Medical Device Week articles from June 2006

Medical Device Week archives from June 2006

Cytyc chief knew that ThinPrep test had 'home run' potential.
June 1, 2006... Celebrating 10 years Cytyc chief knew that ThinPrep test had 'home run' potential By KAREN YOUNG Medical Device Daily Staff Writer This past month Cytyc (Marlborough, Massachusetts) celebrated the 10-year anniversary of...

MedicalCV submits 510(k) for Atrilaze system in AF therapy.
June 1, 2006... MedicalCV submits 510(k) for Atrilaze system in AF therapy By HOLLAND JOHNSON Medical Device Daily Associate Managing Editor Continuing its recent surge of activities, MedicalCV (Inver Grove Heights, Minnesota) yesterday reported...

Report from Israel.
June 1, 2006... Report from Israel Biomed 2006 banners devices at the forefront in life sciences By RAE FISHMAN Medical Device Daily Contributing Writer ZICHRON YAAKOV -- It is spring in Israel, and the life sciences are blooming -- with...

Financings roundup.
June 1, 2006... Financings roundup Alphatec moves ahead with IPO; Sequenom raises $33 million A Medical Device Daily Staff Report Alphatec Holdings (Carlsbad, California), a developer of surgical systems used to treat spinal disorders,...

Corautus responds to GENASIS trial halt, plans for more trials.
June 1, 2006... Corautus responds to GENASIS trial halt, plans for more trials A Medical Device Daily Staff Report Biopharmaceutical company Corautus Genetics (Atlanta) said it has responded to the FDA's halt of its GENASIS (Genetic Angiogenic...

Large gaps in '06 data security punch holes in promise of EHR.
June 1, 2006... Large gaps in '06 data security punch holes in promise of EHR By DON LONG Medical Device Daily Managing Editor Whether anyone, or any publication, other than Medial Device Daily, will mark it or not, the year 2006 may well be...

Deals roundup.
June 1, 2006... Deals roundup ABH acquires S&N's Dermagraft, TransCyte wound care products A Medical Device Daily Staff Report Advanced BioHealing (ABH; New York) reported that it has concluded the acquisition of the assets and rights associated...

Merged firm banners itself as 'largest' in medical tourism.
June 1, 2006... Merged firm banners itself as 'largest' in medical tourism A Medical Device Daily Staff Report Two of the nation's biggest competitors in the growing market for sending patients abroad for healthcare reported a merger that they said...

Agreements roundup.
June 1, 2006... Agreements roundup ART software to be employed in new trial based on MADIT II A Medical Device Daily Staff Report Arrhythmia Research Technology (ART; Fitchburg, Massachusetts) reported entering into a research agreement with the...

Briefly Noted.
June 1, 2006... Briefly Noted AMDL said it is in compliance with AMEX AMDL (Tustin, California), developer of tests for the detection of cancer and other diseases, said it has submitted to the American Stock Exchange (AMEX) a plan that brings the...

People in Places.
June 1, 2006... People in Places * Afshin Abedi, PhD, has been appointed vice president of CardioMag Imaging (Schenectady, New York), responsible for the company's clinical and regulatory activities. CardioMag makes cardiac diagnostic devices called...

Product Briefs.
June 1, 2006... Product Briefs * American Bio Medica (Kinderhook, New York), a manufacturer of immunoassay diagnostic test kits, said that the FDA has granted the company 510(k) clearance on its Rapid TOX, a drug screen in a horizontal cassette platform...

Healthcare IT groups link up, hoping for more clout on Hill.
June 2, 2006... Healthcare IT groups link up, hoping for more clout on Hill By MARK McCARTY Medical Device Daily Washington Editor WASHINGTON -- A Google search of the term "society of association executives" yields more than 22 million hits, so...

FDA okays first U.S. study of MIS stent to treat PAD below the knee.
June 2, 2006... FDA okays first U.S. study of MIS stent to treat PAD below the knee By HOLLAND JOHNSON Medical Device Daily Associate Managing Editor The first U.S. multicenter, prospective clinical trial to investigate the use of minimally...

Report from Europe.
June 2, 2006... Report from Europe BioE, UK university in accord on blood stem cell research A Medical Device Daily Staff Report BioE (St. Paul, Minnesota), which provides human cord blood stem cells for use as cellular tools for drug discovery...

Financings roundup.
June 2, 2006... Financings roundup Asuragen launch receives $49M boost via A-round of financing A Medical Device Daily Staff Report Asuragen (Austin, Texas), an oncology molecular diagnostic company and molecular biology service provider, reported...

Grants/contracts.
June 2, 2006... Grants/contracts Xilas to distribute TempTouch in Texas via $1 million award A Medical Device Daily Staff Report Xilas Medical (San Antonio) reported that it has been selected by the Texas Emerging Technology Fund (Houston) to...

Ciphergen notified of Nasdaq non-compliance.
June 2, 2006... Ciphergen notified of Nasdaq non-compliance Ciphergen Biosystems (Fremont, California) reported that it has received notification that it has failed to comply with Nasdaq National Market requirements for continuing listing because the...

Deals roundup.
June 2, 2006... Deals roundup Fujirebio acquires Swedish biotech, CanAg Diagnostics A Medical Device Daily Staff Report Fujirebio Diagnostics (Malvern, Pennsylvania), which focuses on in vitro diagnostics, reported that it has acquired 100% of the...

Bracco Group, IMS form cardio group for PET perfusion tech.
June 2, 2006... Bracco Group, IMS form cardio group for PET perfusion tech A Medical Device Daily Staff Report The Bracco Group (Milan, Italy) and Integrated Medical Solutions (IMS; Alexandria, Virginia) reported the formation of a new company,...

Agreements.
June 2, 2006... Agreements Source MDx, Colorado center in skin disease blood test pact A Medical Device Daily Staff Report University of Colorado at Denver and Health Sciences Center (UCDHSC; Aurora) and Source MDx (Boulder, Colorado) have entered...

Meeting to address Bayesian stat method.
June 2, 2006... Meeting to address Bayesian stat method The FDA's Center for Devices and Radiological Health (CDRH) has set a July 27 meeting to address its draft guidance for the proposed use of Bayesian statistics in assessing medical devices. The...

People in Places.
June 2, 2006... People in Places * Caroline Stewart has joined Piper Jaffray & Co. (Minneapolis) as a vice president and senior healthcare research analyst covering biotechnology companies. She will be based in the company's New York office. Stewart joins...

LDR Spine begins launch of U.S multi-level cervical disc trial.
June 2, 2006... LDR Spine begins launch of U.S multi-level cervical disc trial A Medical Device Daily Staff Report LDR Spine (Austin, Texas) reported that during a controlled launch, the first 15 patients were enrolled in a cervical artificial disc...

Product Briefs.
June 2, 2006... Product Briefs * BioLucent (Aliso Viejo, California), maker of the MammoPad breast cushion, reported two new initiatives for imaging centers that utilize digital mammography: a new MammoPad specially designed for digital mammography...

Colorectal cancer awareness driving colonoscopy advances.
June 5, 2006... Digestive Disease Week Colorectal cancer awareness driving colonoscopy advances By DIANA TUCKER Medical Device Daily Contributing Writer LOS ANGELES -- The convergence of four separate societies all focused on treatments for...

Financings roundup.
June 5, 2006... Financings roundup Alphatec prices shares at $9 each; Luna lowers IPO pricing to $32M A Medical Device Daily Staff Report Alphatec Holdings (Carlsbad, California) has priced its initial public offering (IPO) of 9.3 million shares...

International report.
June 5, 2006... International report St. Jude gets approvals for EnSite system sale in Japan A Medical Device Daily Staff Report St. Jude Medical (St. Paul, Minnesota) said it has received regulatory and reimbursement approvals from Japan's...

Combined chest, leg CT scans more effective to diagnose PE.
June 5, 2006... Combined chest, leg CT scans more effective to diagnose PE By KAREN YOUNG Medical Device Daily Staff Writer Physicians could improve their ability to accurately diagnose pulmonary embolism, which kills about 600,000 Americans a...

Deals roundup.
June 5, 2006... Deals roundup Renal Advantage buys centers; Thomson acquires MercuryMD A Medical Device Daily Staff Report Renal Advantage (Brentwood, Tennessee), the fourth largest provider of dialysis services in the U.S., reported that it has...

Briefly Noted.
June 5, 2006... Briefly Noted dj Orthopedics renamed DJO dj Orthopedics (San Diego), a provider of products and services that promote musculoskeletal health, said it has changed its name to DJO to better reflect the diversification of its business...

Court report.
June 5, 2006... Court report Fresenius' newly acquired Renal Care unit receives subpoena A Medical Device Daily Staff Report Fresenius Medical Care (Bad Homburg, Germany) reported that its wholly owned subsidiary, Renal Care Group (RCG; Nashville,...

Product Briefs.
June 5, 2006... Product Briefs * Cyberonics (Houston) reported the initiation of a study that will evaluate long-term clinical and economic outcomes for patients with treatment-resistant depression (TRD) who are treated with vagus nerve stimulation (VNS)...

People in Places.
June 5, 2006... People in Places * Christian Cabou has been appointed senior vice president and general counsel of Illumina (San Diego). Most recently, he spent five years as general counsel of GE Global Research. Illumina develops next-generation tools...

Reclassification attempt falls short on waveform reproduction.
June 6, 2006... Reclassification attempt falls short on waveform reproduction By MARK McCARTY Medical Device Daily Washington Editor GAITHERSBURG, Maryland -- The effort to reclassify bone growth stimulators (BGSs) undertaken by RS Medical...

Deals roundup.(Company overview)
June 6, 2006... Deals roundup AMS in $725 million acquisition of Laserscope's urology assets By HOLLAND JOHNSON Medical Device Daily Staff Writer Urology product company American Medical Systems Holdings (AMS; Minnetonka, Minnesota) said it...

Report from Europe.
June 6, 2006... Report from Europe U.S. firm gets 1st CE marks for xenograft implant line A Medical Device Daily Staff Report Regeneration Technologies (RTI; Alachua, Florida), a processor of orthopedic, cardiovascular and other biologic implants,...

Founder of Salick cancer centers sets sights on cardiovascular care.
June 6, 2006... Founder of Salick cancer centers sets sights on cardiovascular care By KAREN YOUNG Medical Device Daily Staff Writer Building on his previous success with outpatient cancer centers, Bernard Salick, MD, a California nephrologist and...

Court report.
June 6, 2006... Court report Palomar, Cutera report resolution of patent infringement lawsuits A Medical Device Daily Staff Report Palomar Medical Technologies (Burlington, Massachusetts), a researcher and developer of light-based systems for...

Financings roundup.
June 6, 2006... Financings roundup Viking in $8 million funding; Positron raises private $2M A Medical Device Daily Staff Report Viking Systems (San Diego), a maker of high-performance laparoscopic vision systems for use in minimally invasive...

Agreements roundup.
June 6, 2006... Agreements roundup Synergetics in distribution pact for Quantel's ophthalmic laser A Medical Device Daily Staff Report Synergetics USA (O'Fallon, Missouri) reported that it has signed a new three-year distribution agreement with...

People in Places.
June 6, 2006... People in Places * Ulf Boberg, PhD, who joined Affibody (Stockholm, Sweden) in January 2006 as senior vice president development, replaces as CEO Dr. Carl-Johan Dalsgaard who has been acting CEO of Affibody since December 2005. Dalsgaard...

Product Briefs.
June 6, 2006... Product Briefs * BioForm Medical (San Mateo, California), a developer of injectable implant products for soft tissue augmentation, reported the results of a clinical study confirming the long-term efficacy of Radiesse for the treatment of...

Healthcare IT both stirs activity, draws funding despite hurdles.
June 7, 2006... Healthcare IT both stirs activity, draws funding despite hurdles By MARK McCARTY Medical Device Daily Washington Editor WASHINGTON -- Healthcare information technology (HIT) issues are drawing a lot of ink and, according to one...

Financings roundup.
June 7, 2006... Financings roundup Endologix in $20M placement; Systems Xcellence to raise $50M A Medical Device Daily Staff Report Endologix (Irvine, California), developer of the Powerlink system for the minimally invasive treatment of abdominal...

International report.
June 7, 2006... International report Cynosure's Cynergy system approved for sale in S. Korea A Medical Device Daily Staff Report Cynosure (Westford, Massachusetts), manufacturer of an array of light-based aesthetic treatment systems, reported...

RITA's RFA technology enhanced by DC Bead from Biocompatibles.
June 7, 2006... American Society of Clinical Oncology meeting RITA's RFA technology enhanced by DC Bead from Biocompatibles A Medical Device Daily Staff Report RITA Medical Systems (Fremont, California), a medical device company focused solely on...

Court report.
June 7, 2006... Court report Kaiser kidney transplant program closure is target of class action A Medical Device Daily Staff Report A class action complaint has been filed in San Francisco Superior Court against Kaiser Permanente (Oakland,...

Briefly Noted.
June 7, 2006... Briefly Noted Microtest $7.5M capital improvement under way A $7.5 million capital improvement program under way at Microtest (Agawam, Massachusetts) is enhancing the firm's offering of medical device services and analytical services...

Deals roundup.
June 7, 2006... Deals roundup Rochester buys urology assets; SSI sells off-site reprocessing A Medical Device Daily Staff Report Rochester Medical (Stewartville, Minnesota) reported closing its previously disclosed transactions in connection...

Breast cancer test tech IDs advanced colon cancer genes.
June 7, 2006... ASCO notebook Breast cancer test tech IDs advanced colon cancer genes A Medical Device Daily Staff Report The National Surgical Adjuvant Breast and Bowel Project (NSABP; Pittsburgh) and Genomic Health (Redwood, California) reported...

Product Briefs.
June 7, 2006... Product Briefs * CardioDynamics (San Diego), a provider of impedance cardiography (ICG) technology, reported publication of the company's PREDICT (Prospective Evaluation and Identification of Decompensation by ICG Test) study,...

People in Places.
June 7, 2006... People in Places * Kay Larholt, a biostatistician with over 16 years experience in the pharmaceutical, biotechnology and medical device industries, has joined Abt Associates (Cambridge, Massachusetts) as vice president and executive...

Isolagen picks veteran industry exec Teti as chairman and CEO.
June 7, 2006... Isolagen picks veteran industry exec Teti as chairman and CEO A Medical Device Daily Staff Report Isolagen (Exton, Pennsylvania) has named Nicholas Teti Jr. chairman and CEO. Teti recently served as the chairman of the board and...

Heavy hitters push HIT as vision of tomorrow for U.S. healthcare.
June 8, 2006... HIMSS Summit 2006 Heavy hitters push HIT as vision of tomorrow for U.S. healthcare By MARK McCARTY Medical Device Daily Washington Editor WASHINGTON -- The Summit 2006 meeting of the Healthcare Information Management and...

Court report.
June 8, 2006... Court report Documents show Guidant failed to alert docs to malfunctions By DON LONG Medical Device Daily Managing Editor and Staff Reports Boston Scientific (Natick, Massachusetts) took on the potential for large legal...

Report from Europe.
June 8, 2006... Report from Europe Agendia closes on third round for diagnostic cancer arrays By CORMAC SHERIDAN Medical Device Daily Contributing Writer and Staff Reports Agendia (Amsterdam, the Netherlands) has closed a third funding...

Study to detect atherosclerosis using PET called "revolutionary".
June 8, 2006... Society of Nuclear Medicine annual meeting Study to detect atherosclerosis using PET called 'revolutionary' A Medical Device Daily Staff Report Using positron emission tomography (PET), the medical isotope 15O-water and cold...

Boston Sci, other major firms launch large public offerings.
June 8, 2006... Boston Sci, other major firms launch large public offerings A Medical Device Daily Staff Report A number of med-tech firms were busy in large financing and refinancing activities this week. Boston Scientific (Natick, Massachusetts)...

Deals roundup.
June 8, 2006... Deals roundup PH to buy key Western assets; Xenomics acquires AML marker A Medical Device Daily Staff Report Providential Holdings (PH; Huntington Beach, California) reported that it has signed an asset purchase agreement to...

Briefly Noted.
June 8, 2006... Briefly Noted Merge must complete filings to stay on Nasdaq Merge Technologies (doing business as Merge Healthcare; Milwaukee) reported that the company received a written notification from the Nasdaq Listing Qualifications Panel...

Financings roundup.
June 8, 2006... Financings roundup North American adding $24M, seeks Nasdaq reinstatement A Medical Device Daily Staff Report North American Scientific (Chatsworth, California) reported that it has entered into an agreement to raise $24 million in...

BrainLAB unveils iPlan software or 'holistic' cancer treatment.
June 8, 2006... American Society of Clinical Oncology meeting BrainLAB unveils iPlan software or 'holistic' cancer treatment A Medical Device Daily Staff Report BrainLAB (Westchester, Illinois) reported unveiling its portfolio for clinical...

Brigham pharmacy exec makes barcodes, RFID business case.
June 9, 2006... HIMSS Summit 2006 Brigham pharmacy exec makes barcodes, RFID business case By MARK McCARTY Medical Device Daily Washington Editor WASHINGTON -- The second day of the annual meeting of the Healthcare Information Management and...

Deals roundup.
June 9, 2006... Deals roundup Haemonetics' $26M Arryx buy provides major new platform By HOLLAND JOHNSON Medical Device Daily Associate Managing Editor Automated blood processing systems company Haemonetics (Braintree, Massachusetts) and...

Report from Europe.
June 9, 2006... Report from Europe Cardiac marker market seen on growth curve in Europe A Medical Device Daily Staff Report The market for cardiac markers used in primary care is experiencing a tremendous rate of growth across Europe due to their...

GE begins first-in-man study of PET molecular imaging agent.
June 9, 2006... GE begins first-in-man study of PET molecular imaging agent By KAREN YOUNG Medical Device Daily Staff Writer GE Healthcare (Chalfont St. Giles, UK) reported earlier this week that it has initiated a "first-in-man" clinical study of...

Washington roundup.
June 9, 2006... Washington roundup Group blasts study indicating 'over-diagnosis' of lung cancer A Medical Device Daily Staff Report A group focused on reducing the mortality from lung cancer has issued a statement lambasting a new report by the...

Financings roundup.
June 9, 2006... Financings roundup AMO prices its $450M offering; Minrad over-allotment $4.9M A Medical Device Daily Staff Report Advanced Medical Optics (AMO; Santa Ana, California) reported the pricing of a private offering of $450 million of...

Agreements roundup.
June 9, 2006... Agreements roundup Neoprobe in distribution pact with Estech for Quantix/OR A Medical Device Daily Staff Report Neoprobe (Dublin, Ohio), a developer of oncology and cardiovascular surgical and diagnostic products, said that it has...

Court report.
June 9, 2006... Court report UltiMed files suit against BD alleging antitrust violations A Medical Device Daily Staff Report UltiMed (St. Paul, Minnesota) said it has filed a lawsuit in U.S. District Court for the District of Minnesota against BD...

Briefly Noted.
June 9, 2006... Briefly Noted Telzuit launches new Statpatch campaign Telzuit Medical Technologies (Orlando, Florida), providing advanced mobile medicine, reported a new branding campaign for its Statpatch wireless heart monitor. "Statpatch"...

People in Places.
June 9, 2006... People in Places * Carlos Escobar has joined MedAptus (Boston), a provider of point-of-care technologies to the healthcare industry. Escobar will lead MedAptus' national sales force as well as a rapid expansion of the company's customer...

Digene Chairman/CEO Jones sets retirement after 16 years.
June 9, 2006... Digene Chairman/CEO Jones sets retirement after 16 years A Medical Device Daily Staff Report Evan Jones, chairman and CEO of Digene (Gaithersburg, Maryland), expects to retire as CEO during the company's 2007 fiscal year, once a...

Product Briefs.
June 9, 2006... Product Briefs * Acusphere (Baltimore) reported the completion of enrollment in the second of its two Phase III clinical trials, RAMP-2 (Real-time Assessment of Myocardial Perfusion-2), for the company's lead product candidate, AI-700....

Analyst questions timing of Cyberonics stock option grant.
June 12, 2006... Analyst questions timing of Cyberonics stock option grant By HOLLAND JOHNSON Medical Device Daily Associate Managing Editor Vagus Nerve Stimulation (VNS) therapy company Cyberonics (Houston) said in a prepared statement that an...

Inhaler, insulin 'pen' will push easier diabetes management.
June 12, 2006... American Diabetes Association annual meeting Inhaler, insulin 'pen' will push easier diabetes management By DON LONG Medical Device Daily Managing Editor Diabetes is a tough disease to manage -- primarily because it requires...

International report.
June 12, 2006... International report Additional sites okayed for Medidur device Phase III trial A Medical Device Daily Staff Report Global bio-nanotech company pSivida Ltd. (Perth, Australia) and development partner Alimera Sciences (Alpharetta,...

Financings roundup.
June 12, 2006... Financings roundup NxStage to raise about $44.6M; Hanger begins note tender offer A Medical Device Daily Staff Report NxStage Medical (Lawrence, Massachusetts), manufacturer of the NxStage System One portable kidney dialysis...

Court report.
June 12, 2006... Court report SEC sets $750M Bristol-Myers shareholder compensation A Medical Device Daily Staff Report The SEC reported that $750 million would be distributed to compensate shareholders injured by fraudulent earnings management at...

Deals roundup.
June 12, 2006... Deals roundup Positron buys Cadenza rights; Encore selling off Slendertone A Medical Device Daily Staff Report Positron (Houston, Texas), a manufacturer of positron emission tomography (PET) systems, reported acquiring exclusive...

Agreements roundup.
June 12, 2006... Agreements roundup LGC and Gentris in licensing pact for diagnostic products A Medical Device Daily Staff Report LGC (Teddington, UK), an independent analytical laboratory, and Gentris (Research Triangle Park, North Carolina), a...

Briefly Noted.
June 12, 2006... Briefly Noted Clearant hires four territory representatives Clearant (Los Angeles), which focuses on pathogen inactivation for biological products, reported it has achieved the first important milestone in its direct distribution...

People in Places.
June 12, 2006... People in Places * Bio Solutions Franchise (Hattiesburg, Mississippi), the exclusive marketing company for Bio-Solutions Manufacturing, has hired Mike Silverman to head its BioRemediation Services franchise program as president....