Medical Device Week articles from March 2007

Medical Device Week archives from March 2007

Washington roundup.(Lester Crawford fined against conflict of interest case)(Baxter Healthcare Corp. gets license to market infusion pumps)(reports on health insurance)
March 1, 2007... Washington roundup Judge increases fine in former FDAer Crawford's plea bargain A Medical Device Daily Staff report Lester Crawford, former head of the FDA, was sentenced yesterday to three years of probation and a fine of $90,000...

GE study: Stark Relaxation seen as fueling EMR adoption.
March 1, 2007... HIMSS 2007 GE study: Stark Relaxation seen as fueling EMR adoption By KAREN YOUNG Medical Device Daily Staff Writer As the HIMSS (Chicago) conference was winding down in New Orleans this week, GE Healthcare (Waukesha,...

Report from Europe.(Cytori Therapeutics)(Medicsight gets license to market its products)
March 1, 2007... Report from Europe Cytori accelerates timetable of Celution system to market A Medical Device Daily Staff Report Cytori Therapeutics (San Diego) said it intends to commercialize its Celution System in Europe early next year for use...

Gateway Thoracolumbar System launched by Globus Medical.(Globus Medical )
March 1, 2007... Gateway Thoracolumbar System launched by Globus Medical By KAREN YOUNG Medical Device Daily Staff Writer Globus Medical (Audubon, Pennsylvania), which bills itself as the largest privately held spinal implant manufacturer in the...

Court report.(Escalon Medical Corp and IntraLase Corp. case)
March 1, 2007... Court report Escalon to gather in $9.6 million from settlement with IntraLase A Medical Device Daily Staff Report Escalon Medical (Wayne, Pennsylvania) reported that it has entered into an agreement with IntraLase (Irvine,...

Financings roundup.
March 1, 2007... Financings roundup Visiogen adds private $24M; Serica garners 'C' $12 million A Medical Device Daily Staff Report Visiogen (Irvine, California) reported that it has raised $24 million from new and current investors in support of...

Deals roundup.
March 1, 2007... Deals roundup Lab-on-a-chip firm Advanced Liquid Logic buys Nanolytics A Medical Device Daily Staff Report Advanced Liquid Logic (Research Triangle Park, North Carolina), a microfluidics "lab-on-a-chip" spinout from the Pratt...

Grants/contracts.
March 1, 2007... Grants/contracts Lokey donates $33M to Stanford for stem cell biology institute A Medical Device Daily Staff Report Lorry Lokey, the founder of Business Wire has said he will give a minimum of $33 million to help build a home for...

Agreements.
March 1, 2007... Agreements SFBR to study Hemopurifier from Aethlon for bioterror A Medical Device Daily Staff Report Aethlon Medical (San Diego), a developer of therapeutic devices for infectious disease, reported a research collaboration with The...

HIT workgroup head resigns, cites lack of 'substantial progress'.(American Health Information Community)(Paul Feldman)(Brief article)
March 1, 2007... HIT workgroup head resigns, cites lack of 'substantial progress' A Medical Device Daily Staff Report Paul Feldman, chair of the privacy and security workgroup of the American Health Information Community (AHIC), recently resigned from...

Medtronic rolls out succession plans for president, COO, CEO.
March 1, 2007... Medtronic rolls out succession plans for president, COO, CEO A Medical Device Daily Staff Report Medtronic (Minneapolis) yesterday reported roll-out of a succession plan for its top executive positions. William Hawkins III, company...

Product Briefs.
March 1, 2007... Product Briefs • Varian (Chicago) introduced its new 900-MS series Fourier Transform mass spectrometers. (FTMS) for applications including proteomics, metabolomics, petrochemical and environmental analyses. The available field...

People in Places.
March 1, 2007... People in Places • BioImagene (Cupertino, California) reported the appointment of four new senior executives: Vivek Pathak as CFO, Steven Barbee as VP of sales, Greg Loney as VP of instrumentation, and Himanshu Ubale as VP of...

Tempo inhaler may offer fast, consistent relief of migraines.
March 2, 2007... Tempo inhaler may offer fast, consistent relief of migraines By AMANDA PEDERSEN Medical Device Daily Staff Writer Anyone who has ever used a standard meter dose inhaler -- most commonly prescribed for asthma but more recently being...

Advanced BioHealing brings in $25.5M for Dermagraft launch.
March 2, 2007... Advanced BioHealing brings in $25.5M for Dermagraft launch By JIM SHRINE Medical Device Daily Staff Writer and Staff Reports A product that began development more than 15 years ago but never gained traction is back on the...

Report from Europe.
March 2, 2007... Report from Europe UK issues major proposals on regulating health professionals A Medical Device Daily Staff Report The UK government has published a White Paper outlining what were described as "landmark proposals" on how to...

Maquet links brain, diaphragm to improve mechanical ventilation.
March 2, 2007... Maquet links brain, diaphragm to improve mechanical ventilation By KAREN YOUNG Medical Device Daily Staff Writer With mechanical ventilation, sometimes a "battle" between the ventilator and patient ensues, with some patients...

Grants/contracts.
March 2, 2007... Grants/contracts LabCorp reports termination of its laboratory services by Aetna A Medical Device Daily Staff Report Laboratory Corporation of America Holdings (LabCorp; Burlington, North Carolina) yesterday reported that it will...

Court report.
March 2, 2007... Court report Quovadx settles for $9 million in financial restatement suit A Medical Device Daily Staff Report Quovadx (Greenwood Village, Colorado) reported that Senior District Judge Richard Matsch, in the federal court in the...

Agreements.(Greatbatch Technologies Inc enters into agreement with St. Jude Medical )
March 2, 2007... Agreements Greatbatch and St. Jude extend battery supplier pact to 2013 A Medical Device Daily Staff Report Greatbatch (Clarence, New York) and St. Jude Medical (St. Paul, Minnesota) reported entering into an amended supplier...

FDA issues update concerning Custom Ultrasonics products.
March 2, 2007... 'We disagree,' company says FDA issues update concerning Custom Ultrasonics products A Medical Device Daily Staff Report FDA has issued a "Dear Colleague" letter to practitioners as a follow-up to a Feb. 7 press statement that...

Product Briefs.
March 2, 2007... Product Briefs * AngioDynamics (Queensbury, New York) introduced its Smart Port CT at the 32nd annual scientific meeting of the Society of Interventional Radiology being held in Seattle. The new vascular access port is indicated for power...

People in Places.
March 2, 2007... People in Places * Thomas Blassey has been promoted to VP, U.S. sales, at Biosite (San Diego). Blassey will lead the company's sales organization, national accounts and sales and clinical training. Most recently, he was Biosite's...

Medtronic's Chronicle fails to win panel OK for approval.
March 5, 2007... Primary endpoint not met Medtronic's Chronicle fails to win panel OK for approval By MARK McCARTY Medical Device Daily Washington Editor GAITHERSBURG, Maryland -- FDA reviewers at the Center for Devices and Radiological Health...

St. Jude in neurostimulation trial for treatment of chronic angina.(Disease/Disorder overview)
March 5, 2007... St. Jude in neurostimulation trial for treatment of chronic angina By HOLLAND JOHNSON Medical Device Daily Managing Editor Neurostimulation technology is being used to treat a host of conditions, including epilepsy, Parkinson's...

International report.(Novadaq Technologies gets patent for its imaging system in Japan)(Cedara Software develops medical diagnostic software)
March 5, 2007... International report Novadaq gets Japanese patent for its SPY imaging system A Medical Device Daily Staff Report Novadaq Technologies (Toronto, Ontario) reported receiving a patent in Japan for its SPY Intra-operative Imaging...

Non-surgical treatments lead device therapies at meeting.
March 5, 2007... Society of Interventional Radiology Non-surgical treatments lead device therapies at meeting A Medical Device Daily Staff Report Research presented Friday at the Society of Interventional Radiology's (SIR; Fairfax, Virginia) 32nd...

Deals roundup.(Luminex corp. acquires Tm Bioscience)(Alliance HealthCard acquires Benefit Marketing Solutions )
March 5, 2007... Deals roundup Luminex closes on Tm Bio buy; AHC completes BMS merger A Medical Device Daily Staff Report Luminex (Austin, Texas) reported closing its acquisition of Tm Bioscience (Toronto). Each Tm common share will be...

Agreements roundup.(Illinois Hospital Association, Premier Purchasing Partners and Centegra Health System )(Brief article)
March 5, 2007... Agreements roundup Illinois, Premier report signing of Centegra into collaborative A Medical Device Daily Staff Report The Illinois Hospital Association (Naperville, Illinois) and Premier Purchasing Partners (Charlotte, North...

Contracts.
March 5, 2007... Contracts Netsmart to provide software to Illinois health department A Medical Device Daily Staff Report Netsmart Technologies (Great River, New York), a provider of enterprise-wide software and services for health and human...

Financings roundup.
March 5, 2007... Financings roundup Mylan Labs prices $1 billion in concurrent offerings A Medical Device Daily Staff Report Mylan Laboratories (Canonsburg, Pennsylvania) reported pricing of its concurrent public offerings for total proceeds of...

Briefly Noted.
March 5, 2007... Briefly Noted Study compares treatments in prostate cancer Men with prostate cancer have a slightly better long-term side effects profile with radiation seed implants than they do with surgery, according to a study released today in...

Product Briefs.
March 5, 2007... Product Briefs * Cytomyx (Cambridge, UK) reported that it has launched new biomarker tools from its earlier collaboration with OriGene Technologies (Rockville, Maryland). Cytomyx said it supplied hundreds of highly characterized RNA...

People in Places.
March 5, 2007... People in Places * Kevin Cordell was named new senior VP of global sales at FoxHollow Technologies (Redwood City, California), a developer of endovascular therapeutic devices for the treatment of peripheral artery disease (PAD). Cordell...

Panel doesn't relent in requiring RCTs for PFO/stroke indication.(patent foramen ovales, randomized, controlled clinical trials)(Food and Drug Administration approves trial of closures)
March 6, 2007... Panel doesn't relent in requiring RCTs for PFO/stroke indication By MARK McCARTY Medical Device Daily Washington Editor GAITHERSBURG, Maryland -- NMT Medical (Boston) and AGA Medical (Plymouth, Minnesota), two firms in the...

Boston Sci report reveals up-tick in Guidant ICD-related lawsuits.
March 6, 2007... Boston Sci report reveals up-tick in Guidant ICD-related lawsuits A Medical Device Daily Staff Report Despite the purported benefits of Boston Scientific's (Natick, Massachusetts) $27.2 billion acquisition of Guidant (Indianapolis) last...

Expo reaches a critical mass for European device makers.
March 6, 2007... MEDTEC 2007 Expo reaches a critical mass for European device makers By JOHN BROSKY Medical Device Daily Contributing Writer STUTTGART -- The German medical device industry was in its glory on the second day of the MEDTEC 2007...

Gen-Probe's Procleix Tigris cleared for WNV blood screening.
March 6, 2007... Gen-Probe's Procleix Tigris cleared for WNV blood screening By KAREN YOUNG Medical Device Daily Staff Writer The FDA took the fairly infrequent step this week of issuing a statement concerning a product clearance, this one...

Financings roundup.
March 6, 2007... Financings roundup Disc Dynamics, PneumrX each raise $27 million in new funds A Medical Device Daily Staff Report Disc Dynamics (Eden Prairie, Minnesota) reported that it has raised $27 million in new financing. Disc Dynamics...

Deals roundup.
March 6, 2007... Deals roundup Wright Medical buys Darco's foot surgery line for $17 million By AMANDA PEDERSEN Medical Device Daily Staff Writer Wanting to expand its portfolio of reconstructive foot and ankle products, Wright Medical Group...

Agreements roundup.
March 6, 2007... Agreements roundup Siemens Molecular Imaging in pact with Wyeth Pharmaceuticals A Medical Device Daily Staff Report The Molecular Imaging division of Siemens Medical Solutions (Hoffman Estates, Illinois) a provider of molecular...

Grants/contracts.
March 6, 2007... Grants/contracts Eisenhower Medical inks $14.8M contract with McKesson for IT A Medical Device Daily Staff Report Eisenhower Medical Center (Ranchero Mirage, California) reported that it has selected McKesson (San Francisco) for...

Court report.
March 6, 2007... Court report Home Diagnostics reports win in suit over TrueTrack patent A Medical Device Daily Staff Report Home Diagnostics (Fort Lauderdale, Florida), a manufacturer of diabetes testing supplies, reported that on March 2, the...

Briefly Noted.
March 6, 2007... Briefly Noted B&L reports delay filing annual report to SEC Bausch & Lomb (B&L; Rochester, New York) has filed a Form 12b-25 with the Securities and Exchange Commission, indicating that it must delay filing its annual report on Form...

Upcoming March med-tech conferences.
March 6, 2007... Upcoming March med-tech conferences Advanced Medical Technology Association (AdvaMed) Annual Meeting, March 7-9, Chandler, AZ www.advamed.org Frost & Sullivan Annual Medical Devices '07 March 11-14, Grand Hyatt, San...

Product Briefs.
March 6, 2007... Product Briefs * InSightec (Haifa, Israel) reported FDA approval of software that speeds the treatment time of the company's ExAblate 2000 MR-guided Focused Ultrasound (MRgFUS) system, while ensuring the system's safety and efficacy....

Medtronic files final PMA module for Talent stent graft.
March 6, 2007... Medtronic files final PMA module for Talent stent graft A Medical Device Daily Staff Report Medtronic (Minneapolis) yesterday reported that it has submitted the final module of its pre-market approval (PMA) application to the FDA for...

People in Places.
March 6, 2007... People in Places * Jack Darby has been named VP worldwide sales and marketing, for AGA Medical (Plymouth, Minnesota). Darby previously was VP of global stent marketing at Cordis, his responsibilities including global marketing and...

House committee to examine off-label DES, drug marketing.
March 7, 2007... House committee to examine off-label DES, drug marketing By HOLLAND JOHNSON Medical Device Daily Managing Editor A congressional committee has launched a probe concerning the "off-label" use of drug-eluting stents (DES) and drugs,...

Meeting showcases newest of minimally invasive strategies.
March 7, 2007... Society of Interventional Radiology Meeting showcases newest of minimally invasive strategies By LARRY HAIMOVITCH Medical Device Daily Contributing Writer SEATTLE -- Over the past decade, the medical community has increasingly...

Industry faces big challenges in move from micro to nano.
March 7, 2007... MEDTEC 2007 Industry faces big challenges in move from micro to nano By JOHN BROSKY Medical Device Daily Contributing Writer STUTTGART, Germany -- "Ideas about nanotechnologies are far more numerous than nano-products," noted...

Washington roundup.
March 7, 2007... Washington roundup FDA issues early DST warning, potential impact on devices By MARK McCARTY Medical Device Daily Washington Editor WASHINGTON -- FDA is warning those who use devices controlled by a clock that the onset of...

Financings roundup.
March 7, 2007... Financings roundup DexCom prices $40M convertible senior notes in private offering A Medical Device Daily Staff Report DexCom (San Diego) reported the pricing of $40 million of convertible senior notes, due 2027, in a private...

B&L issues voluntary recall of contaminated lens solution.
March 7, 2007... B&L issues voluntary recall of contaminated lens solution A Medical Device Daily Staff Report Bausch & Lomb (B&L; Rochester, New York) can't seem to see the end to its lens solution problems. Yesterday the company reported...

Grants/contracts.
March 7, 2007... Grants/contracts Spacenet in hybrid networking pact with OSU Telemedicine A Medical Device Daily Staff Report Spacenet (McLean, Virginia), a provider of satellite and hybrid terrestrial networking solutions, said it was selected by...

Researchers: angioplasty/stent treatment effective for PAD.
March 7, 2007... SIR notebook Researchers: angioplasty/stent treatment effective for PAD A Medical Device Daily Staff Report Research presented this week at the 32nd annual scientific meeting of the Society of Interventional Radiology (SIR;...

Agreements.
March 7, 2007... Agreements HealthTronics in new pact with Lisa Laser for RevoLix A Medical Device Daily Staff Report HealthTronics (Austin, Texas) reported the completion of a long-term supply and development agreement with Lisa Laser OHG...

Product Briefs.
March 7, 2007... Product Briefs * Advanced Magnetics (Cambridge, Massachusetts) reported that the independent data monitoring committee (DMC) providing oversight of the ferumoxytol Phase III intravenous iron replacement therapy program met for the final...

People in Places.
March 7, 2007... People in Places * Ryan Rauch has been retained by Applied NeuroSolutions (Vernon Hills, Illinois) as an investment relations consultant. Rauch previously was an analyst at Jefferies & Company. Applied NeuroSolutions makes products...

Financings roundup.
March 8, 2007... Financings roundup CircuLite 'B' $20 million boosts 'AA'-sized Synergy heart pump By DON LONG Medical Device Daily Executive Editor A company positioning itself to provide help for heart failure patients before they need a...

Aethlon Medical submits IDE for safety study of Hemopurifier.
March 8, 2007... Aethlon Medical submits IDE for safety study of Hemopurifier By KAREN YOUNG Medical Device Daily Staff Writer In the latest chapter in its ongoing drive toward commercialization of its Hemopurifier, Aethlon Medical (San Diego) said...

Report from Europe.
March 8, 2007... Report from Europe CE mark, 1st implants reported for Sorin's Reply pacemakers A Medical Device Daily Staff Report The Sorin Group (Milan, Italy) reported CE-marking and first implants of its next-generation Reply pacemakers,...

FDA to review Roche Diagnostics automated blood screening test.
March 8, 2007... FDA to review Roche Diagnostics automated blood screening test By AMANDA PEDERSEN Medical Device Daily Staff Writer Recognizing the importance of enabling blood banks to quickly screen for a broad range of human immunodeficiency...

Briefly Noted.
March 8, 2007... Briefly Noted St. Jude completes IHE testing St. Jude Medical (St. Paul, Minnesota) said it completed the testing process established by the IHE (Integrating the Healthcare Enterprise), an initiative promoting the adoption of...

Guilford recalling two AEDs; BSD gets FDA warning letter.
March 8, 2007... Guilford recalling two AEDs; BSD gets FDA warning letter A Medical Device Daily Staff Report Defibtech (Guilford, Connecticut) reported that it has launched a recall of all of its Lifeline AED and ReviveR AEDTM semi-automatic external...

Deals roundup.
March 8, 2007... Deals roundup Candela acquiring Inolase for $16.5M, creates 2 new units A Medical Device Daily Staff Report Candela (Wayland, Massachusetts) reported that it will acquire all share capital of Inolase (Netanya, Israel), in a cash...

Court report.
March 8, 2007... Court report Canadian court upholds Ventas deal to buy Sunrise for $1.8B A Medical Device Daily Staff Report Ventas (Louisville, Kentucky), a real estate investment trust, reported that the Ontario Superior Court of Justice has...

Grants/contracts.
March 8, 2007... Grants/contracts APS expands management and informatics services to Georgia A Medical Device Daily Staff Report APS Healthcare (Silver Spring, Maryland), a specialty healthcare company, reported being selected by the Georgia...

FlowMedica's Benephit infusion device highlighted for TRT use.
March 8, 2007... Society of Interventional Radiology notebook FlowMedica's Benephit infusion device highlighted for TRT use A Medical Device Daily Staff Report Data from a multi-center registry of targeted renal therapy (TRT) in patients at high...

Product Briefs.
March 8, 2007... Product Briefs * BioSphere Medical (Rockland, Massachusetts) reported that a study published in the March 2007 issue of Journal of Vascular and Interventional Radiology concluded that over the long term, uterine fibroid embolization using...

People in Places.
March 8, 2007... People in Places * Victor Diaz has been named senior VP of global manufacturing and supply chain management for Angiotech Pharmaceuticals (Vancouver, British Columbia). Prior to joining Angiotech, Diaz was VP of global operations at...

FDA pledges spring release of draft guidance for DES trials.(drug eluting stents)
March 9, 2007... Agency to hold May hearing FDA pledges spring release of draft guidance for DES trials By MARK McCARTY Medical Device Daily Washington Editor WASHINGTON -- FDA's two-day hearing in December on drug-eluting stents (DES)...

Task force advocates consumer access to new neurotechnologies.
March 9, 2007... Task force advocates consumer access to new neurotechnologies By AMANDA PEDERSEN Medical Device Daily Staff Writer Neurotech companies are on the verge of bringing to market a whole new world of neuromodulation devices to treat...

Report from Europe.
March 9, 2007... Report from Europe InterGenetics' OncoVue test is released in UK and Ireland A Medical Device Daily Staff Report InterGenetics (Oklahoma City), a predictive medicine company focused on molecular diagnostics and targeted therapy for...

Respironics system FDA-cleared for treatment of "complex" OSA.
March 9, 2007... Respironics system FDA-cleared for treatment of 'complex' OSA By HOLLAND JOHNSON Medical Device Daily Managing Editor Patients who suffer from a complex form of obstructive sleep apnea (OSA) may now be able breathe easier thanks...

Deals roundup.
March 9, 2007... Deals roundup Clarient spins off ACIS, Trestle to Carl Zeiss MicroImaging A Medical Device Daily Staff Report Clarient (Aliso Viejo, California) yesterday reported that it will sell its Automated Cellular Imaging System (ACIS) and...

Clarification.(Correction notice)
March 9, 2007... Clarification The article headlined "Panel doesn't relent in requiring RCTs for PFO/stroke indication" (Medical Device Daily, March 6, 2007) mistakenly identified AGA Medical (Plymouth, Minnesota) as one of the companies that had...

Court report.
March 9, 2007... Court report PolyMedica disagrees with ruling vs. Liberty Medical, sets reserve A Medical Device Daily Staff Report PolyMedica (Wakefield, Massachusetts) reported that the Federal District Court in Fort Pierce, Florida, has...

Agreements.
March 9, 2007... Agreements NxStage, Renal Advantage in pact for dialysis services A Medical Device Daily Staff Report NxStage Medical (Lawrence, Massachusetts), maker of the NxStage System One portable kidney dialysis machine, and Renal Advantage...

AngioJet thrombectomy system able to bust clots, study says.
March 9, 2007... Society of Interventional Radiology notebook AngioJet thrombectomy system able to bust clots, study says A Medical Device Daily Staff Report With the AngioJet Rheolytic Thrombectomy System from Possis Medical (Minneapolis), an...

Financings roundup.
March 9, 2007... Financings roundup AMO's Mazzo alters trading plan; CorNova selling Implant shares A Medical Device Daily Staff Report Advanced Medical Optics (AMO; Santa Ana, California), a developer of ophthalmic surgical devices and eye care...

Briefly Noted.
March 9, 2007... Briefly Noted AAA repair market predicted to soar Millennium Research Group (MRG; Waltham, Massachusetts) reported that its analysis of the peripheral vascular device market finds that the second largest segment of the market,...

Product Briefs.
March 9, 2007... Product Briefs * eyeonics (Aliso Viejo, California) reported that the crystalens Five-O is now available in an expanded range of 10 to 30 diopters. In addition, in the range of the most commonly used diopters, 16 to 27, the Five-O is...

People in Places.
March 9, 2007... People in Places * TeamStaff (Atlanta) reports two changes at its subsidiaries. Tim Nieman has stepped down as president of RS Staffing Services (a government contract staffing subsidiary), and Terry Merlin was hired as director of sales...