Medical Device Week articles from August 2005

Medical Device Week archives from August 2005

End of odyssey seems near for Staar's Visian myopia ICL.
August 1, 2005... Two companies win 'approvable' letters from FDA End of odyssey seems near for Staar's Visian myopia ICL By HOLLAND JOHNSON Medical Device Daily Associate Managing Editor After a lengthy process, struggling ophthalmologic device...

OK of Mentor's breast implant would reverse a 13-year ban.
August 1, 2005... Two companies win 'approvable' letters from FDA OK of Mentor's breast implant would reverse a 13-year ban By DON LONG Medical Device Daily Managing Editor The FDA late last week issued to Mentor (Santa Barbara, California) an...

International report.(Havana health congress)
August 1, 2005... International report Havana congress celebrates Cuba's biotech achievements By CORMAC SHERIDAN Medical Device Daily Correspondent and Staff Reports Every five years, the Centro Nacional de Investigaciones (CENIC), Cuba's...

Beckman Coulter studies new blood assay to identify BPH.(Company Profile)
August 1, 2005... American Association for Clinical Chemistry Beckman Coulter studies new blood assay to identify BPH By KAREN YOUNG Medical Device Daily Staff Writer ORLANDO - With questions and controversy swirling concerning the efficacy of...

Law firm alleges Guidant device failures closer to 8% than 1%.(Scott+Scott expand litigation against Guidant )
August 1, 2005... Law firm alleges Guidant device failures closer to 8% than 1% By DON LONG Medical Device Daily Managing Editor Scott+Scott (Colchester, Connecticut) continued to expand its litigation against Guidant (Indianapolis) in the wake of...

DNAPrint initiates new campaigns.(Brief Article)
August 1, 2005... DNAPrint initiates new campaigns DNAPrint genomics (Sarasota, Florida) reported a new corporate marketing and product branding campaign focused on the company's four markets - pharmacogenomics and test/drug combinations, forensics...

Deals roundup.(Micrus Endovascular acquired VascularFX)(Renal America plannong to become the fourth-largest provider of outpatient dialysis services)(Bio-Matrix Scientific Group signed long-term lease of a San Diego)(Company Profile)
August 1, 2005... Deals roundup Renal America buying centers; Micrus acquires VascularFX A Medical Device Daily Staff Report Renal America (Brentwood, Tennessee) said it will become the fourth-largest provider of outpatient dialysis services in the...

House bill proposes MMA 'fix' for home medical equipment.
August 1, 2005... House bill proposes MMA 'fix' for home medical equipment By CHRISTOPHER DELPORTE Medical Device Daily Washington Editor WASHINGTON - New legislation being introduced in the U.S. House of Representatives takes aim at durable medical...

Frist breaks with Bush on federal stem-cell funding.
August 1, 2005... Frist breaks with Bush on federal stem-cell funding WASHINGTON - Pleasing Democrats and shocking conservative Republicans, Senate Majority Leader Bill Frist (R-Tennessee) announced on Friday his support for House-passed legislation to...

Financings roundup.(Advanced Research Technologies )(Company Profile)
August 1, 2005... Financings roundup ART raises $5M to support R&D for eXplore Optix and SoftScan A Medical Device Daily Staff Report Advanced Research Technologies (ART; Montreal), a developer of bio-optical imaging systems for the healthcare and...

Court report.
August 1, 2005... Court report Medtronic wins stay in dispute over its multi-axial screws A Medical Device Daily Staff Report In one of the many ongoing litigation sagas in the medical device sector, Medtronic (Minneapolis) last week reported that...

Innocoll, Surgical-IOC team on adhesion barrier.(Innocoll (Ashburn, Virginia) signed development and distribution agreement with Surgical-IOC (France))(Brief Article)
August 1, 2005... Innocoll, Surgical-IOC team on adhesion barrier Innocoll (Ashburn, Virginia) said its wholly owned subsidiary, Innocoll Technologies, has entered into a development and distribution agreement with Surgical-IOC (St. Etienne, France) for the...

People in Places.(IQ Medical appointed Svein Milford and Johnny Christiansen and Robert Rudman)
August 1, 2005... People in Places * Microfluidic technology developer IQ Medical (West Palm Beach, Florida) reported the selection of new officers. Svein Milford is company chairman and Johnny Christiansen is president and CEO. The CFO, secretary and...

Product Briefs.(Dictaphone reported the availability of mdEssential)(Brief Article)
August 1, 2005... Product Briefs * Dictaphone (Stratford, Connecticut) reported the availability of mdEssential, which it said is the industry's first software solution designed to automate the clinical documentation process by combining its voice...

Washington roundup.
August 2, 2005... Washington roundup Expert panel says national HIT network will cost $156 billion By CHRIS DELPORTE Medical Device Daily Washington Editor A panel of healthcare and technology experts said a $156 billion capital investment...

Viking bringing affordable 3-D capability to MIS procedures.(Viking Systems 3-D imaging for minimally invasive surgeries)
August 2, 2005... Viking bringing affordable 3-D capability to MIS procedures By HOLLAND JOHNSON Medical Device Daily Associate Managing Editor While many are familiar with the concept of 3-D imaging, not everyone is aware that the 3-D concept also...

Report from Europe.
August 2, 2005... Report from Europe Medtronic planning 40-country launch of Endeavor DES device A Medical Device Daily Staff Report Medtronic (Minneapolis) reported receiving CE-marking for its Endeavor Drug-Eluting Coronary Stent with the Rapid...

More individualized patient care drives new paths in diagnostics.
August 2, 2005... American Association for Clinical Chemistry More individualized patient care drives new paths in diagnostics By KAREN YOUNG Medical Device Daily Staff Writer ORLANDO - Diagnostics is both growing broader - through new...

Guidant gets relaunch okay for Contak ICD; to offer more info.
August 2, 2005... Guidant gets relaunch okay for Contak ICD; to offer more info A Medical Device Daily Staff Report Though still pummeled by the legal and public relations effects of a rash of recalls for its implantable cardioverter defibrillators...

Plastic surgery panel to meet Aug. 25-26.
August 2, 2005... Plastic surgery panel to meet Aug. 25-26 The General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee will meet Aug. 25-26, 8 a.m.-6 p.m., at the Hilton Washington DC North/Gaithersburg, in Gaithersburg, Maryland....

Financings roundup.
August 2, 2005... Financings roundup Vascular in $50M shelf filing; GE, UVA in development pact A Medical Device Daily Staff Report Vascular Solutions (Minneapolis) reported filing a universal shelf registration statement with the Securities and...

Align in manufacturing consolidation.(Align Technology)(Brief Article)
August 2, 2005... Align in manufacturing consolidation Align Technology (Santa Clara, California), developer of Invisalign, a method of straightening teeth without wires and brackets, said it will consolidate some of its manufacturing process in Juarez,...

Court report.
August 2, 2005... Court report HealthSouth to pay $7 million of $25 million to settle lawsuit A Medical Device Daily Staff Report Following the not guilty verdicts delivered for its founder and former CEO Richard Scrushy, aftershocks keep coming for...

ADA develops new association to address obesity in America.
August 2, 2005... ADA develops new association to address obesity in America A Medical Device Daily Staff Report The American Diabetes Association (ADA; Alexandria, Virginia) reported the creation of "Shaping America's Health: Association for Weight...

Deals roundup.(Qiagen acquired LumiCyte Inc. and SuNyx)(Company Profile)
August 2, 2005... Deals roundup Qiagen buy of LCI, SuNyx adds assets for sample preparation A Medical Device Daily Staff Report Qiagen (Venlo, The Netherlands) reported that it has agreed to acquire key assets of LumiCyte (LCI: Fremont, California)...

Product Briefs.
August 2, 2005... Product Briefs * Endologix (Irvine, California) said it received FDA approval to enroll patients in its clinical trial using its Powerlink System to treat abdominal aortic aneurysm (AAA) in patients with large diameter aortic necks. If...

People in Places.(Osteotech has named Mark Burroughs)(Thomas Dugan and Robert Massa named vice presidents at SonoSite)(James Smith named vice president and chief operating officer of Suros Surgical Systems)(Joseph Cooper named senior manager, radiology CT, for Toshiba America Medical Systems)
August 2, 2005... People in Places * Osteotech (Eatontown, New Jersey) has named Mark Burroughs, Osteotech's vice president, finance, and treasurer, to succeed Michael Jeffries as executive vice president, CFO and secretary. Jeffries last week announced his...

AtriCure seeking $45.6 million, Electro-Optical $29M in IPOs.(Inverness Medical Innovations sells common shares)
August 3, 2005... AtriCure seeking $45.6 million, Electro-Optical $29M in IPOs A Medical Device Daily Staff Report The initial public offering (IPO) market appeared to heat up this week, with two of several offerings being made by medical device...

Babies, children target niche for tee-sized PediPump VAD.(ventricular assist devices)
August 3, 2005... Babies, children target niche for tee-sized PediPump VAD By KIM URQUHART Medical Device Daily Staff Writer Ventricular assist devices (VADs) have revolutionized the treatment of cardiac disease in adults, improving survival for...

Report from Europe.
August 3, 2005... Report from Europe Biosite in European launch of its rapid Triage Stroke Panel A Medical Device Daily Staff Report Biosite (San Diego) reported commercialization of its Triage Stroke Panel, a rapid immunoassay used to aid in the...

Washington roundup.
August 3, 2005... Washington roundup CMS pay will push quality data; new rules for DRG cardio care By CHRISTOPHER DELPORTE Medical Device Daily Washington Editor WASHINGTON - Congress may have hightailed it out of town for its month-long summer...

FDA reports voluntary recall of Disetronic pump adapters.(D-Tron adapters)(warning on metallic tracheal stents)
August 3, 2005... FDA reports voluntary recall of Disetronic pump adapters A Medical Device Daily Staff Report The FDA said that Disetronic Medical Systems (Fishers, Indiana) has issued a voluntary nationwide recall of its D-Tron adapters, used with the...

Deals roundup.
August 3, 2005... Deals roundup HealthTronics spins off ESWL tech to SanuWave for $10.4M A Medical Device Daily Staff Report HealthTronics (Austin, Texas) reported the sale of its orthopedic electrocorporeal shockwave lithotripsy (ESWL) assets to...

Financings roundup.
August 3, 2005... Financings roundup Innovative Spine Tech raises $39 million in Series B round A Medical Device Daily Staff Report Innovative Spinal Technologies (IST; Boston), a private company focused on developing minimally invasive systems for...

MBF will focus equity fund of $200M on U.S. health services.(MBF Healthcare Partners)(Brief Article)
August 3, 2005... MBF will focus equity fund of $200M on U.S. health services A Medical Device Daily Staff Report Private equity firm MBF Healthcare Partners (MBF; Coral Gables, Florida) has been established by Miguel Fernandez, with $200 million in...

Briefly Noted.
August 3, 2005... Briefly Noted Siemens, Xilinx in collaboration Xilinx (San Jose, California), a supplier of programmable logic, and Siemens Medical Solutions (Malvern, Pennsylvania), entered a collaboration that is expected to result in what the...

People in Places.
August 3, 2005... People in Places * Timothy Holzer, PhD, has been appointed to head the R&D program of DiagnoCure (Quebec City, Quebec). In addition to leading various industrial R&D management functions, Holzer has served as director, technology and...

Grants/contracts.
August 3, 2005... Grants/contracts Nanogen gets $2.5M grant for CAP; Arrow, Novation In pact A Medical Device Daily Staff Report Nanogen (San Diego), a developer of advanced diagnostics, reported that the National Institute of Allergy and Infectious...

Product Briefs.
August 3, 2005... Product Briefs * Source Medical Solutions (Birmingham, Alabama), a provider of outpatient information management solutions, reported the availability of the SourcePlus EHR powered by Cyramed, a wireless electronic health records (EHR)...

Newborn screening technology thorough, but raises questions.
August 4, 2005... First of two stories Newborn screening technology thorough, but raises questions By CHRISTOPHER DELPORTE Medical Device Daily Washington Editor WASHINGTON - Newborn screening for genetic diseases has been around since...

Biomet molds are cleared for use in knee revision surgery.
August 4, 2005... Biomet molds are cleared for use in knee revision surgery By HOLLAND JOHNSON Medical Device Daily Associate Managing Editor After a decade-long delay, Biomet (Warsaw, Indiana) reported that the FDA has granted marketing clearance...

Report from Europe.
August 4, 2005... Report from Europe Elekta's IGRT technology is featured at physicists event A Medical Device Daily Staff Report Elekta (Stockholm, Sweden) said that more than 25 papers based upon clinical experience using its technology in the...

Nasdaq debuts new offering: a broader healthcare index.(Nasdaq Healthcare Index)
August 4, 2005... Nasdaq debuts new offering: a broader healthcare index By AARON LORENZO Medical Device Daily Staff Writer Concurrent with launching a new indexing platform, the Nasdaq Stock Market also introduced a new index, the Nasdaq Healthcare...

MannKind raises $175M for inhaled insulin system work.(Urologix signs research agreement with ProUroCare Medical and Rensselaer Polytechnic Institute to develop ProUroVision)
August 4, 2005... MannKind raises $175M for inhaled insulin system work By AARON LORENZO Medical Device Daily Staff Writer MannKind (Valencia, California) is raising $175 million through a private stock-and-warrant sale, with its top executive...

Deals roundup.
August 4, 2005... Deals roundup Cantel gets Crosstex for $74M; RehabCare finishes asset buy A Medical Device Daily Staff Report Cantel Medical (Little Falls, New Jersey), said that as part of its plan to expand its infection prevention and control...

Court report.
August 4, 2005... Court report Carolina Liquid denies charges in complaint by Clinical Data A Medical Device Daily Staff Report Carolina Liquid Chemistries (Brea, California), a clinical diagnostic company, promised a "vigorous" defense against...

Financings roundup.
August 4, 2005... Financings roundup Ortho-Clinical granted assay license by Competitive Tech A Medical Device Daily Staff Report Competitive Technologies (CTT; Fairfield, Connecticut) reported that it has granted an assay license to Ortho-Clinical...

Medical device firms given small weights in new index.(Nasdaq Healthcare Index)(Brief Article)
August 4, 2005... Medical device firms given small weights in new index A Medical Device Daily Staff Report Of the 542 companies in the new Nasdaq Healthcare Index - as listed in a spreadsheet provided to Medical Device Daily on Wednesday - firms in the...

States vary widely on tests for screening of newborns.
August 4, 2005... States vary widely on tests for screening of newborns By CHRISTOPHER DELPORTE Medical Device Daily Washington Editor Though expanded newborn screening is required by law in many states, most babies still are not covered by the full...

Product briefs.
August 4, 2005... Product briefs * Bellacure (Seattle), which specializes in the treatment of arthritis, reported the release of a new patent-pending device shown in preliminary studies to offer significant pain relief without the use of surgery or drugs....

People in Places.
August 4, 2005... People in Places * Marlene McCurdy has joined Medsphere Systems (Aliso Viejo, California) as vice president of client services. McCurdy joins Medsphere after serving as vice president of client services for IDX Systems. Medsphere is a...

Brain monitoring may - or may not - get boost from ASA report.(American Society of Anesthesiologists)
August 5, 2005... First of two stories Brain monitoring may - or may not - get boost from ASA report By DON LONG Medical Device Daily Managing Editor A recent report by the American Society of Anesthesiologists (ASA; Parkridge, Illinois) may -...

Advocates, agencies eye state parity in testing of newborns.
August 5, 2005... Second of two stories Advocates, agencies eye state parity in testing of newborns By CHRISTOPHER DELPORTE Medical Device Daily Washington Editor WASHINGTON - "Some of these conditions may be rare, but if it's your little boy...

Report from Israel.
August 5, 2005... Report from Israel Philips seen lighting upon the acquisition of Lumenis By RAE FISHMAN Medical Device Daily Correspondent ZICHRON YAAKOV, Israel - The Israeli press and capital markets are lit up with reports that Royal...

Tengion gets Series A $39M for work in autologous cells.(Infrared Sciences completes financing)
August 5, 2005... Tengion gets Series A $39M for work in autologous cells By AARON LORENZO Medical Device Daily Staff Writer and Staff Reports Tengion (King of Prussia, Pennsylvania) raised $39 million in its first private financing round for...

Deals roundup.
August 5, 2005... Deals roundup Fisher buys McKesson unit, agrees to acquire Cellomics A Medical Device Daily Staff Report Fisher Scientific International (Hampton, New Hampshire) said it has completed its $60 million acquisition of McKesson...

Financings roundup.
August 5, 2005... Financings roundup Biophan confirms receipt of $5.75 million from Boston Sci A Medical Device Daily Staff Report Biophan Technologies (West Henrietta, New York) confirmed the receipt of $5.75 million in investments and licensing...

Briefly Noted.
August 5, 2005... Briefly Noted DCLs to be regulated as devices Before leaving Washington for its August recess, the Senate passed a bill by unanimous consent to require the FDA to regulate decorative contact lenses (DCLs) as a medical device, similar...

Grants/contracts.
August 5, 2005... Grants/contracts ImaRX receives $1.1M grant; NHLBI grant goes to BioPAL A Medical Device Daily Staff Report ImaRx Therapeutics (Tucson, Arizona) reported that is has received a $1.1 million Phase II Small Business Innovation...

ACC to hold imaging conference.(American College of Cardiology)(Brief Article)
August 5, 2005... ACC to hold imaging conference Imaging has become a heated topic, embroiling cardiologists and more than 20 other medical specialists in a debate about tests selected and who performs and interprets them. In San Francisco on Aug....

With education, screening avoids retardation, saves lives.(Brief Article)
August 5, 2005... With education, screening avoids retardation, saves lives Current newborn screening in the U.S. identifies metabolic and endocrine disorders via genetic screening in roughly 5,000 babies each year. If all states adopted standard screening,...

Product Briefs.
August 5, 2005... Product Briefs * Bruker AXS (Madison, Wisconsin), a unit of Bruker BioSciences providing advanced X-ray solutions for life and advanced materials sciences, launched its new LynxEye detector at the 2005 Denver X-ray Conference for higher...

Washington roundup.
August 8, 2005... Washington roundup CMS issues new guidelines on non-HIPAA-compliant claims By CHRISTOPHER DELPORTE Medical Device Daily Washington Editor WASHINGTON - The Centers for Medicare & Medicaid Services (CMS; Baltimore) said it would...

Brain monitors for a problem infrequent and hard to define.(Aspect Medical System's Bispectral index)
August 8, 2005... Second of two stories Brain monitors for a problem infrequent and hard to define By DON LONG Medical Device Daily Managing Editor and KAREN YOUNG Medical Device Daily Staff Writer Aspect Medical Systems (Newton,...

NuVasive acquires nucleus-like replacement device from UK.
August 8, 2005... NuVasive acquires nucleus-like replacement device from UK By HOLLAND JOHNSON Medical Device Daily Associate Managing Editor NuVasive (San Diego), a medical device company focused on developing products for minimally disruptive...

Report from Europe.
August 8, 2005... Report from Europe Bowel-cancer screening plan to start in UK in April 2006 A Medical Device Daily Staff Report The UK's National Health Service (NHS) will initiate a national bowel cancer screening program in England, beginning in...

Brain signals lead researchers on path to neural prosthetics.
August 8, 2005... Brain signals lead researchers on path to neural prosthetics By DAVID KOSUB Medical Device Daily Contributing Writer A team of American researchers and an Israeli scientist have developed a prosthetic that could take them one step...

In wake of graft occlusions, CABG halts its clinical trials.(CABG Medical's Holly Graft System)
August 8, 2005... In wake of graft occlusions, CABG halts its clinical trials By HOLLAND JOHNSON Medical Device Daily Associate Managing Editor CABG Medical (Minneapolis), developer of the Holly Graft, a drug-eluting graft for coronary artery bypass...

Deals roundup.
August 8, 2005... Deals roundup Philips completes Stentor buy; PolyMedica gets NDP for $55M A Medical Device Daily Staff Report Philips Medical Systems (Andover, Massachusetts), a division of Royal Philips Electronics (Amsterdam, the Netherlands),...

Financings roundup.
August 8, 2005... Financings roundup AtriCure sets IPO price to gain $48M, over-allotments $49.8M A Medical Device Daily Staff Report AtriCure (West Chester, Ohio) reported the pricing of its initial public offering of 4 million shares of common...

Grants/contracts.
August 8, 2005... Grants/contracts Innovative Bio wins SBIR grant for development of BSE test A Medical Device Daily Staff Report Innovative Biosensors (IBI; College Park, Maryland), a company developing tests to detect pathogens, reported receiving...

Briefly Noted.
August 8, 2005... Briefly Noted Conceptus, Gynecare terminate agreement Conceptus (San Carlos, California), developer of the Essure permanent birth control system, on Friday reported that that Conceptus and Gynecare Worldwide (Somerville, New Jersey), a...

People in Places.
August 8, 2005... People in Places * Derek Smith has been named president of the new Hospital Group of Respironics (Murrysville, Pennsylvania). Most recently, he served as senior vice president of operations and technology development for McKesson Health...

Product Briefs.
August 8, 2005... Product Briefs * Corautus Genetics (Atlanta) reported that an independent data monitoring committee (DMC) recommended, in its second interim safety analysis, the continuation of Genetic Angiogenic Stimulation Investigational Study...

Stryker's Brown named to new seat on St. Jude Medical board.(John Brown)(Brief Article)
August 8, 2005... Stryker's Brown named to new seat on St. Jude Medical board A Medical Device Daily Staff Report St. Jude Medical (St. Paul, Minnesota) on Friday reported that it has named John Brown, chairman of Stryker (Kalamazoo, Michigan) to a...

Deals roundup.
August 9, 2005... Deals roundup Quest Diagnostics to acquire LabOne in $934M transaction By HOLLAND JOHNSON Medical Device Daily Associate Managing Editor Diagnostic testing giant Quest Diagnostics (Lyndhurst, New Jersey) reported that it has...

FDA approval marks St. Jude stented tissue valve entry.(SJM Biocor and Biocor Supra stents)
August 9, 2005... FDA approval marks St. Jude stented tissue valve entry By KAREN YOUNG Medical Device Daily Staff Writer St. Jude Medical (St. Paul, Minnesota) has received FDA approval for the SJM Biocor and Biocor Supra family of stented tissue...

Report from Europe.
August 9, 2005... Report from Europe Grant to speed development of bone-healing technology A Medical Device Daily Staff Report Inion (Tampere, Finland), a company focused on the development of biodegradable medical implants, has secured a grant of...

Washington roundup.
August 9, 2005... Washington roundup OIG report scrutinizes NIH staffers' conflicts of interest By CHRISTOPHER DELPORTE Medical Device Daily Washington Editor WASHINGTON - According to a recent report released by the inspector general of the...

Financings roundup.
August 9, 2005... Financings roundup LSB in $15M equity accord; RITA Medical to get $9.7M A Medical Device Daily Staff Report Large Scale Biology (LSB; Vacaville, California) entered into a three-year private equity agreement with a Southridge...

Commentary: Belief-based opposition to stem-cell research an absurdity.
August 9, 2005... Commentary: Belief-based opposition to stem-cell research an absurdity By DAVID HOLCBERG and ALEX EPSTEIN It is widely known that embryonic stem cell research has the potential to revolutionize medicine and save millions of lives....

Court report.
August 9, 2005... Court report FDA denies newspaper's bid for key data on Guidant ICDs A Medical Device Daily Staff Report The New York Times reported in Saturday's edition that a Freedom of Information Act request made by the newspaper to the FDA...

Briefly Noted.
August 9, 2005... Briefly Noted CMS expands VAD reimbursement Abiomed (Danvers, Massachusetts) reported that the Centers for Medicare & Medicaid Services (CMS; Baltimore) has increased reimbursement for external ventricular assist devices (VADs) with...

Product Briefs.
August 9, 2005... Product Briefs * DePuy Spine (Raynham, Massachusetts) said that safety and efficacy data from the clinical trial that led to the approval of the Charite artificial disc by the FDA were published in the July 15th issue of Spine. The...