Medical Device Week articles from February 2007

Medical Device Week archives from February 2007

AF treatment: big opportunity but with many question marks.
February 1, 2007... The Society of Thoracic Surgeons 43rd Annual Meeting AF treatment: big opportunity but with many question marks By LARRY HAIMOVITCH Medical Device Daily Contributing Writer SAN DIEGO -- The 43rd annual meeting of the Society of...

Surgeon/industry ties: skewing judgment or stifling innovation?
February 1, 2007... The Society of Thoracic Surgeons 43rd Annual Meeting Surgeon/industry ties: skewing judgment or stifling innovation? By AMANDA PEDERSEN Medical Device Daily Staff Writer SAN DIEGO -- Not unlike most medical conferences, this...

Europe is struggling to build compatible e-health standards.
February 1, 2007... 2nd in a series Europe is struggling to build compatible e-health standards By JOHN BROSKY Medical Device Daily Contributing Writer E-health in Europe was quite literally all over the map at the end of 2006, with pockets of...

Xtent files for an amended IPO; Kyphon offers $350M in notes.
February 1, 2007... Xtent files for an amended IPO; Kyphon offers $350M in notes A Medical Device Daily Staff Report Xtent (Menlo Park, California) reported an amended filing with the Securities and Exchange Commission (SEC) for an initial public offering...

Agreements roundup.
February 1, 2007... Agreements roundup Symbion in three agreements for freestanding surgery centers A Medical Device Daily Staff Report Symbion (Nashville, Tennessee), owner and operator of short-stay surgical facilities, reported signing three...

Upcoming med-tech conferences.
February 1, 2007... Upcoming med-tech conferences * American Academy of Dermatology, Feb. 3-5, (Washington) www.aad.org * Stroke Nursing Symposium, Feb. 6, Moscone West Convention Center (San Francisco) ...

Financings roundup.
February 1, 2007... Financings roundup Quick Study Radiology garners $3.3 million in series D round A Medical Device Daily Staff Report Quick Study Radiology (QSR; St. Louis), a company bringing to smaller community hospitals the radiology services...

Atherotech reports restructuring, forms management committee.(Brief article)
February 1, 2007... Arthrotech reports restructuring, forms management committee A Medical Device Daily Staff Report Atherotech (Birmingham, Alabama), a developer of cardio-diagnostic technology, including its VAP cholesterol test, reported a series of...

Deals roundup.
February 1, 2007... Deals roundup Haemonetics buys IDM for $9M; Revolutions acquires Clear Image A Medical Device Daily Staff Report Haemonetics (Braintree, Massachusetts), a leader in blood collection technology, reported acquiring the assets of...

Briefly Noted.
February 1, 2007... Briefly Noted MRG report says PFO market 'hot' Millennium Research Group (Waltham, Massachusetts) has issued a report on Transcatheter Embolization and Occlusion markets in the U.S, saying that "the hottest market" is the patent...

Product Briefs.
February 1, 2007... Product Briefs * Cook Medical (Miami) reports that the Zilver PTX Paclitaxel-Eluting Stent (DES) trial results demonstrated no stent fractures. Cook said that the major adverse event rate was equivalent to conventional balloon angioplasty...

People in Places.
February 1, 2007... People in Places * James Esinhart, PhD, has been appointed global head of biometrics for Chiltern International (Carlsbad, California). Esinhart will be based in Wilmington, North Carolina and will be responsible for overseeing...

Possis gains FDA approval for Spiroflex rapid exchange catheter.
February 1, 2007... Possis gains FDA approval for Spiroflex rapid exchange catheter A Medical Device Daily Staff Report Possis Medical (Minneapolis) reports that it has received approval from the FDA to market its AngioJet Spiroflex rapid exchange catheter...

New devices of all sizes drew interest at STS exhibit booths.
February 2, 2007... Society of Thoracic Surgeons 43rd Annual Meeting New devices of all sizes drew interest at STS exhibit booths By AMANDA PEDERSEN Medical Device Daily Staff Writer SAN DIEGO -- Walking through the exhibit hall this week at the...

Underperformance for Med-tech stocks, but M&A to be robust.
February 2, 2007... Audioconference conclusions: Underperformance for Med-tech stocks, but M&A to be robust By KAREN YOUNG Medical Device Daily Staff Writer While stocks in medical devices, like pharmaceuticals, have underperformed the S&P 500...

Is Europe's IT infrastructure ready to make e-health work?
February 2, 2007... 3rd in a series Is Europe's IT infrastructure ready to make e-health work? By JOHN BROSKY Medical Device Daily Contributing Writer BRUSSELS -- The European Commission hailed a "significant start on the journey toward fully...

Deals roundup.
February 2, 2007... Deals roundup Quest buys HemoCue for $420M; Conor stakeholders OK merger A Medical Device Daily Staff Report Quest Diagnostics (Lyndhurst, New Jersey), a provider of diagnostic testing, information and services, reported that it...

Financings roundup.
February 2, 2007... Financings roundup Inverness underwriters exercise full 900K IPO over-allotment A Medical Device Daily Staff Report Inverness Medical Innovations (Waltham, Massachusetts) reported that underwriters exercised their over-allotment...

Washington roundup.
February 2, 2007... Washington roundup Rural hospitals outshine city counterparts in P4P numbers By MARK McCARTY Medical Device Daily Washington Editor WASHINGTON -- The pay-for-performance (P4P) project continues to offer impressive numbers, and...

Grants/contracts.
February 2, 2007... Grants/contracts DR Systems reports RIS/PACS awards of more than $7.4M A Medical Device Daily Staff Report DR Systems (San Diego), makers of the Unity RIS/PACS system, reported 12 new contracts with healthcare facilities -- ranging...

Briefly Noted.
February 2, 2007... Briefly Noted Cardinal says gloves meet new FDA regs Cardinal Health (Dublin, Ohio), a provider of products and services supporting the health-care industry, reported the medical gloves it manufactures already meet or exceed new...

Product Briefs.
February 2, 2007... Product Briefs * American Bio Medica (Kinderhook, New York) reported the launch of the patent pending OralStat EX, an oral fluid point-of-collection test that improves the limits of detection over other point-of-collection oral fluid drug...

People in Places.(CryoCor appointments)(Brief article)
February 2, 2007... People in Places * CryoCor (San Diego) has added three new medical advisors who specialize in the treatment of atrial fibrillation. The new advisors are Drs. Hugh Calkins, director of electrophysiology at Johns Hopkins University; Mark...

Washington roundup.
February 5, 2007... Washington roundup HHS's HIT standards may not control for all OS compatibility By MARK McCARTY Medical Device Daily Washington Editor WASHINGTON -- Healthcare information technology, or HIT as it is affectionately known,...

AST is targeting "neutral zone" for stabilization of aching spine.
February 5, 2007... AST is targeting 'neutral zone' for stabilization of aching spine By ROB KIMBALL Medical Device Daily Staff Writer The majority of the 30 million U.S. patients who report back pain each year usually resolve the problem with...

Report from Europe.
February 5, 2007... Report from Europe Molnlycke Health Care bought in deal valued at $3.6 billion By JOHN BROSKY Medical Device Daily Contributing Writer And MDD Staff Reports Mölnlycke Health Care (Stockholm, Sweden), a major provider...

Electro-Optical in pivotal trial with MelaFind for melanoma.
February 5, 2007... Electro-Optical in pivotal trial with MelaFind for melanoma By KAREN YOUNG Medical Device Daily Staff Writer With melanoma rates on the rise -- and the prognosis for the disease poor unless detected early -- Electro Optical...

Deals roundup.
February 5, 2007... Deals roundup J&J completes $1.4B Conor buy; Inverness acquires Promesan A Medical Device Daily Staff Report Johnson & Johnson (J&J; New Brunswick, New Jersey) reported that it has consummated its $1.4 billion acquisition of Conor...

Financings roundup.
February 5, 2007... Financings roundup BioDx secures $8.5M 'A' round; Precision Optics raises $2.5M A Medical Device Daily Staff Report BioBehavioral Diagnostics (BioBDx; Cambridge, Massachusetts) reported securing an $8.5 million Series A financing,...

Grants/contracts.
February 5, 2007... Grants/contracts Kindred inks agreement to lease nursing facilities from Ocadian A Medical Device Daily Staff Report Kindred Healthcare (Louisville, Kentucky) reported that its subsidiaries have signed a contract to lease eight...

Briefly Noted.
February 5, 2007... Briefly Noted pSivida's Retisert given specific J-code Global bio-nanotech company pSivida (Perth, Australia) said that Retisert, developed jointly by pSivida and Bausch & Lomb (B&L; Rochester, New York) has been allocated a product...

CMS set to expand coverage for carotid artery stents.
February 5, 2007... CMS set to expand coverage for carotid artery stents A Medical Device Daily Staff Report The Centers for Medicare & Medicaid Services (CMS) reported that it is proposing to expand its coverage policy for carotid artery stenting (CAS)....

Product Briefs.
February 5, 2007... Product Briefs * Cynosure (Westford, Massachusetts) reported the addition of a new 1320 nm wavelength laser for its flagship Affirm workstation, a solution for anti-aging applications, including skin rejuvenation, treatments for wrinkles,...

People in Places.
February 5, 2007... People in Places * Laura Weller-Brophy was named biomedical product development and commercialization manager of Infotonics Technology Center (Cherry Hill, New Jersey). Brophy will focus her efforts on bringing to market optical...

Device makers see dollar signs in proposal for CAS expansion.
February 6, 2007... Device makers see dollar signs in proposal for CAS expansion BY HOLLAND JOHNSON Medical Device Daily Managing Editor In the wake of the proposed National Coverage Decision for expanded use of carotid artery stenting (CAS), issued...

Financings roundup.
February 6, 2007... Financings roundup Applied Digital plans to spin off VeriChip unit via 4.3M-share IPO By HOLLAND JOHNSON Medical Device Daily Managing Editor Applied Digital Solutions (Delray Beach, Florida), a maker of identification and...

Report from Europe.(German healthcare reform)(Medicsight changes name to MGT Capital Investment)(UK National Health Service rule on personal injury compensation)
February 6, 2007... Report from Europe Healthcare reform in Germany now set to take effect April 1 By JOHN BROSKY Medical Device Daily Contributing Writer And MDD Staff Reports Healthcare reform is on the way in Germany following last...

<i>The Lancet</i> publishes Ravgen research on prenatal testing.
February 6, 2007... The Lancet publishes Ravgen research on prenatal testing By KAREN YOUNG Medical Device Daily Staff Writer Study publication in The Lancet brings with it significant cachet. And Ravgen (Columbia, Maryland), privately held, can make...

Court report.
February 6, 2007... Court report Durus founder Sacane faces three-year prison sentence A Medical Device Daily Staff Report The Securities and Exchange Commission on Friday reported that a Connecticut federal judge has sentenced Scott Sacane, the...

Deals roundup.
February 6, 2007... Deals roundup Inverness will pay $25M in cash to buy First Check Diagnostics A Medical Device Daily Staff Report Inverness Medical Innovations (Waltham, Massachusetts), a manufacturer of rapid diagnostic products, reported...

Agreements roundup.(Clinical report)
February 6, 2007... Agreements roundup Algynomics, Orthogen in pact to study orthopedics medicine A Medical Device Daily Staff Report Algynomics (Chapel Hill, North Carolina) and Orthogen (Dusseldorf, Germany) reported forming an alliance in the area...

Briefly Noted.
February 6, 2007... Briefly Noted Tyco Healthcare to be named Covidien Tyco Healthcare (Mansfield, Massachusetts) said that its new name will be Covidien, once the global healthcare company separates from parent Tyco International (Pembroke, Bermuda) this...

Product Briefs.
February 6, 2007... Product Briefs * Alcon Laboratories (Fort Worth, Texas) reported that the FDA has granted approval of the AcrySof ReSTOR apodized diffractive aspheric intraocular lens for the visual correction of aphakia following cataract surgery in...

People in Places.
February 6, 2007... People in Places * Dennis Bucceri has been named senior VP of regulatory affairs for Acusphere (Watertown, Massachusetts), the hire made, Acusphere said, as it prepares for regulatory evaluation stage of its lead product candidate,...

Washington roundup.
February 7, 2007... Washington roundup White House budget proposed as 'aggressive,' 'responsible' By MARK McCARTY Medical Device Daily Washington Editor WASHINGTON -- The White House published its proposed budget for fiscal 2008 this past...

CMS refutes WSJ article claiming imminent review of DES coverage.(Wall Street Journal article on possible Medicare restrictions on drug eluting stents)
February 7, 2007... CMS refutes WSJ article claiming imminent review of DES coverage By HOLLAND JOHNSON Medical Device Daily Managing Editor Skittish investors, already spooked over the past year by recent chinks in the drug-eluting stent (DES)...

Report from Europe.
February 7, 2007... Report from Europe Study cites Ablatherm success vs. high-risk prostate cancer A Medical Device Daily Staff Report EDAP TMS (Lyon, France) said a recent publication outlined successful results achieved in an Italian study of 30 men...

FDA clears test to predict the recurrence of breast cancer.
February 7, 2007... FDA clears test to predict the recurrence of breast cancer By AMANDA PEDERSEN Medical Device Daily Staff Writer The FDA yesterday reported marketing clearance for a new genetic test used to determine the likelihood of breast cancer...

CMS poised to reject VNS from Cyberonics to treat depression.
February 7, 2007... Another setback CMS poised to reject VNS from Cyberonics to treat depression By DON LONG Medical Device Daily Executive Editor Cyberonics (Houston), already dealing with a variety of negatives, was hit with more bad news this...

Financings roundup.
February 7, 2007... Financings roundup Accuray IPO seeking $99.5M; Invacare prices $125M in notes By DON LONG Medical Device Daily Executive Editor And MDD Staff Reports Accuray (Sunnyvale, California), maker of the CyberKnife radiosurgery...

Deals roundup.
February 7, 2007... Deals roundup CardioNet to acquire PDSHeart; Bio-Imaging Tech buys Theralys A Medical Device Daily Staff Report CardioNet (San Diego), a provider of wireless mobile cardiac outpatient monitoring solutions, reported that it has...

Grants/contracts.
February 7, 2007... Grants/contracts Johns Hopkins Hospital to use HealthMatics ED from Allscripts A Medical Device Daily Staff Report Allscripts (Chicago), a provider of clinical software, healthcare connectivity and information solutions, reported...

Agreements roundup.
February 7, 2007... Agreements roundup Cardinal, FDA develop process for return of Alaris SE pumps A Medical Device Daily Staff Report Cardinal Health (Dublin, Ohio) reported reaching an agreement with the FDA on a consent decree regarding its Alaris...

Briefly Noted.
February 7, 2007... Briefly Noted ThermoGenesis answers FDA questions ThermoGenesis (Rancho Cordova, California) reported that the company has responded to the FDA's questions on its pre-market approval (PMA) application for its CryoSeal Fibrin Sealant...

Abbott to initiate women-only trial to assess performance of DES.
February 7, 2007... Abbott to initiate women-only trial to assess performance of DES A Medical Device Daily Staff Report Abbott (Abbott Park, Illinois) yesterday said it will initiate the world's first drug-eluting stent (DES) clinical trial for DES use...

Response reports succession plan, president/CEO steps down.(Response Biomedical)(Brief article)
February 7, 2007... Response reports succession plan, president/CEO steps down A Medical Device Daily Staff Report As part of a succession plan, Bill Radvak, president/CEO of Response Biomedical (Vancouver, British Columbia), said he will step down from...

Product Briefs.
February 7, 2007... Product Briefs * Health Discovery (Savannah, Georgia) reported that it has filed new patent applications in the United States Patent and Trademark Office and in the U.S. Receiving Office for the Patent Cooperation Treaty for U.S. and...

People in Places.
February 7, 2007... People in Places * Bob Elson, MD, has joined Eclipsys (Boca Raton, Florida) as chief medical officer. Former Eclipsys CMO, Diane Bradley, MD, now serves as the chief quality and outcomes officer. Eclipsys is a provider of advanced...

Mammography clinics get three years between accreditations.
February 8, 2007... Mammography clinics get three years between accreditations By MARK McCARTY Medical Device Daily Washington Editor Those who handle regulatory affairs in most of the industries under the FDA's purview would celebrate a decrease in...

Deals roundup.
February 8, 2007... Deals roundup China Medical to acquire FISH technology for up to $177M By HOLLAND JOHNSON Medical Device Daily Managing Editor China Medical Technologies (Beijing), a manufacturer of ultrasound products and in vitro...

International report.
February 8, 2007... International report Washington program focuses on China's growth in nanotech A Medical Device Daily Staff Report An event held in Washington earlier this week focused on China's current and future capabilities to become a leading...

Fujirebio's test for monitoring mesothelioma FDA-approved.
February 8, 2007... Fujirebio's test for monitoring mesothelioma FDA-approved By KAREN YOUNG Medical Device Daily Staff Writer Mesothelioma, a form of cancer caused by exposure to asbestos, may not be the most common form of cancer, but it is highly...

Agreements.
February 8, 2007... Agreements MedicAlert's RFID application in student health records test A Medical Device Daily Staff Report MedicAlert (Turlock, California), a provider of emergency information services and personal health records, said that it...

Financings roundup.
February 8, 2007... Financings roundup Kyphon closes $300M note sale; Bruker BioSciences prices offer A Medical Device Daily Staff Report Kyphon (Sunnyvale, California) reported the closing of its offering of $200 million aggregate principal amount of...

Court report.
February 8, 2007... Court report Appeals court: BrainLab not infringing Medtronic patents A Medical Device Daily Staff Report Medtronic (Minneapolis) has lost its appeals court bid to revive a $51 million jury verdict against BrainLab (Munich,...

Briefly Noted.
February 8, 2007... Briefly Noted CMS raises reimbursement for ECP therapy ScottCare (Cleveland) reported that the Centers for Medicare and Medicaid Services has significantly increased reimbursement levels for external counterpulsation (ECP) therapy,...

Product Briefs.
February 8, 2007... Product Briefs * Artes Medical (San Diego) reported its first shipment of ArteFill to trained physicians. Artes says that ArteFill is "the first and only non-resorbable injectable filler for the correction of wrinkles, or nasolabial folds...

People in Places.
February 8, 2007... People in Places * Stephen Osbaldeston has been named CEO of Ophthonix (San Diego). Osbaldeston was most recent president, Global Specialty Lens and Lens Care at Ciba Vision. Ophthonix manufactures vision assessment and correction...

Alveolus rolls out Aero Hybrid Tracheobronchial Stent System.
February 8, 2007... Alveolus rolls out Aero Hybrid Tracheobronchial Stent System A Medical Device Daily Staff Report Alveolus (Charlotte, North Carolina), a provider of non-vascular interventional stent technology, has launched its Aero Hybrid...

Staar sees delay in approval of implantable lens for astigmatism.
February 9, 2007... Staar sees delay in approval of implantable lens for astigmatism By AMANDA PEDERSEN Medical Device Daily Staff Writer Ophthalmic product maker Staar Surgical (Monrovia, California) said earlier this week that federal regulators are...

Financings roundup.
February 9, 2007... Financings roundup Accuray raises IPO price to $18, sees shares surge more than 58% By HOLLAND JOHNSON Medical Device Daily Managing Editor Accuray (Sunnyvale, California), maker of the CyberKnife radiosurgery system, appears...

Report from Europe.
February 9, 2007... Report from Europe Legislative backing seen for EDC/EHR convergence push A Medical Device Daily Staff Report A favorable legislative environment supporting improved accessibility to patient data is encouraging the use of IT and...

Tuesday audio conference eyes coronary stent clinical issues.
February 9, 2007... Tuesday audio conference eyes coronary stent clinical issues AHC Media, the publisher of Medical Device Daily, is presenting an interactive audio conference on Tuesday, Feb. 13, on "Unblocking the Truth About Coronary Stents." The session...

Deals roundup.
February 9, 2007... Deals roundup Coratus to merge with VIA; APND licenses molecular beacons By HOLLAND JOHNSON Medical Device Daily Managing Editor Making good on its promise last month to merge with another company, Corautus Genetics (Atlanta)...

Grants/contracts.
February 9, 2007... Grants/contracts Stryker to sell Swissray DR systems; CSC to transform IT at Red Cross A Medical Device Daily Staff Report Swissray (Elizabeth, New Jersey), a manufacturer in the direct digital radiographic systems industry,...

Court report.
February 9, 2007... Court report Celsion to license American Medical IP to settle patent dispute A Medical Device Daily Staff Report American Medical Systems (AMS; Minnetonka, Minnesota) reported that it has entered into a settlement and licensing...

Agreements roundup.
February 9, 2007... Agreements roundup American Bio Medica in purchase agreement with clinical lab A Medical Device Daily Staff Report American Bio Medica (ABMC; Kinderhook, New York) reported that it has entered into a purchase agreement with one of...

Briefly Noted.
February 9, 2007... Briefly Noted Mayo proposes lung surgery indicators Mayo Clinic (Rochester, Minnesota) surgeons have proposed a system of lung surgery quality indicators for surgeons and the public as a method to demonstrate best practices for...

People in Places.
February 9, 2007... People in Places * Joseph Paiva has been promoted to chief business officer of Orthovita (Malvern, Pennsylvania). Paiva was the CFO from joining the company in 1997. Albert Pavucek was concurrently named Orthovita's CFO. Pavucek joined...

Product Briefs.
February 9, 2007... Product Briefs * Arrow International (Reading, Pennsylvania) reports that it is upgrading the majority of its U.S.-distributed central venous access kits to include Hi-Lite Orange tinted ChloraPrep. Hi-Lite Orange tinted ChloraPrep...

FDA to push ahead with assay guidance despite opposition.
February 12, 2007... FDA to push ahead with assay guidance despite opposition By MARK McCARTY Medical Device Daily Washington Editor GAITHERSBURG, Maryland -- Makers of in vitro diagnostics for in-house use have faced little FDA oversight in the past,...

Somnoscreen reduces tethering for better sleep in a sleep lab.
February 12, 2007... Somnoscreen reduces tethering for better sleep in a sleep lab By DON LONG Medical Device Daily Executive Editor Sleep labs aren't particularly easy places to get a good night's sleep in, says Allan Brack, VP of sales for the...

International report.
February 12, 2007... International report eGene in bird flu screening agreement with Singapore firm A Medical Device Daily Staff Report eGene (Irvine, California), developer of genetic analysis technology, said it plans to launch a "complete solution...

Last call for audio conference on coronary stent issues.
February 12, 2007... Last call for audio conference on coronary stent issues There's still time -- but not much -- to register for a Medical Device Daily-sponsored interactive audio conference on "Unblocking the Truth About Coronary Stents. " The program,...