Medical Device Week articles from October 2006

Medical Device Week archives from October 2006

Washington roundup.
October 2, 2006... Washington roundup Aggressive march of lab coats on Hill may have desired effect By MARK McCARTY Medical Device Daily Washington Editor Physicians who render services for fees under Medicare Part B have been up in arms for...

'Promising' aphasia study data, Northstar Neuroscience says.
October 2, 2006... 'Promising' aphasia study data, Northstar Neuroscience says By KAREN YOUNG Medical Device Daily Staff Writer Northstar Neuroscience (Seattle) last week reported what it called "promising" initial data from an eight-patient...

International report.
October 2, 2006... International report Calypte granted approval in Russia for HIV-1/2 rapid test A Medical Device Daily Staff Report Calypte Biomedical (Lake Oswego, Oregon) reported receiving approval for its Aware Oral Fluid (OMT) HIV-1/2 rapid...

Financings roundup.
October 2, 2006... Financings roundup CoAxia adds 'C' $11 million for support of NeuroFlo progress A Medical Device Daily Staff Report CoAxia (Maple Grove, Minnesota) reported that its SENTIS (Safety and Efficacy of NeuroFlo Treatment for Ischemic...

Deals roundup.
October 2, 2006... Deals roundup Cytyc plans to hike offer in bidding war for Vision Systems A Medical Device Daily Staff Report Based on the bidding war it has generated, Vision Systems (Melbourne, Australia) appears to be a very hot property. And...

FDA, industry say they like HRS' new guidelines for CRM.
October 2, 2006... FDA, industry say they like HRS' new guidelines for CRM A Medical Device Daily Staff Report In response to the list of recommendations for reporting malfunctions and adverse events for cardiac rhythm management (CRM) devices unveiled...

Briefly Noted.
October 2, 2006... Briefly Noted Unique Device Identification meeting set The FDA has scheduled a public meeting and vendor display to discuss the issues associated with the development, implementation and use of a unique device identification system and...

Medtronic gets FDA warning for AneuRX postmarket filing delay.
October 2, 2006... Medtronic gets FDA warning for AneuRX postmarket filing delay A Medical Device Daily Staff Report Medtronic (Minneapolis) Friday reported receiving an FDA warning letter regarding the delayed filing of a postmarket surveillance...

Product Briefs.
October 2, 2006... Product Briefs * Vasomedical (Westbury, New York) reported that three presentations were given highlighting the benefits of external counterpulsation (EECP) therapy in patients with heart failure at the 10th annual Heart Failure Society of...

People in Places.
October 2, 2006... People in Places * Hercules Technology Growth Capital (Palo Alto, California) reported the promotions of Samir Bhaumik and Parag Shah. Bhaumik was promoted to senior managing director and head of Hercules' technology group in the Palo Alto...

MRI expert Koretsky to lead research programs at NINDS.
October 2, 2006... MRI expert Koretsky to lead research programs at NINDS A Medical Device Daily Staff Report The National Institute of Neurological Disorders and Stroke (NINDS), a part of the National Institutes of Health, has appointed Alan Koretsky,...

HAPC in $140M InfuSystem buy; O&M closes McKesson unit buy.
October 3, 2006... HAPC in $140M InfuSystem buy; O&M closes McKesson unit buy A Medical Device Daily Staff Report HAPC (New York) reported that it has entered into an agreement to acquire InfuSystem (Madison Heights, Michigan), a subsidiary of I-Flow...

Washington roundup.
October 3, 2006... Washington roundup Legal 'rebukes' spur on CMS to publish wage indices for IPPS By MARK McCARTY Medical Device Daily Washington Editor WASHINGTON -- Asking a government agency to engage in statistical analyses might seem to...

Report from Europe.
October 3, 2006... Report from Europe Genzyme wins expanded OK for Synvisc in ankle, shoulder OA A Medical Device Daily Staff Report Genzyme (Cambridge, Massachusetts) reported that it has received approval to expand the CE-mark labeling for Synvisc...

Boston Sci wins FDA approval for Harmony Bionic Ear System.
October 3, 2006... Boston Sci wins FDA approval for Harmony Bionic Ear System By KAREN YOUNG Medical Device Daily Staff Writer Hearing aids are among the least satisfying of technologies for consumers in the medical device sector. They don't work...

IOM report: Drug safety issues point to FDA fund imbalance.
October 3, 2006... IOM report: Drug safety issues point to FDA fund 'imbalance' By AARON LORENZO Medical Device Daily Staff Writer WASHINGTON -- More than a week after the Institute of Medicine (IOM) issued its wide-ranging criticism of the FDA's...

Clarification.(Correction notice)
October 3, 2006... Clarification Medical Device Daily was incorrect in stating in Monday's issue ('Promising aphasia study data, Northstar Neuroscience says'; MDD, Oct. 2, 2006) that Northstar Neuroscience (Seattle) in August reported successful preliminary...

Agreements roundup.
October 3, 2006... Agreements roundup Abbott to provide monitoring supplies to BD diabetic patients A Medical Device Daily Staff Report Abbott (Alameda, California) reported that it will provide a free Abbott blood glucose meter and a starter supply...

Financings roundup.
October 3, 2006... Financings roundup Lusora Healthcare raises private $700,000 in 2 placements A Medical Device Daily Staff Report Lusora Healthcare Systems (San Francisco), a wireless personal and home health security company, reported closing two...

<i>MDD</I> releases new report on orthopedics market.
October 3, 2006... MDD releases new report on orthopedics market The publishers of Medical Device Daily have just released a new 200-page report focusing on the orthopedics sector, Orthopedics 2006 -- Trends, Challenges and Opportunities. The report provides...

Deals roundup.
October 3, 2006... Deals roundup Continucare closes cash/stock buy of MDHC and its affiliates A Medical Device Daily Staff Report Continucare (Miami) reported completing its previously disclosed purchase of Miami Dade Health Centers (MDHC) and its...

Grants/contracts news.
October 3, 2006... Grants/contracts news Pittsburgh researchers awarded $12.8M for lung disease diagnosis A Medical Device Daily Staff Report Researchers at Children's Hospital of Pittsburgh of University of Pittsburgh Medical Center and University...

Product Briefs.
October 3, 2006... Product Briefs * Apogee Technology (Norwood, Massachusetts) reported that it has filed five U.S. provisional patent applications related to its PyraDerm intradermal drug delivery system. Three of the new patent applications pursue the...

People in Places.
October 3, 2006... People in Places * Brigid Makes has been appointed CFO of AGA Medical (Golden Valley Minnesota). Most recently, Makes was an executive with Nektar Therapeutics. AGA develops devices to treat structural heart defects. * Gemma Rosello...

Deals roundup.(Company overview)
October 4, 2006... Deals roundup Baxter spins tranfusion unit to Texas Pacific for $540M By DON LONG Medical Device Daily Managing Editor Baxter International (Deerfield, Illinois) yesterday reported that it has entered an agreement to sell...

Abbott scuttles ZoMaxx work, launches Xience V DES in Europe.
October 4, 2006... Abbott scuttles ZoMaxx work, launches Xience V DES in Europe By HOLLAND JOHNSON Medical Device Daily Associate Managing Editor In a move that the company said is based primarily on clinical data, Abbott Laboratories (Abbott Park,...

Report from Europe.
October 4, 2006... Report from Europe TransMedics granted CE mark for organ donor care system A Medical Device Daily Staff Report TransMedics (Andover, Massachusetts) reported receiving CE marking for its Organ Care System, which it calls "the first...

Light Sciences in 5.25M share IPO; Medserve gathers in $50 million.
October 4, 2006... Light Sciences in 5.25M share IPO; Medserve gathers in $50 million By DON LONG Medical Device Daily Managing Editor Light Sciences Oncology (LSO; Snoqualmie, Washington), a developer of light infusion cancer therapy, is preparing...

Court report.
October 4, 2006... Court report CryoLife reports settlement of dispute via $2.25M payment A Medical Device Daily Staff Report Biomedical and biosurgical devices company CryoLife (Kennesaw, Georgia), reported settling an outstanding insurance coverage...

Grants/contracts.
October 4, 2006... Grants/contracts Isis receives government order for Ibis T5000 Biosensor system A Medical Device Daily Staff Report Isis Pharmaceuticals (Carlsbad, California) reported that it has received its first commercial order for Ibis T5000...

Agreements.
October 4, 2006... Agreements Claricode develops medication 'orb' device for adherence study A Medical Device Daily Staff Report Claricode (Waltham, Massachusetts), a provider of software development and application integration services for...

Financings roundup.
October 4, 2006... Financings roundup Over-allotment purchase after Home Diag IPO totals $90M A Medical Device Daily Staff Report Home Diagnostics (Fort Lauderdale, Florida), a maker of diabetes testing supplies, reported that JPMorgan, the...

Product Briefs.
October 4, 2006... Product Briefs * MediTract (Chattanooga, Tennessee) reported the release of software upgrades for the company's TractManager solution. The new enhancements will deliver an increased level of functionality and flexibility to MediTract's...

People in Places.
October 4, 2006... People in Places * Steven Frankel has been named CEO and a board member of Accumetrics (San Diego). Robert Hillman, company co-founder, will assume the role of chairman. Most recently, Frankel was president of Acon Laboratories....

Rex reports first implantation of Its Option vena cava filter.
October 4, 2006... Rex reports first implantation of Its Option vena cava filter A Medical Device Daily Staff Report Rex Medical (Conshohocken, Pennsylvania) reported implantation of its Option Retrievable Vena Cava Filter in an international clinical...

Cytyc ups its bid for Vision, Ventana 'exploring options'.
October 5, 2006... Cytyc ups its bid for Vision, Ventana 'exploring options' By HOLLAND JOHNSON Medical Device Associate Managing Editor In a move that it had promised to make last week, Cytyc (Marlbourough, Massachusetts) formally raised its offer...

Financings roundup.
October 5, 2006... Financings roundup Lumenis adds $120M investment; Diomed receives private $10M A Medical Device Daily Staff Report Lumenis (Yokneam, Israel), a manufacturer of laser, light- and radiofrequency-based devices for medical, aesthetic,...

Report from Europe.
October 5, 2006... Report from Europe Roslin Institute forms facility for producing stem cell lines By NUALA MORAN Medical Device Daily Contributing Writer LONDON &ndash; The Roslin Institute (Midlothian, Scotland) is setting up a facility to...

Georgia Life Sciences Summit 2006.
October 5, 2006... Georgia Life Sciences Summit 2006 Technology convergence to be key health driver, says Hawkins By KAREN YOUNG Medical Device Daily Staff Writer ATLANTA &ndash; Convergence. It's a word that for years has been used to describe...

Court report.
October 5, 2006... Court report S&N reports winning injunction vs. Synthes for orthopedic nails A Medical Device Daily Staff Report Smith & Nephew (S&N; Memphis, Tennessee) reported that the Federal District Court for the Western District of...

Deals roundup.(A-vox Systems)(Ithaka Aquisition Corporation)
October 5, 2006... Deals roundup Thoratec's ITC division to buy A-vox Systems for $9M cash A Medical Device Daily Staff Report Thoratec (Pleasanton, California), a maker of products to treat cardiovascular disease, said that its International...

Agreements.
October 5, 2006... Agreements MedCath and Benefis terminate cardiovascular service alliance A Medical Device Daily Staff Report MedCath (Charlotte, North Carolina) and Benefis Healthcare (Great Falls, Montana) reported that they will end their...

Quest beaten by LabCorps for UnitedHealthCare business.
October 5, 2006... Quest beaten by LabCorps for UnitedHealthCare business A Medical Device Daily Staff Report Quest Diagnostics (Lyndhurst, New Jersey), the major provider of diagnostic testing services in the U.S., has disclosed that it has lost its...

Grants/contracts.
October 5, 2006... Grants/contracts SBIR funding will support R&D of Pressure Bio's cycling tech A Medical Device Daily Staff Report Pressure BioSciences (West Bridgewater, Massachusetts) reported receiving a Phase I Small Business Innovation...

CytoCore hires SIPR for InPath campaign.(Millipore Corp. opens new research and development center)(Brief article)
October 5, 2006... CytoCore hires SIPR for InPath campaign CytoCore (Chicago) reported that it has engaged the public relations firm, SIPR (San Francisco), to launch a campaign for its InPath system, an early detection test for uterine/endometrial cancers....

Briefly Noted.
October 5, 2006... Briefly Noted Obesity Congress set for October The Cleveland Clinic Bariatric and Metabolic Institute (Cleveland) will host a national meeting on obesity Oct. 12-14, to explore potential solutions to the emerging obesity epidemic. The...

Product Briefs.(Medafor, Inc.)(Omni-Tract Surgical)(Brief article)
October 5, 2006... Product Briefs &bull; Medafor (Minneapolis) reported that its Arista AH Absorbable Hemostat has received FDA approval to be marketed in the U.S. This hemostat is indicated for most types of surgery including cardiac, orthopedic, spinal and...

People in Places.(Mar Cor Purification)(David Elizondo)(Curtis Weitnauer)(Stephen Crawford)(Brief article)
October 5, 2006... People in Places &bull; David Elizondo has been named vice president, research and development, for ATS Medical (Minneapolis). Previously, Elizondo was director, new business development, at Boston Scientific. ATS makes products focused on...

Studies say Cypher outperforms Taxus in small-vessel study.
October 5, 2006... Studies say Cypher outperforms Taxus in small-vessel study A Medical Device Daily Staff Report Cordis (Miami Lakes, Florida) reported that two independent studies published this week in the Journal of the American College of Cardiology...

Holiday notice.
October 6, 2006... Holiday notice Medical Device Daily's offices will be closed on Monday, Oct. 9, in observance of the Columbus Day holiday in the U.S., and no issue will be published. The next issue of MDD will be published on Tuesday, Oct. 10....

FDA roundup.
October 6, 2006... FDA roundup No congressional input needed for FDA to eliminate 'R word' By MARK McCARTY Medical Device Daily Washington Editor WASHINGTON -- Thanks to a tremendous amount of confusion over the meaning and implications of the...

Deals roundup.
October 6, 2006... Deals roundup 'Positive developments' in bid for Vision Systems cited by Cytyc By HOLLAND JOHNSON Medical Device Daily Associate Managing Editor In the ongoing saga chronicling the battle to acquire Vision Systems (Melbourne,...

Report from Europe.
October 6, 2006... Report from Europe Medtronic wins CE mark for new transcatheter valve technology By HOLLAND JOHNSON Medical Device Daily Associate Managing Editor Signaling what it said is a "new frontier in the use of transcatheter valve...

Conor gets extended shelf life OK.
October 6, 2006... Conor gets extended shelf life OK Conor Medsystems (Menlo Park, California), a developer of vascular drug delivery technologies, reported receiving regulatory approval for extending the shelf life of Conor's CoStar cobalt chromium...

'Shaping Infinity' report shows state's life science on the move.
October 6, 2006... Georgia Life Sciences Summit 2006 'Shaping Infinity' report shows state's life science on the move By KAREN YOUNG Medical Device Daily Staff Writer ATLANTA -- Biomedical research and medical device development have become the...

Court report.
October 6, 2006... Court report Chembio, Statsure end dispute, enter agreements with Inverness A Medical Device Daily Staff Report Chembio Diagnostics (Medford, New York) and StatSure Diagnostic Systems (SDS; Framingham, Massachusetts) reported...

Financings roundup.
October 6, 2006... Financings roundup Chembio gathers private $8.5M; PHNS in $150M refinancing A Medical Device Daily Staff Report Chembio Diagnostics (Medford, New York) reported receiving private funding of $8.15 million of Series C 7% convertible...

Briefly Noted.
October 6, 2006... Briefly Noted Allergan creates new Medical division Allergan (Irvine, California) reported completing the integration of the operations of Inamed, uniting the companies' facial aesthetics, breast aesthetics and obesity intervention...

Agreements.
October 6, 2006... Agreements Inverness, Chembio, StatSure form HIV testing alliance A Medical Device Daily Staff Report Inverness Medical Innovations (Waltham, Massachusetts), Chembio Diagnostics (Medford, New York) and StatSure Diagnostic Systems...

Insurer pays most for heart attacks.
October 6, 2006... Insurer pays most for heart attacks Heart attacks are by far the top reason for claims on Colonial Life & Accident Insurance (Columbia, South Carolina) critical illness policies, the company reported. Of all the critical illness claims...

Hill-Rom to make manufacturing moves, 'right-sizes' employees.
October 6, 2006... Hill-Rom to make manufacturing moves, 'right-sizes' employees A Medical Device Daily Staff Report Hillenbrand Industries (Batesville, Indiana) this week reported a variety of initiatives involving potential manufacturing moves and...

Product Briefs.
October 6, 2006... Product Briefs * Aperio Technologies (Vista, California) has received patent No. 7,116,440 entitled "Image Processing and Analysis Framework" from the U.S. Patent and Trademark Office. "We have steadily extended our patent portfolio from...

Aksys reports 'on time' delivery of next-generation prototype.
October 6, 2006... Aksys reports 'on time' delivery of next-generation prototype A Medical Device Daily Staff Report Aksys (Lincolnshire, Illinois), a developer of home use dialysis equipment, reported on-time delivery of what it calls "the first...

People in Places.(biotechnology industries appointments)(Brief article)
October 6, 2006... People in Places * Dan Maye has been named vice president, donor services, and Robert Brook has become vice president, operations of AlloSource (Centennial, Colorado). Both men held previous positions at AlloSource before taking over their...

Report identifies large need to improve FDA 'nano-readiness'.
October 10, 2006... Report identifies large need to improve FDA 'nano-readiness' By DON LONG Medical Device Daily Managing Editor The science of very, very small things that can be used in healthcare products has a big problem. Such is the...

SGR is lacking fans, but reports of demise greatly exaggerated.
October 10, 2006... SGR is lacking fans, but reports of demise greatly exaggerated By MARK McCARTY Medical Device Daily Washington Editor WASHINGTON -- The Medicare Payment Advisory Commission (MedPAC) met again last week to do further work on the...

International report.
October 10, 2006... International report MDS to sell diagnostic lab unit to Borealis for C $1325 billion A Medical Device Daily Staff Report MDS (Toronto) reported signing an agreement to sell its Canadian laboratory services business, MDS Diagnostic...

Deals roundup.(Company overview)
October 10, 2006... Deals roundup Microtek Medical buy of Europlak enhances European holdings A Medical Device Daily Staff Report Microtek Medical Holdings (Alpharetta, Georgia), a manufacturer of infection control, fluid control and safety products...

Court report.
October 10, 2006... Court report AMR pays $9 million to resolve False Claims Act allegations A Medical Device Daily Staff Report The U.S. Department of Justice (DOJ) reported that American Medical Response (AMR; Greenwood Colorado), one of the...

Financings roundup.
October 10, 2006... Financings roundup Nighthawk shareholders file for public offering of 5 million shares A Medical Device Daily Staff Report NightHawk Radiology Holdings (Couer D'alene, Idaho) reported that it has filed a registration statement with...

Being private seen benefiting partnering and exit strategy.
October 10, 2006... Georgia Life Sciences Summit 2006 Being private seen benefiting partnering and exit strategy By AMANDA LYLE Medical Device Daily Staff Writer ATLANTA -- Attendees of the Georgia Life Sciences Summit here escaped from the early...

$3.8M awarded for informatics neuroimaging clearinghouse.
October 10, 2006... 3NIH roundup $3.8M awarded for informatics neuroimaging clearinghouse A Medical Device Daily Staff Report The National Institutes of Health (NIH) last week reported that it has awarded a five-year, $3.8 million contract under the...

Agreements.
October 10, 2006... Agreements Lumera, systems biology group form pact on cancer biomarkers A Medical Device Daily Staff Report Lumera (Bothell, Washington), a provider of light-applied nanotechnology, reported an expanded collaboration with the...

Briefly Noted.
October 10, 2006... Briefly Noted Vitas to exit Phoenix market Chemed (Cincinnati) reported that its subsidiary Vitas Healthcare (Scottsdale, Arizona), a provider of hospice services, is exiting the Phoenix, Arizona market. The program in Phoenix...

Grants/contracts.
October 10, 2006... Grants/contracts Gambro selects software from Camstar for data management A Medical Device Daily Staff Report Camstar (Charlotte, North Carolina) reported that Gambro BCT (Lakewood, Colorado) has selected Camstar's Medical Device...

Despite physician concerns Part B outlays keep on rolling.
October 10, 2006... Despite physician concerns Part B outlays keep on rolling MARK McCARTY Medical Device Daily Washington Editor WASHINGTON -- The Centers for Medicare and Medicaid Services and MedPAC have put a lot of effort into reining in CMS Part...

Product Briefs.
October 10, 2006... Product Briefs * IYIA Technologies (San Marcos, California) reported preliminary results from a clinical trial using IYIA's wound treatment system, O2Misly (O-Mis-ly), a new method to treat slow-healing diabetic foot ulcers. O2Misly...

People in Places.(Harry Stokes joined InforMedix Holdings )(Brief article)
October 10, 2006... People in Places * Harry Stokes was named senior vice president and CFO of InforMedix Holdings (Rockville, Maryland). Most recently, he was CFO for Transnational Automotive Group. InforMedix also announced the resignation of Douglas Watson...

Deals roundup.(Company overview)
October 11, 2006... Deals roundup Danaher forces rivals to fold via higher bid for Vision Systems By HOLLAND JOHNSON Medical Device Daily Staff Report In a move worthy of a high stakes poker tournament, the newest player in the competition to...

Financings roundup.
October 11, 2006... Financings roundup Macroflux spin-out of Alza raises $75M; SHG files for $175M IPO A Medical Device Daily Staff Report Macroflux (Mountain View, California) has raised $75 million in an equity financing to create a new transdermal...

Report from Europe.
October 11, 2006... Report from Europe Pfizer enters vaccine market via acquisition of PowderMed A Medical Device Daily Staff Report Pfizer (New York) has agreed to acquire PowderMed (Oxford, England), a privately held company that has developed a...

Placental stem cell collection Is demonstrated via webcast.
October 11, 2006... Placental stem cell collection Is demonstrated via webcast By CYNTHIA DRAKE Medical Device Daily Contributing Writer MARGATE, Florida -- Cryo-Cell International (Oldsmar, Florida) and Plureon (Winston-Salem, North Carolina)...

Court report.
October 11, 2006... Court report FDA blocks Endotec's continued sale of total joint replacements A Medical Device Daily Staff Report The FDA is seeking a permanent injunction against Endotec (Orlando, Florida) and Michael Pappas, PhD, company...

Lymph node mapping reduces colorectal cancer recurrence.(Clinical report)
October 11, 2006... American College of Surgeons Clinical Conference Lymph node mapping reduces colorectal cancer recurrence A Medical Device Daily Staff Report According to the results of a recently completed multi-institutional clinical trial,...