Medical Device Week articles from February 2006

Medical Device Week archives from February 2006

Advanced imaging points to even better care on horizon.
February 1, 2006... Advanced imaging points to even better care on horizon By AARON LORENZO Medical Device Daily Washington Writer WASHINGTON -- The field of medical diagnostics has come a long way since the advent of X-rays more than a century ago....

LDR Spine gets IDE for first multi-level cervical disc trial.
February 1, 2006... LDR Spine gets IDE for first multi-level cervical disc trial By HOLLAND JOHNSON Medical Device Daily Associate Managing Editor LDR Spine (Austin, Texas) reported that it obtained approval for an investigational device exemption...

Report from Europe.
February 1, 2006... Report from Europe Asian manufacturing a concern, opportunity for European firms A Medical Device Daily Staff Report The growing emergence of Asia as a low-cost region for medical device manufacturing is a source of concern for...

ThermoGenesis in $30.1M offer; Somanetics to sell 2.1M shares.
February 1, 2006... ThermoGenesis in $30.1M offer; Somanetics to sell 2.1M shares A Medical Device Daily Staff Report ThermoGenesis (Rancho Cordova, California) reported that it has priced a public offering of 8 million shares of its common stock at $4 a...

Court report.(Vascular Solutions, Diomed both claim wins in litigation)
February 1, 2006... Court report Vascular Solutions, Diomed both claim wins in litigation A Medical Device Daily Staff Report Vascular Solutions (VSI; Minneapolis) and Diomed (Andover, Massachusetts) both issued statements finding positives in a...

McCormick Place showcases new, flagship cardio products.
February 1, 2006... Society of Thoracic Surgeons McCormick Place showcases new, flagship cardio products A Medical Device Daily Staff Report Though not providing a broad array of new clinical trial data, the annual meeting of the Society of Thoracic...

Financings roundup.
February 1, 2006... Financings roundup Iomai shrinks its IPO by 44%; Cytori gets $11M milestone A Medical Device Daily Staff Report Iomai (Gaithersburg, Maryland), a developer of drugs and vaccines delivered via patch technology, has reduced by about...

Deals roundup.
February 1, 2006... Deals roundup Digitas completes MBC buy; Dominion/J. Bolen Group in j-v A Medical Device Daily Staff Report Digitas (Boston) said that it has completed the acquisition of Medical Broadcasting Co. (MBC; Philadelphia), one of the...

Grants/contracts.
February 1, 2006... Grants/contracts Xradia receives $1.4M NIH grant for X-ray microscope A Medical Device Daily Staff Report Xradia (Concord, California), a developer and manufacturer of ultra-high-resolution X-ray imaging systems for 3-D tomography...

Mixonix changes accounting firm.
February 1, 2006... Mixonix changes accounting firm Misonix (Farmingdale, New York), a developer of ultrasonic medical device systems to treat cancer and other conditions, said that its audit committee has retained Grant Thornton as its independent public...

Ciphergen in compliance with Nasdaq.
February 1, 2006... Ciphergen in compliance with Nasdaq Ciphergen Biosystems (Fremont, California) said that Nasdaq has informed it that it has evidenced compliance with the requirements for continued listing and that the "E" appended to the company's ticker...

Briefly Noted.(BriteSmile to appeal Nasdaq delisting notice )(FCC provides implant waiver to DexCom)
February 1, 2006... Briefly Noted BriteSmile to appeal Nasdaq delisting notice BriteSmile (Walnut Creek, California), a provider of teeth-whitening systems, said it has received a notice from the staff of the Nasdaq Stock Market saying that the company's...

Product Briefs.
February 1, 2006... Product Briefs * Collagen Matrix (Franklin Lakes, New Jersey) said it has received FDA 510(k) clearance of its Collagen-Mineral Composite Bone Graft Material for use in orthopedic-spine applications involving bone repair. The...

People in Places.(appointments)
February 1, 2006... People in Places * Hanger Orthopedic Group (Bethesda, Maryland) named Jeff Martin president of its wholly owned subsidiary, Innovative Neurotronics (IN). Previously serving as vice president and managing director of IN since its inception...

Neurologist says long-term data needed on PFO migraine 'cure'.
February 2, 2006... Neurologist says long-term data needed on PFO migraine 'cure' By HOLLAND JOHNSON Medical Device Daily Associate Managing Editor While there certainly is excitement among patients, doctors and investors about the potential for...

$745M Angiotech buy of AMI is 'last piece of the puzzle'.
February 2, 2006... $745M Angiotech buy of AMI is 'last piece of the puzzle' By DON LONG Medical Device Daily Managing Editor Continuing a strong push into the device realm -- and thereby further expanding its opportunities for innovative device/drug...

Report from Israel.
February 2, 2006... Report from Israel Reimbursement seen key for Israeli firms in U.S. market By RAE FISHMAN Medical Device Daily Contributing Writer ZICHRON YAAKOV, Israel -- Medical devices continue to lead Israel's life sciences subsector,...

Kos, others looking to deliver insulin via an inhaler system.
February 2, 2006... Kos, others looking to deliver insulin via an inhaler system By KAREN YOUNG Medical Device Daily Staff Writer On the heels of Pfizer's (New York) FDA approval last Friday of Exubera, an inhaled insulin product delivered via a...

Hospira to close or phase out 3 plants, reduce force by 10%.
February 2, 2006... Hospira to close or phase out 3 plants, reduce force by 10% A Medical Device Daily Staff Report Hospital products manufacturer Hospira (Lake Forest, Illinois) yesterday disclosed plans to close two manufacturing plants and phase out...

Uroplasty procedure covered by new payers.(Brief Article)
February 2, 2006... Uroplasty procedure covered by new payers Uroplasty (Minneapolis) reported two new decisions by payers to cover Percutaneous Tibial Nerve Stimulation (PTNS) therapies. Blue Cross Blue Shield of Minnesota and Blue Cross Blue Shield of...

Grants/contracts.
February 2, 2006... Grants/contracts U. of Pittsburgh, CombineNet form CombineMed joint venture A Medical Device Daily Staff Report The University of Pittsburgh Medical Center (UPMC; Pittsburgh) and CombineNet (also Pittsburgh) have formed a joint...

Aksys, Fusion Capital amend agreement.(Brief Article)
February 2, 2006... Aksys, Fusion Capital amend agreement Aksys (Lincolnshire, Illinois) said it has received a determination from the Nasdaq that the common stock purchase agreement the company executed on Jan. 13 violated Nasdaq's shareholder approval rules....

Financings roundup.(InnoCentive reports )(Brief Article)
February 2, 2006... Financings roundup InnoCentive reports closing a $9 million Series A round A Medical Device Daily Staff Report InnoCentive (Andover, Massachusetts) said it has closed a $9 million Series A preferred venture capital financing round...

Deals roundup.(Company Profile)
February 2, 2006... Deals roundup AmeriPath completes merger with Specialty Laboratories A Medical Device Daily Staff Report AmeriPath (Palm Beach Gardens, Florida), a provider of anatomic pathology, dermatopathology and molecular diagnostics, and...

Sigma-Aldrich business forms new Supply Solutions unit.
February 2, 2006... Sigma-Aldrich business forms new Supply Solutions unit A Medical Device Daily Staff Report SAFC, a member of the Sigma-Aldrich Group (both St. Louis), reported formation of a new entity, SAFC Supply Solutions, combining its Specialties...

Court report.
February 2, 2006... Court report Sontra warns Dermisonics on potential patent infringement A Medical Device Daily Staff Report Sontra Medical (Franklin, Massachusetts) reported that it has sent a notice to Dermisonics (West Conshohocken,...

Agreements roundup.
February 2, 2006... Agreements roundup CTA in distribution pact with South African firm SIMpill A Medical Device Daily Staff Report Clinical Technology Advisors (CTA; Boston), a provider of medication adherence and patient compliance solutions, and...

Briefly Noted.
February 2, 2006... Briefly Noted TUVHS cites progress in application Healthcare quality firm TUV Healthcare Specialists (TUVHS; Cincinnati) said that its application to the Centers for Medicare & Medicaid Services (CMS; Baltimore) for deeming authority...

Steris to move some manufacturing to Mexico.(Brief Article)
February 2, 2006... Steris to move some manufacturing to Mexico Steris (Mentor, Ohio), focused on infection prevention, decontamination and health science technologies, products and services, reported that the company is transferring the manufacturing portion...

Product Briefs.(3M Health Care launches Tegaderm Ag Mesh Dressing)(Agilent Technologies introduces chromatography-based mass spectrometry systems)(Cordis results on Cypher Sirolimus-Eluting Coronary Stunt)
February 2, 2006... Product Briefs * 3M Health Care (St. Paul, Minnesota) reported the launch of 3M Tegaderm Ag Mesh Dressing with Silver, a new wound care product with fast-acting, long-lasting antimicrobial barrier effectiveness against a range of microbes,...

People in Places.
February 2, 2006... People in Places * Michael Branca, vice president, finance and chief financial officer of MTS Medication Technologies (St. Petersburg, Florida), said he would resign those posts effective March 17 to return to a position in the private...

Haemacure gets warning letter, begins remedying deficiencies.
February 2, 2006... Haemacure gets warning letter, begins remedying deficiencies A Medical Device Daily Staff Report Haemacure (Montreal) reported receiving a warning letter from the FDA citing what it called "certain document deficiencies" relating to...

Physician specialists board offers disaster certification.
February 3, 2006... Physician specialists board offers disaster certification By KAREN YOUNG Medical Device Daily Staff Writer The American Board of Physician Specialists (ABPS; Atlanta) has organized what it said will be -- "for the first time in the...

Medtronic cites 1st implants of wireless CRT-D system.
February 3, 2006... Medtronic cites 1st implants of wireless CRT-D system By HOLLAND JOHNSON Medical Device Daily Associate Managing Editor A potentially revolutionary new feature may soon be added to Medtronic's cardiac resynchronization therapy...

Report from Europe.
February 3, 2006... Report from Europe Better prospects for more repair of DNA modulation By SHARON KINGMAN Medical Device Daily Contributing Writer and Staff Reports The discovery of a key molecule in the DNA repair pathway could hasten the...

Mako in licensing accord with U. of Florida for 'Material X'.
February 3, 2006... Mako in licensing accord with U. of Florida for 'Material X' By DON LONG Medical Device Daily Managing Editor Mako Surgical (Hollywood, Florida), an orthopedic technology company, said it has signed a licensing agreement with the...

Financings roundup.
February 3, 2006... Financings roundup Stereotaxis nets $62 million; Ekips gets $2.9M in funds A Medical Device Daily Staff Report Stereotaxis (St. Louis) reported the closing of its previously disclosed offering (Medical Device Daily, Jan. 30, 2006)...

Uroplasty moving to Minneapolis suburb.(Brief article)
February 3, 2006... Uroplasty moving to Minneapolis suburb Uroplasty (Minneapolis) reported plans to relocate its headquarters to the Minneapolis suburb of Minnetonka. The eight-year lease for the facility, at 5420 Feltl Rd., begins May 1. Uroplasty said the...

Court report.
February 3, 2006... Court report Sofamor Danek sues Biomet; Immucor director disgorges A Medical Device Daily Staff Report Medtronic (Minneapolis) reported that its spinal business, Medtronic Sofamor Danek (Memphis, Tennessee), has filed suit against...

Agreements.
February 3, 2006... Agreements Zyvex and Diabetech in pact for glucose nanobiosensor implant A Medical Device Daily Staff Report Zyvex (Richardson, Texas), a molecular nanotechnology company specializing in micro and nanomanufacturing,...

Deals roundup.
February 3, 2006... Deals roundup PainCare adds Amphora stake; Arcadia in Remedy acquisition A Medical Device Daily Staff Report PainCare Holdings (Orlando, Florida), a provider of high-tech pain relief services, reported the acquisition of 60% of the...

Briefly Noted.
February 3, 2006... Briefly Noted Harris Survey: most don't get second opinion A new survey from Harris Interactive (Rochester, New York) for the PBS health series Second Opinion, says that more than one in three adults (36%) in the U.S. never get a...

People in Places.(appointments)
February 3, 2006... People in Places * Gregory Hare has joined Guardian Technologies International (Herndon, Virginia) as CFO. He replaces Bill Donovan, who recently was appointed Guardian's president and chief operating officer. From May 2001 until last...

Product Briefs.(Brief article)
February 3, 2006... Product Briefs * Merge eMed (Milwaukee), a Merge Healthcare company providing healthcare software and services, reported that it has released Fusion Matrix PACS (picture archiving and communications system), version 2.1. The company said...

Christopher White is named general counsel of AdvaMed.
February 3, 2006... Christopher White is named general counsel of AdvaMed A Medical Device Daily Staff Report The Advanced Medical Technology Association (AdvaMed; Washington) has tapped Christopher White, an attorney with more than 15 years experience in...

CryoCor's atrial flutter PMA said 'not approvable' by FDA.
February 6, 2006... Company cites 'subjective' interpretation CryoCor's atrial flutter PMA said 'not approvable' by FDA By DON LONG Medical Device Daily Managing Editor Despite what it considered as signals that its premarket application for use...

Results of new studies appear to bolster use of Cypher DES.
February 6, 2006... Results of new studies appear to bolster use of Cypher DES By HOLLAND JOHNSON Medical Device Daily Associate Managing Editor Data from two recently released studies appears to offer more evidence of the benefits of Cordis' (Miami...

International report.(Medicsight's (London))(Portland Orthopaedics (Sydney, Australia))(MedAire to sell Asian Global Doctor clinics)(Company Profile)
February 6, 2006... International report Medicsight plans 8 clinical studies of software in Japan A Medical Device Daily Staff Report Medicsight's (London) majority owned Japanese subsidiary, Medicsight KK (Tokyo), said it plans to initiate eight...

Financings roundup.
February 6, 2006... Financings roundup Cardica is first device firm to test the 2006 IPO waters By DON LONG Medical Device Daily Managing Editor Cardiovascular products manufacturer Cardica (Redwood City, California) is the first pure device...

Deals roundup.
February 6, 2006... Deals roundup IT buys Accu-Stat Diagnostics; Cambrex to acquire Cutanogen A Medical Device Daily Staff Report Instant Technologies (IT; Norfolk, Virginia) reported that it has acquired Accu-Stat Diagnostics (Lake Forest,...

Commentary: Patchwork of proposals can't produce healthcare 'reform'.
February 6, 2006... Commentary Patchwork of proposals can't produce healthcare 'reform' By DON LONG Medical Device Daily Managing Editor Given the advance publicity indicating a heavy focus on healthcare in President George Bush's State of the...

Grants/contracts.
February 6, 2006... Grants/contracts Masimo signs three-year pact with Novation for oximetry A Medical Device Daily Staff Report Masimo (Irvine, California) said that it has signed a three-year, dual-source agreement with Novation (Irving, Texas), the...

Baxter complies with ongoing Colleague infusion pump recall.
February 6, 2006... Baxter complies with ongoing Colleague infusion pump recall A Medical Device Daily Staff Report Baxter Healthcare (Deerfield, Illinois) said it has acknowledged a recall classification by the FDA for drug infusion pumps to comply...

Briefly Noted.(BioDelivery engages branding firm)(Brief article)
February 6, 2006... Briefly Noted BioDelivery engages branding firm BioDelivery Sciences International (BDSI; Morrisville, North Carolina) reported that it has engaged Addison Whitney (Charlotte, North Carolina) to develop the brand identity and brand...

Hanger names management team for Innovative Neurotronics.(Hanger Orthopedic Group )
February 6, 2006... Hanger names management team for Innovative Neurotronics A Medical Device Daily Staff Report Hanger Orthopedic Group (Bethesda, Maryland) reported a new management team, led by President Jeff Martin, for its wholly owned subsidiary,...

People in Places.
February 6, 2006... People in Places * Allergan (Irvine, California) named F. Michael Ball president and Raymond Diradoorian executive vice president, global technical operations. David Pyott will maintain his position as Allergan's CEO and chairman of the...

Product Briefs.
February 6, 2006... Product Briefs * Diomed Holdings (Andover, Massachusetts), maker of the EndoVenous Laser Treatment (EVLT) for varicose veins, reported the launch of its next-generation EVLT procedure kit. The kit features the Spotlight sheath and...

OccuLogix's MIRA-1 for visual acuity judged not significant.(Brief article)
February 6, 2006... OccuLogix's MIRA-1 for visual acuity judged not significant A Medical Device Daily Staff Report Eye care services company TLCVision (St. Louis) reported that OccuLogix (Toronto), of which TLCVision has 51% ownership, has completed a...

CDC develops rapid test to detect H5 strain of avian flu.
February 7, 2006... CDC develops rapid test to detect H5 strain of avian flu By KAREN YOUNG Medical Device Daily Staff Writer The FDA late last week reported the approval of a new laboratory test, developed by the Centers for Disease Control and...

FDA shutters BTS operations for 'manufacturing deficiencies'.
February 7, 2006... FDA shutters BTS operations for 'manufacturing deficiencies' By HOLLAND JOHNSON Medical Device Daily Associate Managing Editor Under its comprehensive framework for ensuring the safety of human tissue products, the FDA has ordered...

Report from Europe.
February 7, 2006... Report from Europe German reimbursement, French approval for Abiomed devices A Medical Device Daily Staff Report Abiomed (Danvers, Massachusetts) said InEK, the governmental authority for reimbursement in Germany, has granted the...

BioWorld releases new biodefense resource guid.
February 7, 2006... BioWorld releases new biodefense resource guide The editors of Medical Device Daily's sister publication, BioWorld Today, with data provided from the consulting firm BioAbility, have just completed a new resource guide for companies trying...

Court report.
February 7, 2006... Court report Hillenbrand pays $337.5 million to settle pricing practices suit A Medical Device Daily Staff Report Spartanburg Regional Healthcare System (Spartanburg, South Carolina) reported that the U.S. District Court for the...

Briefly Noted.
February 7, 2006... Briefly Noted India business delegation sets Indiana visit BioCrossroads (Indianapolis), the Indiana life sciences trade association, is co-sponsoring with the Indiana Economic Development Corp. a visit by a delegation of business...

Washington roundup.
February 7, 2006... Washington roundup Warning renewed for cochlear implant and risk of meningitis A Medical Device Daily Staff Report The FDA has issued a statement saying that a new Centers for Disease Control and Prevention (CDC; Atlanta)/FDA study...

Deals roundup.
February 7, 2006... Deals roundup Boston Scientific and Guidant file pre-merger notifications A Medical Device Daily Staff Report Boston Scientific (Natick, Massachusetts) and Guidant (Indianapolis) reported filing notifications with the U.S....

Agreements roundup.(Implant Sciences in agreement with Brachytherapy for prostate seed offering)(American Board of Internal Medicine's Comprehensive Care Practice Improvement Module)
February 7, 2006... Agreements roundup Implant Sciences, IBT pact covers prostate seed offering A Medical Device Daily Staff Report Implant Sciences (Wakefield, Massachusetts), a manufacturer of products for national security, medicine and industry,...

Financings roundup.
February 7, 2006... Financings roundup Accuro in $65M credit facility; RMT gets $9M from warrants A Medical Device Daily Staff Report GE Healthcare Financial Services led a $65 million senior credit facility for Accuro Healthcare Solutions (AHS;...

Lifeline moves facility from Florida to Bosto.
February 7, 2006... Lifeline moves facility from Florida to Boston Lifeline Biotechnologies (Reno, Nevada) said that the company would be relocating its facility in South Florida to Boston in order to cut costs and operate more efficiently. The new facility...

Product Briefs.(Perceptive Informatics releases Interactive Web Response System)(Signalife reports that Fidelity 100 Ambulatory EKG/ECG Monitor passes clinical testing)(Sutura receives FDA clearance for SuperStitch vascular suturing device)
February 7, 2006... Product Briefs * Perceptive Informatics (Boston), a subsidiary of Parexel International, reported the release of its Interactive Web Response System (IWRS) version 2.0. IWRS 2.0, a web interface for data capture, patient randomization and...

People in Places.
February 7, 2006... People in Places * Dr. Ralph Holsworth Jr. has been appointed to the managing director team of Rheologics (Exton, Pennsylvania), a subsidiary of Rheologics Technologies and developer of the Rheolog blood viscometer. Prior to joining...

New budget gives 3.8% hike to FDA, no increase for NIH.
February 8, 2006... New budget gives 3.8% hike to FDA, no increase for NIH By AARON LORENZO Medical Device Daily Washington Writer and DON LONG Medical Device Daily Managing Editor WASHINGTON -- The FDA is set to receive a modest budget...

F&S sees large growth for digital X-ray sector in Asia.
February 8, 2006... F&S sees large growth for digital X-ray sector in Asia By KAREN YOUNG Medical Device Daily Staff Writer Frost & Sullivan (F&S; Palo Alto, California) outlined research from its report on growth prospects for digital X-ray...

Report from Israel.
February 8, 2006... Report from Israel Given Imaging PillCam shows progress in Eastern Europe By RAE FISHMAN Medical Device Daily Contributing Writer ZICHRON YAAKOV, Israel -- Given Imaging's (Yokneam, Israel) PillCam SB Capsule Endoscope, used...

Emory University establishes Center for Device Innovation.
February 8, 2006... Emory University establishes Center for Device Innovation By DON LONG Medical Device Daily Managing Editor Using its five decades of clinical and research work in cardiovascular technology, Emory University (Atlanta) has rolled out...

Boston Sci reports progress on merger, regulatory issues.
February 8, 2006... Boston Sci reports progress on merger, regulatory issues By HOLLAND JOHNSON Medical Device Daily Associate Managing Editor Boston Scientific (Natick, Massachusetts) reported its 4Q05 and full-year earnings and during a conference...

Deals roundup.
February 8, 2006... Deals roundup Nanogen completes purchase of Spectral POC test business A Medical Device Daily Staff Report Nanogen (San Diego) reported that it has completed the purchase of the rapid cardiac immunoassay test business of Spectral...

Briefly Noted.
February 8, 2006... Briefly Noted FDA sponsors public workshop in Dallas The FDA's Office of Regulatory Affairs, Southwest Region, Dallas District Office, in collaboration with the FDA Medical Device Industry Coalition (FMDIC), is holding a public...

Financings roundup.(Theregen)(Guidant invested in Theregen)
February 8, 2006... Financings roundup Guidant invests in Theregen; Thoratec in new stock buyback A Medical Device Daily Staff Report Regenerative medicine firm Theregen (San Francisco) reported that it has received an undisclosed equity investment...

Court report.
February 8, 2006... Court report Cardica reveals IVIT action; SEC ends its probe of Chiron A Medical Device Daily Staff Report Cardica (Redwood City, California) reported the filing with the Securities and Exchange Commission (SEC) on Feb. 6, of a...

Endovascular intervention is focus of AIMS on BioDesign.
February 8, 2006... Endovascular intervention is focus of AIMS on BioDesign A Medical Device Daily Staff Report The American International Medical Summit on Bio-therapeutics and Medical Designs (AIMS on BioDesign), an inaugural event of the new Emory...

Agreements roundup.(Genesis Bioventures signed contract with Prion Laboratories)(PanGo Networks and Emergin Inc. signed a partnership)
February 8, 2006... Agreements roundup Genesis Bioventures in global pact with Prion Laboratories A Medical Device Daily Staff Report Genesis Bioventures (GBI; New York) said that the company has signed exclusive worldwide sales, marketing and...

People in Places.(Kay Cox resigned of the American Association for Homecare)(Cardiogenesis appointed Larry Czapla)(Joan Kennedy has been named president of Health Management Corp.)
February 8, 2006... People in Places * Kay Cox has stepped down as president and CEO of the American Association for Homecare (AAHomecare; Alexandria, Virginia). AAHomecare Chief Operating Officer Sue Mairena will continue to be responsible for the day-to-day...

Product Briefs.(Innovative Neurotronics got licence for WalkAide System first of functional electrical stimulation products)(Synbiotics received conditional approval for its Avian Influenza Virus Type A Antigen Test Kit)
February 8, 2006... Product Briefs * Hanger Orthopedic Group (Bethesda, Maryland) reported that its wholly owned subsidiary, Innovative Neurotronics (IN), received FDA 510(k) clearance to treat patients with the WalkAide System. The first of IN's line of...