A Medical Device Daily Staff Report Healthcare giant Bayer (Pittsburgh) reported that it is preparing to ship more than 45,000 Ascensia...

Court report.
September 7, 2005... Court report Third Wave: status of PCR tech &#8216;galvanized' by $5.3M verdict A Medical Device Daily Staff Report Third Wave Technologies (Madison, Wisconsin) reported that a federal jury has found life science research provider...

Grants/contracts.
September 7, 2005... Grants/contracts Alpha Innotech in imaging pact with GE Healthcare A Medical Device Daily Staff Report Alpha Innotech (San Leandro, California) reported that it has entered into a license and supply agreement with GE Healthcare...

Deals roundup.
September 7, 2005... Deals roundup Dade Behring to buy diagnostic assets of India's Ranbaxy Labs A Medical Device Daily Staff Report Dade Behring (Deerfield, Illinois) reported that it has reached an agreement to acquire certain medical diagnostic...

Briefly Noted.
September 7, 2005... Briefly Noted 1,000th PET installation for Siemens Siemens Medical Solutions (Malvern, Pennsylvania) reported the 1,000th installation of its positron emission tomography (PET) technology. The sale of the hybrid PET/computed tomography...

Product Briefs.
September 7, 2005... Product Briefs &#8226; Inovio Biomedical (San Diego) reported that a presentation highlighting the applicability of its MedPulser selective electrochemical tumor ablation system to treat melanoma will take place at the 6th World Congress...

People in Places.
September 7, 2005... People in Places &#8226; MicroDental Laboratories (Dublin, California), a cosmetic dentistry laboratory and makers of MAC Veneers, reported a restructuring of customer relations into three groups, intended, it said, to better serve the...

Arthrocare, S&N settle suits, enter supply/license accords.
September 8, 2005... Arthrocare, S&N settle suits, enter supply/license accords By HOLLAND JOHNSON Medical Device Daily Associate Managing Editor After a slew of lawsuits and countersuits dating back to 2001, ArthroCare (Austin, Texas) and Smith &...

FDA releases draft guidance relating to CLIA waivers.
September 8, 2005... FDA releases draft guidance relating to CLIA waivers By KAREN YOUNG Medical Device Daily Staff Writer The FDA has released its draft guidance for industry and staff concerning recommendations for Clinical Laboratory Improvement...

Report from Europe.
September 8, 2005... Report from Europe Adlyfe is awarded UK grant for prion disease test work A Medical Device Daily Staff Report Adlyfe (Rockville, Maryland), a privately held firm that is focused on early diagnostics for animal and human brain...

Deals roundup.
September 8, 2005... Deals roundup Eye Dynamics to be AcuNetx after merger with OrthoNetx A Medical Device Daily Staff Report Eye Dynamics (Torrance, California) reported that it has agreed to a merger with OrthoNetx (Superior, Colorado), a provider of...

Access Point Medical is new entry in HME market in U.S.
September 8, 2005... Access Point Medical is new entry in HME market in U.S. A Medical Device Daily Staff Report Access Point Medical (APM; St. Louis) reported that it has entered the U.S. home care market as a manufacturer of home medical equipment (HME)....

Briefly Noted.(ViroLogic changes name to Monogram Biosciences)(number of drugs withdrawn for safety reasons not rising)(DemeTACH joins Global Healthcare Exchange)
September 8, 2005... Briefly Noted Name changed to Monogram Biosciences ViroLogic (South San Francisco, California) reported that it is changing its name to Monogram Biosciences. Effective Wednesday, the company's common stock began trading under the...

Study boosts ECG processing by Israeli firm's HyperQ unit.
September 8, 2005... ESC Congress 2005 Study boosts ECG processing by Israeli firm's HyperQ unit A Medical Device Daily Staff Report Biological Signal Processing (BPS; Tel Aviv, Israel) presented the results from a large-scale clinical study of its...

Financings roundup.
September 8, 2005... Financings roundup Insight may offer $250M in notes; Mediscience eyes $6M to $10M A Medical Device Daily Staff Report InSight Health Services (Lake Forest, California), a nationwide provider of diagnostic imaging services, reported...

Grants/contracts.
September 8, 2005... Grants/contracts Albany Molecular renews pact with GE Healthcare on materials A Medical Device Daily Staff Report Albany Molecular Research (Albany, New York) reported the renewal of a manufacturing agreement with GE Healthcare...

Product Briefs.
September 8, 2005... Product Briefs * Advanced Medical Optics (Santa Ana, California), reported that it has received FDA approval to treat high myopia and myopic astigmatism with the Star S4 IR Excimer Laser System with the CustomVue procedure. The indications...

Moderate Plus Profile breast implants launched by Mentor.
September 8, 2005... Moderate Plus Profile breast implants launched by Mentor A Medical Device Daily Staff Report Mentor (Santa Barbara, California) reported launch of its new Moderate Plus Profile saline-filled breast implant product line in the U.S. The...

GE Healthcare funds AOSSM's articular cartilage repair study.
September 9, 2005... GE Healthcare funds AOSSM's articular cartilage repair study By DON LONG Medical Device Daily Managing Editor With the launch of National Football League play last night, a number of high-priced, high-profile professional athletes...

APNS submits pre-IDE for AD test as 1st step toward okay.
September 9, 2005... APNS submits pre-IDE for AD test as 1st step toward okay By HOLLAND JOHNSON Medical Device Daily Associate Managing Editor Applied NeuroSolutions (APNS; Vernon Hills, Illinois) has moved a step closer to becoming the first company...

Report from Europe.
September 9, 2005... Report from Europe Boston Sci receives CE mark for second-generation DES A Medical Device Daily Staff Report Boston Scientific (Natick, Massachusetts) said it has received the CE mark for its Taxus Liberte paclitaxel-eluting stent...

Financings roundup.
September 9, 2005... Financings roundup Aurora V fund $50M is closed; Direct Flow Medical adds $8M A Medical Device Daily Staff Report The Aurora Funds (Research Triangle Park, North Carolina) yesterday reported the first closing of its fifth venture...

Court report.
September 9, 2005... Court report Court rejects Nellcor appeal in patent dispute with Masimo A Medical Device Daily Staff Report A U.S. appeals court in Los Angeles has upheld a $164.2 million verdict against Nellcor (Pleasanton, California), a...

GEO Group subsidiary changes name.(Atlantic Shores Healthcare now GEO Care)(Brief Article)
September 9, 2005... GEO Group subsidiary changes name The GEO Group (Boca Raton, Florida) reported that its wholly owned subsidiary, Atlantic Shores Healthcare, has changed its corporate name to GEO Care, effective Aug. 19, upon the filing of an amendment to...

Dialysis firms said expending &#8216;great effort' in Katrina relief.
September 9, 2005... Dialysis firms said expending &#8216;great effort' in Katrina relief A Medical Device Daily Staff Report The Renal Leadership Council (Washington) reported that the four largest companies that provide dialysis care in the U.S,.&#8211;...

Deals roundup.
September 9, 2005... Deals roundup Caliper agrees to $22M deal to acquire NovaScreen Bio A Medical Device Daily Staff Report Caliper Life Sciences (Hopkinton, Massachusetts) reported that it has entered into a definitive agreement to acquire NovaScreen...

Virtual colonoscopy coverage OK in some cases in 4 states.
September 9, 2005... Virtual colonoscopy coverage OK in some cases in 4 states By KAREN YOUNG Medical Device Daily Staff Writer Wisconsin Physicians Service Insurance (WPSI; Madison, Wisconsin) has reported that four states in the Midwest have been...

Briefly Noted.
September 9, 2005... Briefly Noted DOBI hosts international symposium DOBI Medical International (Mahwah, New Jersey) is holding its 2nd annual European Symposium in Optical Breast Imaging today through Sunday in Prague, the Czech Republic. The...

Product Briefs.
September 9, 2005... Product Briefs &#8226; BioElectronics (Frederick, Maryland) said it has received market clearance from Health Canada for its disposable ActiPatch for the relief of pain associated with musculoskeletal complaints. ActiPatch is a drug-free...

Panel thumbs-up for Exubera a big boost to Nektar inhaler.
September 12, 2005... FDA roundup Panel thumbs-up for Exubera a big boost to Nektar inhaler By DON LONG Medical Device Daily Managing Editor With an important FDA panel advisory vote last week, a potential blockbuster drug could potentially produce...

CeraPedics files IDE for trial of P-15 Putty in spine fusions.
September 12, 2005... CeraPedics files IDE for trial of P-15 Putty in spine fusions By HOLLAND JOHNSON Medical Device Daily Associate Managing Editor Adding to a growing list of companies developing growth factors &#8211; the pun intended &#8211;...

International report.
September 12, 2005... International report Kyphon gets OK for Japanese trial of kyphoplasty procedure A Medical Device Daily Staff Report Kyphon (Sunnyvale, California) said last week that it has received approval from the Japan Ministry of Health,...

Xenogen launches IVIS 3-D imaging at SMI conference.
September 12, 2005... Xenogen launches IVIS 3-D imaging at SMI conference By KAREN YOUNG Medical Device Daily Staff Writer Xenogen (Alameda, California) last week launched its IVIS 3D Imaging System, which it said is the first 3-D biophotonic imaging...

Court report.
September 12, 2005... Court report Radiologist files AAA patent complaint vs. Boston Sci A Medical Device Daily Staff Report Shaun Samuels, MD, an interventional radiologist from Miami, has filed a complaint in U.S. District Court in Marshall, Texas,...

Device, pharma and service firms join Katrina relief effort.
September 12, 2005... Device, pharma and service firms join Katrina relief effort A Medical Device Daily Staff Report In the wake of Hurricane Katrina, medical device, pharmaceutical, medical services and life science firms continued to provide donations to...

Financings roundup.
September 12, 2005... Financings roundup AB to sell $900M in notes; Sutura closes on $7M funding A Medical Device Daily Staff Report AmerisourceBergen (AB; Valley Forge, Pennsylvania) reported that it has agreed to sell $500 million of senior notes due...

Grants/contracts.
September 12, 2005... Grants/contracts Hanger Orthopedic in orthotic, prosthetic accord with Cigna A Medical Device Daily Staff Report Hanger Orthopedic Group (Bethesda, Maryland), through its wholly owned subsidiary, Linkia (Rockville, Maryland), a...

Deals roundup.
September 12, 2005... Deals roundup Wizzard closes on Interim buy; CHS set to add Sunbury Hospital A Medical Device Daily Staff Report Wizzard Software (Pittsburgh) reported that it has closed its acquisition of Interim Health Care of Wyoming (Casper,...

Product Briefs.
September 12, 2005... Product Briefs &#8226; IntraLase (Irvine, California), a manufacture of ultra-fast lasers, related software and disposable devices used to create a corneal flap, the first step in LASIK surgery for the correction of vision, said it has...

New report on FDA delays adds urgency to HRS safety meeting.
September 13, 2005... New report on FDA delays adds urgency to HRS safety meeting By DON LONG Medical Device Daily Managing Editor A new report indicating a three-month or more delay in the FDA's notification to physicians and the public concerning...

After delay, CABG Medical able to begin European trial.
September 13, 2005... After delay, CABG Medical able to begin European trial By HOLLAND JOHNSON Medical Device Daily Associate Managing Editor CABG Medical (Minneapolis) reported the commencement of enrollment in its European clinical trial of the Holly...

Report from Europe.
September 13, 2005... Report from Europe F&S says capital constraints impacting imaging market A Medical Device Daily Staff Report International consulting firm Frost & Sullivan (F&S; London) said the European market for key medical imaging modalities...

VivoMetrics LifeShirt used to study 9/11 post-trauma stress.
September 13, 2005... VivoMetrics' LifeShirt used to study 9/11 post-trauma stress By KAREN YOUNG Medical Device Daily Staff Writer VivoMetrics' (Ventura, California) by now well-known LifeShirt is being used in a study to help determine the effects of...

Washington roundup.
September 13, 2005... Washington roundup HHS accelerates funding for new hurricane health centers A Medical Device Daily Staff Report Mike Leavitt, secretary of the Department of Health and Human Services, reported that the federal government would...

Clarification.(Correction Notice)
September 13, 2005... Clarification In a story on CeraPedics (Lakewood, Colorado) that appeared in the Sept. 12 issue of MDD, it was reported erroneously that a pivotal study planned by the company for its P-15 Putty would compare that compound to autograft....

Deals roundup.
September 13, 2005... Deals roundup National Vision tender offer finalized; deal doubles ALC A Medical Device Daily Staff Report National Vision (Lawrenceville, Georgia), an operator of retail vision centers, and Berkshire Partners reported the final...