Medical Device Week articles from August 2006

Medical Device Week archives from August 2006

Washington roundup.
August 1, 2006... Washington roundup FCC inquiry seeks feedback on healthcare use of RF spectra By MARK McCARTY Medical Device Daily Washington Editor WASHINGTON -- The Federal Communications Commission (FCC) has published a notice of inquiry...

Millipore, other firms unveil new products on Expo floor.
August 1, 2006... AACC annual meeting Millipore, other firms unveil new products on Expo floor By KAREN YOUNG Medical Device Daily Staff Writer CHICAGO -- Millipore (Billerica, Massachusetts), a provider of solutions to clinical labs, among...

Report from Europe.
August 1, 2006... Report from Europe Sorin gets FDA okay for heart valve work in Saluggia plant A Medical Device Daily Staff Report Sorin Group (Milan, Italy), a leader in cardiac surgery solutions, has received clearance from the FDA to manufacture...

Radiation-killed bacteria can elicit T-cell immune response.
August 1, 2006... Nuking Listerium monocytogenes Radiation-killed bacteria can elicit T-cell immune response By ANETTE BREINDL Medical Device Daily Science Editor Here comes the neutron bomb for vaccines. A paper published in the July issue...

Financings roundup.
August 1, 2006... Financings roundup Celsion receives 3rd payment on $15M loan from Boston Sci A Medical Device Daily Staff Report Celsion (Columbia, Maryland), a developer of heat-activated systems for treating cancer, yesterday reported that...

Briefly Noted.
August 1, 2006... Briefly Noted AMDL regains Amex compliance AMDL (Tustin, California), developer of tests for the early detection of cancer and other serious diseases, reported that on July 17 it received a letter from the American Stock Exchange...

Reports back Calypso system's ability to track tumor motion.
August 1, 2006... AAPM annual meeting Reports back Calypso system's ability to track tumor motion A Medical Device Daily Staff Report Clinical reports on the 4-D Localization System made by Calypso Medical (Seattle) are being presented this week at...

Deals roundup.
August 1, 2006... Deals roundup Hemagen in sale of building; MD-IT buys Trans Med Plus A Medical Device Daily Staff Report Hemagen Diagnostics (Columbia, Maryland), a maker of diagnostic test kits, reported the sale of a manufacturing building for...

Agreements roundup.
August 1, 2006... Agreements roundup Collagen Matrix in pact with Stryker on collagen nerve cuff A Medical Device Daily Staff Report Collagen Matrix (Franklin Lakes, New Jersey) reported that it has signed an agreement with Stryker Orthopaedics...

People in Places.
August 1, 2006... People in Places * Kevin Hicks has been named president and CEO of Research Medical Center (Kansas City, Missouri), a part of the HCA hospital chain. Hicks most recently served as president/CEO of Overland Park Regional Medical Center....

Product Briefs.
August 1, 2006... Product Briefs * ConvaTec (Skillman, New Jersey) reported the availability of its enhanced Little Ones pediatric line of ostomy products designed specifically for the pediatric population, with thinner landing zones, welded edges for added...

Cook completes enrollment in thoracic graft system trial.
August 1, 2006... Cook completes enrollment in thoracic graft system trial A Medical Device Daily Staff Report Cook (Bloomington, Indiana) reported completing enrollment in its Study of Thoracic Aortic Aneurysm Repair with the Zenith TX2 Thoracic TAA...

Senate Dems continue to see Plan B as FDA chief litmus.
August 2, 2006... Senate Dems continue to see Plan B as FDA chief litmus By MARK McCARTY Medical Device Daily Washington Editor WASHINGTON -- Yesterday's confirmation hearing for Andrew von Eschenbach to head the FDA never approached an actual vote,...

SmartPill GI diagnostic enters North America, eyes Europe.
August 2, 2006... SmartPill GI diagnostic enters North America, eyes Europe By MARK McCARTY Medical Device Daily Washington Editor Diagnostic systems continue to shrink, very notably those allowing physicians dealing with gastrointestinal issues to...

Report from Europe.
August 2, 2006... Report from Europe HemoCue rolls out system for white blood cell testing A Medical Device Daily Staff Report HemoCue (Angelholm, Sweden) has unveiled an entirely new single-analyte point-of-care (POC) testing system for...

Financings roundup.
August 2, 2006... Financings roundup Cardiovascular Systems has $25 million 1st funding round A Medical Device Daily Staff Report Cardiovascular Systems (CSI; St. Paul, Minnesota), developer of the Orbital Atherectomy System (OAS), a treatment for...

Court report.
August 2, 2006... Court report Medtronic payment challenged; Boston Sci and St. Jude settle A Medical Device Daily Staff Report Big medical device makers were prominent in the legal arena this week, with a whistleblower challenging a $40 million...

Briefly Noted.(Buildings and facilities)(Brief article)
August 2, 2006... Briefly Noted Beacon opens Bay area office Beacon Partners (Weymouth, Massachusetts), a healthcare management consulting firm, reported opening a new office in the San Francisco Bay area, allowing Beacon to expand its services to a...

Spacelabs closes Del Mar buy; Hanger adds limb/brace firm.(Company overview)
August 2, 2006... Spacelabs closes Del Mar buy; Hanger adds limb/brace firm A Medical Device Daily Staff Report OSI Systems (Hawthorne, California) reported that its subsidiary, Spacelabs Healthcare (Issaquah, Washington), completed the acquisition of...

Deals roundup.
August 2, 2006... Deals roundup AMI to buy NanoAmp units; MedQuist licenses software A Medical Device Daily Staff Report AMI Semiconductor (Pocatello, Idaho), a subsidiary of AMIS Holdings, said that it has agreed to acquire the Ultra Low Power...

Agreements roundup.
August 2, 2006... Agreements roundup HIMSS, Internet2 partner on new networking solution A Medical Device Daily Staff Report The Healthcare Information and Management Systems Society (HIMSS; Chicago) and Internet2 (Ann Arbor, Michigan) reported that...

Product Briefs.
August 2, 2006... Product Briefs * Custom Comfort Medtek (Winter Park, Florida), a provider of medical furniture and supplies, reported launch of its Classic 8010 and Contemporary 8020 exam table series, available with various storage options and features,...

CryoCor planning to submit amendment to PMA for AFL.
August 2, 2006... CryoCor planning to submit amendment to PMA for AFL A Medical Device Daily Staff Report CryoCor (San Diego), a developer of treatments of cardiac arrhythmias, reported that, based upon its July 26 meeting with FDA officials, it plans...

People in Places.(appointment of Stuart Patterson as Chief Executive Officer)(appointment of Dennis O'Brien as Vice President)(appointment of John Schafer as Chief Executive Officer)(Brief article)
August 2, 2006... People in Places * Stuart Patterson has joined AgION Technologies (Wakefield, Massachusetts) as CEO and a member of the board of directors. Before joining AgION, he was president of Patterson Leadership Consulting, prior to which he was...

HHS final rules for HIT sharing posted, into effect in 60 days.
August 3, 2006... HHS final rules for HIT sharing posted, into effect in 60 days By MARK McCARTY Medical Device Daily Washington Editor WASHINGTON - The Department of Health and Human Services (HHS) has finished its work on final regulations to...

Deals roundup.(Company overview)
August 3, 2006... Deals roundup Tyco Healthcare takes 1st step in $108 million buy of Airox A Medical Device Daily Staff Report Tyco Healthcare (Mansfield, Massachusetts) yesterday said it has agreed to acquire 37.25% of the share capital of Airox...

Report from Europe.
August 3, 2006... Report from Europe More high-technology caution looms in European Parliament By PETER O'DONNELL Medical Device Daily Contributing Writer and Staff Reports While the European Union agonizes over whether to allow stem cell...

'Mosquito' uses proboscis-type device to break through plaque.
August 3, 2006... 'Mosquito' uses proboscis-type device to break through plaque By KAREN YOUNG Medical Device Daily Staff Writer Mosquitoes - dreaded creatures. But funny the way nature often leads the way. The Mosquito, a needle holder device...

Court report.
August 3, 2006... Court report Impath execs get big penalties, but one 85-year term reduced A Medical Device Daily Staff Report Anuradha Saad, former CEO and chairman of Impath (New York), and Richard Adelson, the company's former president/chief...

Agreements roundup.
August 3, 2006... Agreements roundup Invacare in distribution pact with AEIOMed for sleep sales A Medical Device Daily Staff Report Invacare (Elyria, Ohio) reported the signing of a multi-year distribution agreement with AEIOMed (Minneapolis)....

Briefly Noted.
August 3, 2006... Briefly Noted Calypte withdraws from Amex Calypte Biomedical (Lake Oswego, Oregon) reported filing a request to withdraw its common stock from listing on the American Stock Exchange. Amex previously advised Calypte that it was not in...

Gene Logic to release 80 with cutback of Genomics division.
August 3, 2006... Gene Logic to release 80 with cutback of Genomics division A Medical Device Daily Staff Report Gene Logic (Gaithersburg, Maryland) reported that it plans to eliminate about 80 positions in its Genomics Division and related corporate...

Product Briefs.
August 3, 2006... Product Briefs * HydroCision (Billerica, Massachusetts) reported the initial release of its SpineJet XL MIS Fusion Preparation System into the spine segment of the orthopedic market in the U.S. The SpineJet XL MIS Fusion Preparation System...

Enrollment complete in pivotal study of Northfield's PolyHeme.
August 3, 2006... Enrollment complete in pivotal study of Northfield's PolyHeme A Medical Device Daily Staff Report Northfield Laboratories (Evanston, Illinois) said patient enrollment is complete in its pivotal Phase III trauma study with PolyHeme, the...

People in Places.
August 3, 2006... People in Places * Pathology Partners (Irving, Texas), a provider of comprehensive gastrointestinal diagnostic services and technology support systems, has appointed three key executives and changed its name to Caris Diagnostics. The new...

Reactions to revised IPPS rule positive but still rather guarded.
August 4, 2006... Reactions to revised IPPS rule positive but still rather guarded By MARK McCARTY Medical Device Daily Washington Editor WASHINGTON -- The publication this week of final rules addressing the federal government's hospital in-patient...

Theragenics buys Galt Medical via $31 million cash/stock deal.(Company overview)
August 4, 2006... Theragenics buys Galt Medical via $31 million cash/stock deal A Medical Device Daily Staff Report Theragenics (Buford, Georgia), a company serving the cancer treatment and surgical markets, reported that it has acquired Galt Medical...

Report from Europe.
August 4, 2006... Report from Europe 'Fat controller' links cystic fibrosis, diabetes, obesity By SHARON KINGMAN Medical Device Daily Contributing Writer and MDD Staff Reports Scientists have identified a crucial metabolic complex: If you...

Radiating moving lung tumors -- a Cyberknife treatment success?
August 4, 2006... AAPM annual meeting notebook Radiating moving lung tumors -- a Cyberknife treatment success? A Medical Device Daily Staff Report Super-intense radiation delivered by a robotic arm eradicated lung tumors in some human patients just...

Agreements roundup.
August 4, 2006... Agreements roundup VivoMetrics, RAE Systems in first responder wireless work A Medical Device Daily Staff Report VivoMetrics (Ventura, California), developer of the LifeShirt -- described as "the first real-time physiologic...

Financings roundup.
August 4, 2006... Financings roundup Sicel closes 'F' funding round; Staar puts $15 million on shelf A Medical Device Daily Staff Report Sicel Technologies (Raleigh, North Carolina), a manufacturer of implantable sensors and surface dosimeters...

Deals roundup.
August 4, 2006... Deals roundup BioDelivery buying QLT's disc drug delivery system for $3M A Medical Device Daily Staff Report BioDelivery Sciences International (BDSI; Morrisville, North Carolina), a company focused on acute care products,...

Payment to egg donors OK'd for stem cell research in UK.
August 4, 2006... Payment to egg donors OK'd for stem cell research in UK By NUALA MORAN Medical Device Daily International Correspondent LONDON -- Scientists in the UK have breached an ethical barrier in embryonic stem cell research, receiving...

Product Briefs.
August 4, 2006... Product Briefs * Clearant (Los Angeles) reported that it has expanded its product portfolio of allograft implants available through its direct sales force to include Clearant Process sterile soft tissue implants for allograft sport...

People in Places.(appointments of Micro Imaging Technology and NightHawk)(Brief article)
August 4, 2006... People in Places * Micro Imaging Technology (MIT; San Clemente, California) reported that Floyd Panning has stepped down as CEO and director. Michael Brennan has been named president/CEO and a director. George Farquhar has been appointed...

Washington roundup.
August 7, 2006... Washington roundup FDA toxicology group wields technology to combat bioterror By MARK McCARTY Medical Device Daily Washington Editor WASHINGTON -- Despite criticisms that its plate more than runneth over, the FDA is taking...

METI manikins a 'natural' way for certifying disaster care.
August 7, 2006... 'Breathes . . . salivates . . . pees' METI manikins a 'natural' way for certifying disaster care By DON LONG Medical Device Daily Managing Editor Go to a movie these days, and more often than not, you'll be viewing characters...

International report.(Company overview)
August 7, 2006... International report Staar gets Chinese marketing okay for Visian ICL product A Medical Device Daily Staff Report Staar Surgical (Monrovia, California), a manufacturer of minimally invasive ophthalmic products, said it has received...

Disc Dynamics receives FDA go-ahead for DASCOR study.
August 7, 2006... Disc Dynamics receives FDA go-ahead for DASCOR study By KAREN YOUNG Medical Device Daily Staff Writer Disc Dynamics (Eden Prairie, Minnesota) is on a quest for pre-market approval (PMA) of its "novel concept" in its DASCOR Disc...

Court report.
August 7, 2006... Court report Group: Administration 'unduly influenced' FDA Plan B review A Medical Device Daily Staff Report The advocacy group Center for Reproductive Rights (New York) said last week that depositions released in its lawsuit...

Financings roundup.
August 7, 2006... Financings roundup Osiris prices IPO to raise $39M; $6.5M ADS offering for EDAP A Medical Device Daily Staff Report Osiris Therapeutics (Baltimore) priced 3.5 million shares of stock in its original public offering (IPO) at $11 --...

Deals roundup.
August 7, 2006... Deals roundup Telzuit acquires PDS Imaging as it nears Statpatch rollout A Medical Device Daily Staff Report Telzuit Medical Technologies (Orlando, Florida) has acquired PDS Imaging (PDS; Orlando), a mobile ultrasound and cardiac...

Agreements roundup.
August 7, 2006... Agreements roundup ThermoGenesis to get $1M in milestones via Biomet Bio pact A Medical Device Daily Staff Report ThermoGenesis (Rancho Cordova, California) report-ed entering a development, license and supply agreement with Biomet...

Product Briefs.
August 7, 2006... Product Briefs * Innovasis (Salt Lake City) said it has submitted its PEEK Box System to the FDA for 510(k) clearance. The PEEK Box System, previously 510(k)-cleared as a cement restrictor, is used as a Vertebral Body Replacement within...

People in Places.(appointments )(Brief article)
August 7, 2006... People in Places * Lawrence Deering has been named an operating partner at Behrman Capital (New York/San Francisco), to oversee the company's portfolio of healthcare companies and identify new healthcare investments. Deering most recently...

Meeting dips 'foot in water' of tough payment reform plan.
August 8, 2006... Leadership Summit on Healthcare Quality & Pay-For-Performance Meeting dips 'foot in water' of tough payment reform plan By MARK McCARTY Medical Device Daily Washington Editor BOSTON -- "Assessing the sustainability of payment...

Incentives, quality reporting, public participation debated.
August 8, 2006... Leadership Summit on Healthcare Quality & Pay-For-Performance Incentives, quality reporting, public participation debated By MARK McCARTY Medical Device Daily Washington Editor BOSTON -- The second day of the fourth annual...

Report from Europe.
August 8, 2006... Report from Europe Misonix in Hungarian market with the Sonablate 500 system A Medical Device Daily Staff Report Misonix (Farmingdale, New York), a developer of ultrasonic technology for the treatment of cancer and other health...

Deals roundup.(Company overview)
August 8, 2006... Deals roundup Orthofix to acquire Blackstone in cash deal valued at $333M By DON LONG Medical Device Daily Managing Editor Orthofix International (Huntersville, North Carolina) yesterday reported proposing a transaction that...

Utah Medical requests review of the 'abusive' FDA process.
August 8, 2006... Utah Medical requests review of the 'abusive' FDA process By HOLLAND JOHNSON Medical Device Daily Associate Managing Editor Utah Medical Products (UTMD; Salt Lake City) said it has asked the federal government to review its...

Court report.
August 8, 2006... Court report Delcath suit cites omissions by Ladd in potential takeover A Medical Device Daily Staff Report Delcath Systems (Stamford, Connecticut), a developer of perfusion technology for delivery of therapeutic agents, reported...

Financings roundup.
August 8, 2006... Financings roundup Biomaterials storage company BioStorage raises 'A' $5 million A Medical Device Daily Staff Report BioStorage Technologies (BST; Indianapolis), a provider of biomaterial storage, inventory management and cold...

Agreements.
August 8, 2006... Agreements StatSure in accord with IMI to market HIV diagnostics A Medical Device Daily Staff Report StatSure Diagnostic Systems (Framingham, Massachusetts) said it has signed a binding term sheet with Inverness Medical Innovations...

Orbasone Mobile unit formed to provide shock wave service.
August 8, 2006... Orbasone Mobile unit formed to provide shock wave service A Medical Device Daily Staff Report Orthometrix (White Plains, New York) reported that it has formed Orbasone Mobile as a subsidiary to offer providers, such as those with...

Product Briefs.(briefs)
August 8, 2006... Product Briefs * Collagen Matrix (Franklin Lakes, New Jersey) said it has received FDA 510(k) clearance of its Collagen Nerve Wrap for the indication of management of peripheral nerve injuries in which there has been no substantial loss of...

People in Places.
August 8, 2006... People in Places * J. Richard Iler has been named CFO of bioMetrx (Jericho, New York) and has been appointed to the company's board of directors, succeeding Frank Giannuzzi, who resigned to pursue other interests. Previously Iler was CFO...

Cost-effective technology could reduce 50% health cost bloat.
August 9, 2006... Leadership Summit on Healthcare Quality & Pay-For-Performance Cost-effective technology could reduce 50% health cost bloat By MARK McCARTY Medical Device Daily Washington Editor BOSTON -- In an afternoon keynote on the second...

Tough legal issues hover over payment-for-quality terrain.
August 9, 2006... Leadership Summit on Healthcare Quality & Pay-For-Performance Tough legal issues hover over payment-for-quality terrain By MARK McCARTY Medical Device Daily Washington Editor BOSTON -- Proponents of pay for performance (P4P)...

Report from Europe.
August 9, 2006... Report from Europe Respironics, German firm in accord on CO2 sensor tech A Medical Device Daily Staff Report Sartorius (Goettingen, Germany) and Respironics (Murrysville, Pennsylvania) have signed an agreement that provides for...

Deals roundup.
August 9, 2006... Deals roundup Celsi International buys IVT for $30 million and earn-outs A Medical Device Daily Staff Report Celsis International (Chicago), a life science products and services company, reported that it has acquired In Vitro...

Orqis adds $10M debt funding; Dilon wraps up $7.25M offering.
August 9, 2006... Orqis adds $10M debt funding; Dilon wraps up $7.25M offering A Medical Device Daily Staff Report Orqis Medical (Lake Forest, California), a clinical-stage company developing devices for the treatment of congestive heart failure (CHF),...

Financings roundup.
August 9, 2006... Financings roundup OrthoClear adds $10M in 'D'; MedaSorb gets $5.25 million A Medical Device Daily Staff Report 3i Venture Capital (Menlo Park, California) reported leading a $10 million series D investment in OrthoClear Holdings...

Court report.
August 9, 2006... Court report Delcath files vs. ex-staffer in its dispute with Laddcapp A Medical Device Daily Staff Report Delcath Systems (Stamford, Connecticut) reported filing a complaint in Connecitcut Superior Court in Stam-ford against...

Grants/contracts.
August 9, 2006... Grants/contracts InterSystems in DoD contract valued at up to $63 million A Medical Device Daily Staff Report InterSystems (Cambridge, Massachusetts) said it has been selected to provide its CACHE post-relational database software...

Agreements roundup.
August 9, 2006... Agreements roundup Advocos promotes EndoTool in MD Scientific accord A Medical Device Daily Staff Report Advocos (Kennesaw, Georgia), a contract sales organization that provides sales and marketing services to the pharmaceutical,...

Briefly Noted.
August 9, 2006... Briefly Noted CryoCor 'cures' Nasdaq non-compliance CryoCor (San Diego), which is focused on the treatment of cardiac arrhythmias, reported the receipt of a letter from Nasdaq regarding a brief period of non-compliance with Nasdaq's...

Product Briefs.
August 9, 2006... Product Briefs * Calypso Medical Technologies (Seattle) said the FDA has granted 510(k) clearance for the Calypso 4D Localization System, which uses electromagnetic technology in conjunction with implanted Beacon transponders in the...

People in Places.
August 9, 2006... People in Places * Michael Adams has been named president/CEO of CardioTech (Wilmington, Massachusetts), replacing Dr. Michael Szycher. Adams has been serving as vice president of regulatory affairs and business development and will...

CMS proposes Medicare cuts for many outpatient services.
August 10, 2006... CMS proposes Medicare cuts for many outpatient services By HOLLAND JOHNSON Medical Device Daily Associate Managing Editor Among a laundry list of proposed changes to policies and payment for hospital outpatient services unveiled on...

Pilot program shows well, but duration of effect not yet known.
August 10, 2006... P4P leadership summit Pilot program shows well, but duration of effect not yet known By MARK McCARTY Medical Device Daily Washington Editor BOSTON -- The plethora of pilot projects designed to evaluate pay-for-performance...

Report from Europe.
August 10, 2006... Report from Europe Chasing next-generation stents, Axordia working with Lombard By NUALA MORAN Medical Device Daily Contributing Writer And MDD Staff Reports Axordia (Sheffield, UK) reported plans for the clinical...

Financings roundup.
August 10, 2006... Financings roundup Xtent latest device firm in IPO waters; Medical CV pulls offer A Medical Device Daily Staff Report Xtent (Menlo Park, California) has broken a several weeks hiatus of initial public offering (IPO) filings in the...

Washington roundup.
August 10, 2006... Washington roundup FDA rolls out new task force focusing on nanotech issues By DON LONG Medical Device Daily Managing Editor In an initiative that some might place under the "about time" category, the FDA yesterday reported...

Deals roundup.
August 10, 2006... Deals roundup Edwards selling its perfusion products business to Nipro A Medical Device Daily Staff Report Edwards Lifesciences (Irvine, California) reported that it has agreed to sell its remaining perfusion products business to...