Medical Device Week articles from November 2007

Medical Device Week archives from November 2007

Telemonitoring takes face-to-face requirement out of doctor's visit.
November 1, 2007... Savings, better care... but lacking reimbursement Telemonitoring takes face-to-face requirement out of doctor's visit By MARK McCARTY Medical Device Daily Washington Editor The need to ease disease while also cutting costs is...

U.S. and Europe 'plugging in' to medical device certification.
November 1, 2007... World of Healthcare IT U.S. and Europe 'plugging in' to medical device certification By JOHN BROSKY Medical Device Daily European Editor VIENNA -- More and more medical devices are plugging into information systems at...

International report.
November 1, 2007... International report Canadian study cites accuracy of HPV testing with Capture 2 A Medical Device Daily Staff Report The first randomized, controlled study in North America of HPV testing as a stand-alone screen concluded that it...

Audio Conference focuses on personalized medicine.(Conference news)
November 1, 2007... Audio Conference focuses on personalized medicine Reality will soon come to medical practices specifically geared to individuals based on their genetic makeup. A new report issued by the HHS pinpoints work that lies ahead for the...

Patent watch.
November 1, 2007... Patent watch ev3 agrees to settle patent suit,takes in $20.2M in 3Q charges A Medical Device Daily Staff Report ev3 (Plymouth, Minnesota) said it agreed in principle to resolve patent infringement and other litigation with the...

Today's MDD food for med-tech thought.
November 1, 2007... Today's MDD food for med-tech thought "There is immense possibility in this technology to improve outcomes and reduce costs." -- Steve Morse, director of marketing for Boston Scientific's Latitude monitoring system, concerning the...

Ivax putting Parsec development on hold - focus now on Mago 4.(Ivax Diagnostics)
November 1, 2007... Ivax putting Parsec development on hold -- focus now on Mago 4 By AMANDA PEDERSEN Medical Device Daily Staff Writer Ivax Diagnostics (Miami) has reported that it is placing further development of its Parsec laboratory automation...

November med-tech meetings/conferences.(medical technology)(Calendar)
November 1, 2007... November med-tech meetings/conferences * Nov. 2 American Electrology Association Annual Weekend Convention and Exhibitor's Showcase San Francisco; Marriott Airport Hotel electrology.com/convention.htm * Nov. 3-7 ...

Financings roundup.
November 1, 2007... Financings roundup Harmony raises 'B' $28 million; OIS issues $2.75 million in notes A Medical Device Daily Staff Report Harmony Information Systems (Reston, Virginia), a provider of software solutions for the health and human...

Briefly Noted.(Brief article)
November 1, 2007... Briefly Noted Biopure changes trading symbol Biopure (Cambridge, Massachusetts) said that the trading symbol for its Class A common stock will revert from BPURD to BPUR. Outstanding warrants that trade on the OTCBB will revert to the...

Washington roundup.
November 1, 2007... Washington roundup CMS doles out funding to MACS to streamline fee payment system A Medical Device Daily Staff Report The Centers for Medicare & Medicaid Services reported awarding two contracts for the combined administration of...

Agreements.
November 1, 2007... Agreements Accuray in pact with Still for patient positioning system A Medical Device Daily Staff Report Accuray (Sunnyvale, California), a radiosurgery company, said it has entered into a partnership with Still River Systems...

Product Briefs.
November 1, 2007... Product Briefs * LCA-Vision (Cincinnati) reported plans for a nationwide rollout of Advanced Medical Optics' IntraLase femtosecond technology at its LasikPlus vision centers throughout the U.S. This decision was made by LCA-Vision in...

Bone marrow harvesting system from StemCor is FDA-cleared.(Food and Drug Administration, StemCor Systems )(Brief article)
November 1, 2007... Bone marrow harvesting system from StemCor is FDA-cleared A Medical Device Daily Staff Report StemCor Systems (Menlo Park, California), a device company developing systems for regenerative medicine, reported receiving 510(k) clearance...

People in Places.(Brief article)
November 1, 2007... People in Places * Ed Cannon, PhD, was named CEO of AerovectRx (Norcross, Georgia). Cannon has previously been president/CEO of AdipoGenix. AerovectRx is an aerosol drug delivery and therapeutics company. * Dennis Rosenberg was named...

Growth in technical weaponry targets No. 2 cause of death.
November 2, 2007... ASTRO 2007 Growth in technical weaponry targets No. 2 cause of death By LARRY HAIMOVITCH Medical Device Daily Contributing Writer LOS ANGELES -- The 49th annual meeting of the American Society for Therapeutic Radiology and...

CCHIT's Leavitt sees device certification as market mover.(Certification Commission for Healthcare Information Technology, Mark Leavitt)
November 2, 2007... World of Healthcare IT CCHIT's Leavitt sees device certification as market mover By JOHN BROSKY Medical Device Daily European Editor VIENNA -- A pioneer of electronic health records (EHRs), Mark Leavitt, MD, is chairman of the...

Financings.(BD company revenues)
November 2, 2007... Financings BD reports record revenues in '07 for fourth quarter and full year By AMANDA PEDERSEN Medical Device Daily Staff Writer BD (Franklin Lakes, New Jersey) reported record quarterly revenues of $1.651 billion for the...

Emphasys wins expedited review status for Zephyr EBV from FDA.
November 2, 2007... Emphasys wins expedited review status for Zephyr EBV from FDA By AMANDA PEDERSEN Medical Device Daily Staff Writer Until recently, the primary options for patients diagnosed with advanced emphysema included lung volume reduction or...

Patent watch.
November 2, 2007... Patent watch Boston Sci to appeal jury ruling of infringement of Cordis IP A Medical Device Daily Staff Report Boston Scientific (Natick, Massachusetts) reported that a jury in U.S. District Court in San Francisco has ruled that it...

Today's MDD food for med-tech thought.(Medical Device Daily, medical technology)(Brief article)
November 2, 2007... Today's MDD food for med-tech thought "Certification is a powerful lever to move a market, but also that it is a lever made of wood that will break if you yank on it too hard." --Mark Leavitt, chairman of CCHIT, commenting on the need...

Deals roundup.(Lingualcare )
November 2, 2007... Deals roundup Siemens nears Dade buy close; Mediware acquires IMS assets A Medical Device Daily Staff Report Siemens (Munich, Germany) yesterday reported that with expiration of a cash tender offer expired at midnight, Oct. 31, it...

Financings roundup.
November 2, 2007... Financings roundup Biopure has priced 16.85 million shares in order to raise $13M A Medical Device Daily Staff Report Biopure (Cambridge, Massachusetts) reported the pricing of an underwritten public offering of stock and warrants....

Audio conference helps companies avoid device recall.(Conference news)
November 2, 2007... Audio conference helps companies avoid device recall Med-tech companies must have systems in place that receive, investigate, analyze, and act on complaints from users, patients, and professionals. FDA's Center for Devices and Radiological...

Wireless technologies helping to push personalized medicine.
November 2, 2007... Wireless technologies helping to push personalized medicine VIENNA -- The first impression of one showroom display at the World of Health IT gathering here was like looking at the hottest, freshest necklace worn by a rapper, not the leading...

Briefly Noted.(Phluid product development with Syprosoft Engineering)(Brief article)
November 2, 2007... Briefly Noted Sysprosoft to develop Phluid pump Phluid (Laguna Hills, California) reported that it has retained Syprosoft Engineering, a division of Syprosoft (Irvine, California), to assist in the development of an ambulatory diabetes...

Product Briefs.
November 2, 2007... Product Briefs * Cogon Systems (Pensacola, Florida) has completed deployment of the health information exchange (HIE) for South Florida known as the South Florida Health Information Initiative (SFHII; Miami). Authorized physicians and...

People in Places.(Brief article)
November 2, 2007... People in Places * American Medical Technologies (Corpus Christi, Texas) reported that Judd Hoffman has been named chairman of the board of directors. Hoffman was previously VP of world wide sales for Remedent. AMT makes dental products....

Medtronic launches InSite trial of InterStim bladder control.(Clinical report)
November 2, 2007... Medtronic launches InSite trial of InterStim bladder control A Medical Device Daily Staff Report Medtronic (Minneapolis) reported the initiation of the InSite Trial, a post-market study of its InterStim therapy for urinary control, a...

Congress seen likely to cover cuts of '08 Part B doctors' fees.
November 5, 2007... CMS roundup Congress seen likely to cover cuts of '08 Part B doctors' fees By MARK McCARTY Medical Device Daily Washington Editor The sustainable growth rate (SGR) mechanism for controlling the increase in some parts of the...

Use of new polymer may lead to longer-lasting artificial joints.
November 5, 2007... A sub-clinical infection 'Ah-ha!' Use of new polymer may lead to longer-lasting artificial joints By ROB KIMBALL Medical Device Daily Staff Writer The classic, some might say stereotypical, image of a hip replacement patient...

Report from Europe.(CVRx, Collexis Holdings, SyynX Solutions, InSightec)
November 5, 2007... Report from Europe CVRx receives CE mark for its Rheos hypertension treatment A Medical Device Daily Staff Report CVRx (Minneapolis) has received CE-mark approval for its Rheos Baroreflex Hypertension Therapy System, which it said...

Opko Health licenses device to prevent endophthalmitis.
November 5, 2007... Opko Health licenses device to prevent endophthalmitis By KAREN YOUNG Medical Device Daily Staff Writer Opko Health (Miami), which includes in its portfolio a retinal imaging device and an ophthalmic drug in development, has now...

Court report.(Brief article)
November 5, 2007... Court report SEC charges insider trading by former Invitrogen scientist A Medical Device Daily Staff Report The U.S. Securities and Exchange Commission has filed charges alleging insider trading against a former scientist of...

Today's MDD food for med-tech thought.(Medical Device Daily, medical technology)(Brief article)
November 5, 2007... Today's MDD food for med-tech thought CMS "will continue to work with Congress and physician groups to identify payment methods that help improve the quality and efficiency of care in a way that is mindful to not increase costs to...

Deals roundup.(Cloud Packaging Solutions, Automated Packaging, Nature Clean Products)
November 5, 2007... Deals roundup Kensey Nash acquires license for optically guided guidewire A Medical Device Daily Staff Report Kensey Nash (Exton, Pennsylvania) reported that it has exclusively licensed a patent for Optical Coherence Domain...

Financings roundup.(Trivitron, ePlanet Ventures )
November 5, 2007... Financings roundup Trivitron receives $11 million for new med-tech park in India A Medical Device Daily Staff Report ePlanet Ventures (Silicon Valley, California) reported it has invested $11 million in Trivitron (Chennai, India)....

Briefly Noted.
November 5, 2007... Briefly Noted NAS receives Nasdaq letter North American Scientific (NAS; Chatsworth, California) said that it received a letter from the Nasdaq providing formal notice that the Nasdaq listing qualifications panel will consider the...

Agreements.
November 5, 2007... Agreements Sectra adds trauma templates from Synthes for orthopedics A Medical Device Daily Staff Report IT systems maker Sectra (Linkoping, Sweden) reported it will add trauma templates to its orthopedic product line-up as part of...

Product Briefs.(JHD Group)
November 5, 2007... Product Briefs * Amedica (Salt Lake City) said the FDA has granted 510(k) marketing clearance to Amedica's Valeo cervical plate system. The system is intended for anterior screw fixation at the C2 through C7 vertebral bodies of the...

People in Places.
November 5, 2007... People in Places * Advanced Cell Technology (ACT; Los Angeles) said that it has promoted Jonathan Dinsmore, PhD, as senior VP of regulatory and clinical and Ivan Wolkind to the position of senior VP of finance, administration and chief...

Got COURAGE? - yes, we do, and now also some sub-sets.
November 6, 2007... Stenting sometimes better, always more costly Got COURAGE? -- yes, we do, and now also some sub-sets By DON LONG Medical Device Daily Executive Editor ORLANDO -- Earlier this year, the man and woman on the street were told...

Deals roundup.
November 6, 2007... Deals roundup Swedish company to pay $750M for Boston Sci's surgery units A Medical Device Daily Staff Report A Swedish company said it would pay Boston Scientific (Natick, Massachusetts) $750 million in cash for its cardiac and...

Endoscopic capsules no longer a 'Given' market for pioneer.(Given Imaging, Jinshan Group, IntroMedic)
November 6, 2007... United European Gastroenterology Week Endoscopic capsules no longer a 'Given' market for pioneer By JOHN BROSKY Medical Device Daily European Editor PARIS -- The $100 million market for pill cameras is no longer a given for...

IT proliferation could change behaviors, impact of diseases.(information technology)
November 6, 2007... APHA Annual Meeting IT proliferation could change behaviors, impact of diseases By MARK McCARTY Medical Device Daily Washington Editor WASHINGTON -- The annual meeting of the American Public Health Association (APHA;...

Financings roundup.
November 6, 2007... Financings roundup Genoptix IPO nets $72.7 million; LabCorp in $500M share buyback A Medical Device Daily Staff Report Genoptix (Carlsbad, California) said it has closed its previously reported IPO of 5 million shares and that the...

Today's MDD food for med-tech thought.(Medical Device Daily, medical technology)(Brief article)
November 6, 2007... Today's MDD food for med-tech thought "If these results hold true, we may in the near future have the ability to reduce the risk of stroke by 90% in those PFO patients at greatest risk simply by evaluating this specific morphological...

Agreements roundup.
November 6, 2007... Agreements roundup ImaRx, Philips develop microbubble technology for ischemic stroke By LYNN YOFFEE Medical Device Daily Staff Writer ImaRx Therapeutics (Tucson, Arizona) and Royal Philips Electronics (Amsterdam, the...

Study findings may lead to lower stroke risk for PFO patients.(Clinical report)
November 6, 2007... AHA notebook Study findings may lead to lower stroke risk for PFO patients A Medical Device Daily Staff Report The presence of a tract, or separation, in the inner wall of the heart's atrial septum appears to be a strong predictor...

Patent Watch.
November 6, 2007... Patent Watch Vermillion to get $2M for SELDI technology patents A Medical Device Daily Staff Report Vermillion (Fremont, California) yesterday reported that the U.S. Patent and Trademark Office has issued a re-examination...

Grants/contracts.
November 6, 2007... Grants/contracts NIH grants Imalux $2.3M for early stage cancer screening A Medical Device Daily Staff Report Imalux (Cleveland), developer of the Niris Imaging System based on Optical Coherence Tomography (OCT) technology,...

Product Briefs.(Brief article)
November 6, 2007... Product Briefs * ArthroCare (Austin, Texas) reported the launch of Quantum, a platform for arthroscopic surgery that it said would provide surgeons with "the most advanced technology available to help improve clinical outcomes." The...

FDA will review Abbott's PMA for XIENCE V stent system.
November 6, 2007... FDA will review Abbott's PMA for XIENCE V stent system A Medical Device Daily Staff Report Abbott (Abbott Park, Illinois) said that the FDA has confirmed a circulatory systems devices advisory panel meeting on Nov. 29 to review the...

People in Places.
November 6, 2007... People in Places * Cardinal Health (Dublin, Ohio) said that Mark Parrish is stepping down as CEO of the company's Healthcare Supply Chain Services (HSCS) sector to pursue other interests. CFO Jeffrey Henderson will assume the additional...

Big study offers 'reassurance' to drug-eluting stent safety.
November 7, 2007... Moving from far better to 'no worse' Big study offers 'reassurance' to drug-eluting stent safety By DON LONG Medical Device Daily Executive Editor ORLANDO -- The game -- and the language -- concerning drug-eluting stent (DES)...

BioTime, Argonne form partnership for therapeutic hypothermia study.
November 7, 2007... BioTime, Argonne form partnership for therapeutic hypothermia study By OMAR FORD Medical Device Daily Staff Writer Some elements of therapeutic hypothermia seem reminiscent of something straight out of a B movie science fiction...

New endoscopes sharpen focus by a considerable magnitude.(Mauna Kea Technologies)(Editorial)
November 7, 2007... United European Gastroenterology Week New endoscopes sharpen focus by a considerable magnitude By JOHN BROSKY Medical Device Daily European Editor PARIS -- In a future visit to the doctor, a colored bar on a plastic strip may...

For-profit rehab hospitals said to be making good use of PPS.
November 7, 2007... APHA Annual Meeting For-profit rehab hospitals said to be making good use of PPS By MARK McCARTY Medical Device Daily Washington Editor WASHINGTON -- The financing of hospital operations has been a topic of especially intense...

Deals roundup.
November 7, 2007... Deals roundup Hansen buys AorTx for up to $40M; Greatbatch acquires EAC for $12M A Medical Device Daily Staff Report Hansen Medical (Mountain View, California) reported that it has signed a definitive agreement to acquire AorTx...

Today's MDD food for med-tech thought.
November 7, 2007... Today's MDD food for med-tech thought When he was offered the possible comparative analogies of a person being run over by a rickshaw or run over by a locomotive, Waksman said DES-stent thrombosis clearly is the "locomotive" of adverse...

Report from Europe.(Report)
November 7, 2007... Report from Europe Data cites use of Vermillion biomarkers in cancer study A Medical Device Daily Staff Reports Vermillion (Fremont, California) and its collaborators presented data demonstrating that several of the company's...

HeartMate II from Thoratec may help women with heart failure.
November 7, 2007... AHA notebook HeartMate II from Thoratec may help women with heart failure A Medical Device Daily Staff Report A small, implantable device that helps the heart pump blood offers the promise of keeping alive more women with advanced...

Court report.
November 7, 2007... Court report Judge dismisses part of J&J's suit against American Red Cross A Medical Device Daily Staff Report A U.S. federal judge dismissed a key part of a lawsuit brought by Johnson & Johnson (J&J; New Brunswick, New Jersey)...

Agreements roundup.
November 7, 2007... Agreements roundup Guardian, Delft partner to develop new TB-targeted imaging system A Medical Device Daily Staff Report Guardian Technologies International (Herndon, Virginia) is partnering with Delft Diagnostic Imaging...

Patent watch.(IVI Smart Technologies)
November 7, 2007... Patent watch Imaging Diagnostic Systems gets breast cancer tech from Chinese A Medical Device Daily Staff Report Imaging Diagnostic Systems (Fort Lauderdale; Florida) a developer of laser optical breast cancer imaging systems,...

Product Briefs.
November 7, 2007... Product Briefs * Affymetrix (Santa Clara, California) reported the full commercial launch of Affymetrix GeneChip command console (AGCC) software, one part of a software suite that enables researchers and clinicians to extract and analyze...

People in Places.
November 7, 2007... People in Places * Michael Seidenman has been named VP of sales of BioElectronics (Frederick, Maryland). Seidenman is a licensed pharmacist, a surgical appliance technician and is well-versed in electro medicine devices. BioElectronics...

Women still lagging in trials ... but gender a greater focus at big cardiovascular meeting.(clinical trials, American Heart Association )
November 8, 2007... Women still lagging in trials... ... but gender a greater focus at big cardiovascular meeting By DON LONG Medical Device Daily Executive Editor ORLANDO -- The past five years has seen increasing and much-needed focus on heart...

Deals roundup.
November 8, 2007... Deals roundup IMI closes $165M HemoSense buy; Zimmer buy of Orthosoft complete A Medical Device Daily Staff Report Inverness Medical Innovations (IMI; Waltham, Massachusetts) reported that it completed its $165 million acquisition...

Given Imaging seeks to open new market with PillCam Colon.
November 8, 2007... United European Gastroenterology Week Given Imaging seeks to open new market with PillCam Colon By JOHN BROSKY Medical Device Daily European Editor PARIS -- Physicians over the last three years have quickly adopted a...

CDC data confirm correlation between COPD, heart disease.
November 8, 2007... APHA Annual Meeting CDC data confirm correlation between COPD, heart disease By MARK McCARTY Medical Device Daily Washington Editor WASHINGTON -- Device makers know that heart disease is a growing area of concern, and so do...

Financings roundup.
November 8, 2007... Financings roundup BioForm prices IPO at $8 a share for up to $92 million in proceeds A Medical Device Daily Staff Report Medical aesthetics company BioForm Medical (San Mateo, California) reported the pricing of its previously...

Today's MDD food for med-tech thought.(Medical Device Daily, medical technology, Veterans Affairs Medical Center)(Brief article)
November 8, 2007... Today's MDD food for med-tech thought "It's fine to say everyone should have a colonoscopy. But we are talking about 70 million people. It is unclear whether that is even feasible in the U.S." -- John Bond, MD, chief of...

Washington roundup.
November 8, 2007... Washington roundup CMS to reimburse for freezing technique of cancer therapy A Medical Device Daily Staff Report The Centers for Medicare and Medicaid Services (CMS; Washington) has accepted the recommendation received from the...

Study delivers inconclusive data on test from Cambridge Heart.
November 8, 2007... AHA notebook Study delivers inconclusive data on test from Cambridge Heart A Medical Device Daily Staff Report A diagnostic test intended to identify patients who should receive heart defibrillators did not produce conclusive data,...

Agreements roundup.
November 8, 2007... Agreements roundup Beckman Coulter signs $94M supplier deal with MedAssets A Medical Device Daily Staff Report Beckman Coulter (Fullerton, California) reported that it has renewed agreements valued at about $94 million per year...

Patent watch.
November 8, 2007... Patent watch WellPoint and Katz licensing firm settle patent litigation A Medical Device Daily Staff Report Ronald A. Katz Technology Licensing (RAKTL; Los Angeles) and WellPoint (Indianapolis) reported settlement of patent...

Product Briefs.
November 8, 2007... Product Briefs * BioSphere Medical (Rockland, Massachusetts) said that the Centers for Medicare & Medicaid Services has issued its Final Rule regarding hospital outpatient reimbursement for uterine fibroid embolization (UFE) and,...

People in Places.(EmSense)(Brief article)
November 8, 2007... People in Places * Jeffrey Leathe was named CFO of BioTrove (Woburn, Massachusetts). Leathe previously was executive VP, CFO and treasurer for Apogent Technologies. BioTrove makes technology platforms. * Elissa Moses was named chief...

Itamar among surprising, non-invasive tech at meeting.(technology, American Heart Association meeting, Kent Scientific, Medispec)
November 9, 2007... Exhibiting innovation... ... Itamar among surprising, non-invasive tech at meeting By DON LONG Medical Device Daily Executive Editor ORLANDO -- Are the exhibition areas at these big conferences getting swankier, the exhibits...

Thoratec gets double bad news: IVAD recall and FDA warning.(implantable ventricular assist device, Food and Drug Administration)
November 9, 2007... Thoratec gets double bad news: IVAD recall and FDA warning By HOLLAND JOHNSON Medical Device Daily Managing Editor Thoratec (Pleasanton, California) reported a double dose of bad news just days after presentation of positive news...

International report.
November 9, 2007... International report Infectious disease pact signed by North American nations A Medical Device Daily Staff Report Health agencies from the U.S., Canada and Mexico agreed last week to strengthen cross-border coordination and...

'Intelligent' pills, active capsules to offer significant competition.
November 9, 2007... United European Gastroenterology Week 'Intelligent' pills, active capsules to offer significant competition By JOHN BROSKY Medical Device Daily European Editor PARIS -- The Millennium Research Group (Toronto) predicts that...

Court report.
November 9, 2007... Court report Suit: birth defects caused by clean room chemical exposure A Medical Device Daily Staff Report A lawsuit has been filed against Advanced Micro Devices (AMD; Austin, Texas) and a regional medical association that claims...