Medical Device Week articles from February 2005

Medical Device Week archives from February 2005

Molecular tests likely to extend entire spectrum of diagnostics.
February 1, 2005... Piper Jaffray Health Care Conference Molecular tests likely to extend entire spectrum of diagnostics By DON LONG Medical Device Daily Managing Editor NEW YORK - Molecular testing, otherwise known as genetic testing, is the hot...

Biopure, others remain on long road with oxygen therapeutics.
February 1, 2005... Chasing artificial blood Biopure, others remain on long road with oxygen therapeutics By BRADY HUGGETT Medical Device Daily Staff Writer Picture a company with a great idea. Then picture FDA roadblocks, lawsuits flying, a...

Report from Europe.
February 1, 2005... Report from Europe [pounds sterling]95 million allocated to help spur 'Choose and Book' in UK A Medical Device Daily Staff Report Some [pounds sterling]95 million in funding will go to UK Primary Care Trusts (PCTs) that offer a...

Washington roundup.
February 1, 2005... Washington roundup CMS hits the ground running; PET gets expanded coverage By CHRISTOPHER DELPORTE Medical Device Daily Washington Editor WASHINGTON - The Centers for Medicare & Medicaid Services (CMS; Baltimore) has had a...

Financings roundup.
February 1, 2005... Financings roundup Healthcare VC funding soars; Boston Sci invests in TyRx A Medical Device Daily Staff Report Reversing three consecutive years of declines, health industry companies received a record share of venture capital...

Deals roundup.
February 1, 2005... Deals roundup Merge merges with AccuImage; IHH restructures Tenet accord A Medical Device Daily Staff Report Merge Technologies (Milwaukee), doing business as Merge eFilm, reported the closing of its acquisition of AccuImage...

AACC launches new division whose focus is on proteomics.
February 1, 2005... AACC launches new division whose focus is on proteomics A Medical Device Daily Staff Report The American Association for Clinical Chemistry (AACC; Washington) has launched a Proteomics Division in light of the increasing importance of...

Briefly Noted.
February 1, 2005... Briefly Noted Aspect Medical amends Boston Sci agreement Aspect Medical Systems (Newton, Massachusetts) reported that it has amended its product development agreement with Boston Scientific (Natick, Massachusetts) to provide a two-year...

Product Brief.
February 1, 2005... Product Brief * Quinton Cardiology Systems (Bothell, Washington) reported that it has added a new electrocardiograph (ECG), the Eclipse Premier, to its product line. Use of Eclipse Premier can lead to quicker diagnoses, the company said,...

People in Places.
February 1, 2005... People in Places * William Hamburg has been appointed interim CEO of Cogent Healthcare (Irvine, California), a hospitalist company. Hamburg, who will remain in the role of CEO until the search for a long-term CEO is completed, was...

Boston Sci completes initial launch of Taxus Liberte stent.(Brief Article)
February 1, 2005... Boston Sci completes initial launch of Taxus Liberte stent A Medical Device Daily Staff Report Boston Scientific (Natick, Massachusetts) reported that it has completed the initial launch of its Taxus Liberte paclitaxel-eluting coronary...

WorldHeart deal for MedQuest is a VAD sector consolidation.(ventricular assist device)
February 2, 2005... WorldHeart deal for MedQuest is a VAD sector consolidation By DON LONG Medical Device Daily Managing Editor Heart support devices that beat and those that whir will come together in complementary fashion with WorldHeart's (Oakland,...

Clearance for AxiaLIF brings TranS1 to financial crossroads.
February 2, 2005... Clearance for AxiaLIF brings TranS1 to financial crossroads By HOLLAND JOHNSON Medical Device Daily Associate Managing Editor TranS1 (Wilmington, North Carolina), a privately held firm focused on developing minimally invasive...

International report.
February 2, 2005... International report Endo-microscope components set firm on path to success A Medical Device Daily Staff Report Japanese imaging giant Pentax has placed a first-year order worth more than A$5 million with Optiscan Imaging...

Animas rolls out carb-counting and tune-playing insulin pump.
February 2, 2005... 1st of two stories Animas rolls out carb-counting and tune-playing insulin pump By KAREN YOUNG Medical Device Daily Staff Writer Smaller, lighter, niftier and easier to use - while still containing both more features and more...

FDA gives alert on syringes; urine-processing kits recalled.
February 2, 2005... FDA gives alert on syringes; urine-processing kits recalled A Medical Device Daily Staff Report The FDA has issued a nationwide alert warning concerning the use of all lots of preloaded syringes containing either heparin or sodium...

Cord Blood gets OK to trade on OTC Bulletin Board.(Brief Article)
February 2, 2005... Cord Blood gets OK to trade on OTC Bulletin Board Cord Blood America (Los Angeles) has commenced trading on the Nasdaq OTC Bulletin Board under the symbol CBAI. Cord Blood America is the parent company of Cord Partners, which...

Deals roundup.
February 2, 2005... Deals roundup Meridian buys O.E.M. Concepts; Banyan forms Diagnostics USA A Medical Device Daily Staff Report Meridian Bioscience (Cincinnati) reported completing the acquisition of the outstanding capital stock of O.E.M. Concepts...

Financings roundup.
February 2, 2005... Financings roundup MTI gets milestone payment; Insight extends exchange offer A Medical Device Daily Staff Report Micro Therapeutics (MTI; Irvine, California) reported receiving a $3.7 million payment resulting from the acquisition...

Biomet launches Cobalt bone cement in U.S.(Brief Article)
February 2, 2005... Biomet launches Cobalt bone cement in U.S. Biomet (Warsaw, Indiana) said it would broaden the range of its internally developed and manufactured bone cement product offering. Cobalt, which was specifically developed for use in minimally...

Grants/contracts.
February 2, 2005... Grants/contracts Spire receives SBIR grant to develop dialysis catheters A Medical Device Daily Staff Report Spire (Bedford, Massachusetts) reported the receipt of a two-year Small Business Innovation Research Phase II grant of...

JCAHO changes access to Periodic Performance Review.(Joint Commission on Accreditation of Healthcare Organizations)(Brief Article)
February 2, 2005... JCAHO changes access to Periodic Performance Review A Medical Device Daily Staff Report The Joint Commission on Accreditation of Healthcare Organizations (JCAHO; Oakbrook Terrace, Illinois) has implemented a change that will allow...

Product Briefs.
February 2, 2005... Product Briefs * Aastrom Biosciences (Ann Arbor, Michigan) reported that its U.S. clinical trial of its Tissue Repair Cell (TRC) product - a mix of bone marrow stem and progenitor cells - intended for the treatment of long-bone, severe...

People in Places.
February 2, 2005... People in Places * Joel White has been promoted to vice president of process integration for Global Dosimetry Solutions (GDS; Irvine, California), a provider of personal radiation monitoring solutions. He joined GDS in 1996, and has served...

Court report.
February 2, 2005... Court report Angiotech, Boston Scientific in suit vs. Conor Medsystems A Medical Device Daily Staff Report Angiotech Pharmaceuticals (Vancouver) on Tuesday reported that it and Boston Scientific (Natick, Massachusetts), its...

Women miss out on receiving life-saving cardiac procedures.
February 3, 2005... Women miss out on receiving life-saving cardiac procedures By CHRISTOPHER DELPORTE Medical Device Daily Washington Editor WASHINGTON - Women suffering from cardiovascular disease outnumber men, according to the American Heart...

OmniPod Insulin System offers new pump to manage diabetes.
February 3, 2005... 2nd of two stories OmniPod Insulin System offers new pump to manage diabetes By KAREN YOUNG Medical Device Daily Staff Writer Insulet (Bedford, Massachusetts) has accomplished precisely what it set out to do for diabetes...

Report from Europe.
February 3, 2005... Report from Europe UK pushes review of medical practice and patient safety A Medical Device Daily Staff Report The UK government is undertaking a review into patient safety in a move intended to help protect patients from poor...

PolyMedica, Owens & Minor acquire diabetes supply firms.
February 3, 2005... PolyMedica, Owens & Minor acquire diabetes supply firms A Medical Device Daily Staff Report Given the growth of the number of persons diagnosed with diabetes, supplies to patients in that market are a sure bet. And two companies have...

Court report.
February 3, 2005... Court report 2nd HealthSouth exec testifies Scrushy said, 'adjust earnings' A Medical Device Daily Staff Report For the second time in a week, a former HealthSouth (Birmingham, Alabama) CFO has testified that he was given direct...

Briefly Noted.
February 3, 2005... Briefly Noted Amex accepts Milestone compliance plan Milestone Scientific (Livingstone, New Jersey) said that the American Stock Exchange (Amex) had accepted the company's plan for regaining compliance with the exchange's stockholder...

Financings roundup.
February 3, 2005... Financings roundup VisiJet closes on $4.9M round; InSight exchange offer expires A Medical Device Daily Staff Report VisiJet (Irvine, California), a developer of technologies for the ophthalmic surgical market, has closed on a...

Deals roundup.
February 3, 2005... Deals roundup MicroMed Tech, maker of the DeBakey VAD, in merger plan A Medical Device Daily Staff Report Salmon Express (Vernon, British Columbia) reported signing an agreement to merge with heart pump developer MicroMed...

Grants/contracts.
February 3, 2005... Grants/contracts GNS is awarded two NIH grants; MAGNET, Zassi in agreeement A Medical Device Daily Staff Report Gene Network Sciences (GNS; Ithaca, New York) reported that it has been awarded two Phase One Small Business Innovation...

Product Briefs.
February 3, 2005... Product Briefs * Infectech (Sharon, Pennsylvania), which is developing technologies for the production of bacteria and disease testing kits, reported that it has received notification from the FDA of registration of the company and its...

People in Places.
February 3, 2005... People in Places * Laserscope (San Jose, California) reported several management appointments. Peter Hadrovic has been named vice president, legal affairs and general counsel, joining the company from the Heller Ehrman/Venture Law Group....

Cyberonics' therapy deemed approvable for depression use.
February 4, 2005... Cyberonics' therapy deemed approvable for depression use By HOLLAND JOHNSON Medical Device Daily Associate Managing Editor After an odyssey of six years, it appears that Cyberonics (Houston) will finally get U.S. approval for use...

Programs on track with MMA schedule, says CMS's Tunis.(Medicare Modernization Act; Centers for Medicare & Medicaid Services )
February 4, 2005... Programs on track with MMA schedule, says CMS's Tunis By CHRISTOPHER DELPORTE Medical Device Daily Washington Editor WASHINGTON - Sean Tunis, MD, chief medical officer at the Centers for Medicare & Medicaid Services (CMS;...

Report from Europe.
February 4, 2005... Report from Europe Agendia develops test aimed at tumors of unknown origin A Medical Device Daily Staff Report Agendia (Amsterdam, the Netherlands) and Arcturus (Mountain View, California) have signed a license agreement under...

Cerus, Baxter re-do Intercept pact, settle dispute over loan.(Baxter International)
February 4, 2005... Cerus, Baxter re-do Intercept pact, settle dispute over loan By DON LONG Medical Device Daily Managing Editor Subsidiaries of Baxter International (Deerfield, Illinois) and Cerus (Concord, California) yesterday said they have...

MDMA: New report challenges GPOs' 'unsubstantiated claims'.(Medical Device Manufacturers Association; group purchasing organization)
February 4, 2005... MDMA: New report challenges GPOs' 'unsubstantiated claims' By DON LONG Medical Device Daily Managing Editor The Medical Device Manufacturers Association (MDMA; Washington) is continuing its criticism of the group purchasing...

Deals roundup.
February 4, 2005... Deals roundup Encore adds OTI for $14.5M; Biophan in Amris integration A Medical Device Daily Staff Report Encore Medical (Austin, Texas) reported entering into an agreement to acquire substantially all of the assets of...

Grants/contracts.
February 4, 2005... Grants/contracts Paladin enters $1.8M pact with Army for ODIN program A Medical Device Daily Staff Report Paladin Data Systems (Poulsbo, Washington), a privately owned software engineering solutions firm, said it has been awarded a...

Financings roundup.
February 4, 2005... Financings roundup Xenomics adds $2.9M for R&D on non-invasive gene markers A Medical Device Daily Staff Report Xenomics (New York), a developer of diagnostic technologies for medical and life sciences applications, reported...

Court report.
February 4, 2005... Court report One ruling reversed prior to Medtronic-Guidant patent trial A Medical Device Daily Staff Report Medtronic (Minneapolis) reported this week that the U.S. District Court in Delaware has reversed its previous ruling,...

People in Places.
February 4, 2005... People in Places * Joel White has been promoted to vice president of process integration for Global Dosimetry Solutions (GDS; Irvine, California), a provider of personal radiation monitoring solutions. He joined GDS in 1996, and has served...

Product Briefs.
February 4, 2005... Product Briefs * Avanca Medical Devices (Albuquerque, New Mexico) reported FDA 510(k) clearance of its interventional specialty procedure syringes, the Procedur-10 and Procedur-SF. The Procedur family of syringes allows healthcare...

CMS broadens need, codes for power wheelchairs, scooters.(Centers for Medicare & Medicaid Services)
February 7, 2005... CMS broadens need, codes for power wheelchairs, scooters By DON LONG Medical Device Daily Managing Editor Navigating between the Scylla of an industry clamoring for broader reimbursement of power wheelchairs and the Charybdis...

Charite device is focus of disc replacement webcast.
February 7, 2005... Charite device is focus of disc replacement webcast By CYNTHIA DRAKE, RN Medical Device Daily Contributing Writer Late last month, a surgical team at The Spine Institute at Beth Israel Medical Center (New York) performed a live...

International report.
February 7, 2005... International report DOBI continues international push with 2 new distributors A Medical Device Daily Staff Report DOBI Medical International (Mahwah, New Jersey) reported another step in its continued expansion into international...

Financings roundup.
February 7, 2005... Financings roundup Northfield Laboratories eyes $67.5 million in shelf offering A Medical Device Daily Staff Report Oxygen therapeutics developer Northfield Laboratories (Evanston, Illinois) has priced its offering of 4.5 million...

NIEHS adds X-rays, grilled meats to list of cancer agents.
February 7, 2005... NIEHS adds X-rays, grilled meats to list of cancer agents A Medical Device Daily Staff Report X-rays, viruses and compounds found in grilled meats have joined the official list of known or suspected cancer-causing agents. The list,...

ClaimRemedi agreement amended.(Brief Article)
February 7, 2005... ClaimRemedi agreement amended Cash Technologies (Los Angeles) reported that its Heuristic Technologies subsidiary has signed an amendment to its agreement with ClaimRemedi (Santa Rosa, California), a California developer of...

Deals roundup.
February 7, 2005... Deals roundup Parentech in reverse merger; Axtive to buy Datatek Group A Medical Device Daily Staff Report Parentech (Solana Beach, California), a newborn and infant technology company, reported that it has completed a reverse...

Varian Medical forms new unit with a focus on neurosurgery.
February 7, 2005... Varian Medical forms new unit with a focus on neurosurgery A Medical Device Daily Staff Report Varian Medical Systems (Palo Alto, California), known for its leadership position in radiation oncology products, has formed a new unit...

Court report.
February 7, 2005... Court report Another former HealthSouth executive charged with fraud A Medical Device Daily Staff Report HealthSouth's (Birmingham, Alabama) former president and chief operating officer, James Bennett, last week became the latest...

Briefly Noted.
February 7, 2005... Briefly Noted Americans believe U.S. not best healthcare system According to a new survey, the majority (60%) of Americans believe the U.S. does not have the best healthcare system in the world, and 64% say most Americans do not get...

Product Briefs.
February 7, 2005... Product Briefs * Candela (Wayland, Massachusetts) said it would introduce next-generation I2PL technology for skin rejuvenation of vascular and pigmented abnormalities. Through a partnership with Danish Dermatologic Development (DDD),...

People in Places.
February 7, 2005... People in Places * Illumina (San Diego) named William Rastetter, PhD, non-executive chairman of the board and promoted John Stuelpnagel to the newly created position of chief operating officer. Rastetter continues full-time as the...

Ripples from new ethics rules likely to impact NIH staffing.
February 8, 2005... Ripples from new ethics rules likely to impact NIH staffing By AARON LORENZO Medical Device Daily Washington Writer WASHINGTON - New ethics guidelines rolled out by the leadership of the National Institutes of Health (NIH;...

Some progress reported in treating more stroke victims.
February 8, 2005... International Stroke Conference Some progress reported in treating more stroke victims By LARRY HAIMOVITCH Medical Device Daily Contributing Writer NEW ORLEANS - While a festive atmosphere was building outside as annual Mardi...

Report from Europe.
February 8, 2005... Report from Europe New UK rules designed to deal with animal extremists By NUALA MORAN Medical Device Daily Correspondent and Staff Reports Animal rights extremists face jail terms of up to five years if they cause...

NovaBone found equivalent to BMP-2 in use in a composite.
February 8, 2005... NovaBone found equivalent to BMP-2 in use in a composite By HOLLAND JOHNSON Medical Device Daily Associate Managing Editor NovaBone Products (Jacksonville, Florida) reported that the results of an independent clinical study of 20...

DexCom IPO filing for $70M follows 'D' $22.5M placement.
February 8, 2005... DexCom IPO filing for $70M follows 'D' $22.5M placement A Medical Device Daily Staff Report Potentially bringing large new public financing to a recently successful private placement, DexCom (San Diego) last week filed with the...

EDAP retains Halliburton Investor Relations.(Brief Article)
February 8, 2005... EDAP retains Halliburton Investor Relations EDAP TMS (Vaulx-en-Velin, France) has retained Halliburton Investor Relations (Dallas) to assist the company in its efforts to communicate with the investment community. EDAP TMS manufactures...

Financings roundup.
February 8, 2005... Financings roundup Over-allotment will add $10M to Northfield's recent offering A Medical Device Daily Staff Report Northfield Laboratories (Evanston, Illinois) reported that the underwriters of its previously reported offering of...

Court report.
February 8, 2005... Court report OrthoClear launches system, responds to lawsuit by Align A Medical Device Daily Staff Report OrthoClear (San Francisco) last week reported the upcoming release of its OrthoClear System, a series of clear plastic...

Deals roundup.
February 8, 2005... Deals roundup Jabil to acquire Varian VEM business for $195M in cash A Medical Device Daily Staff Report Jabil Circuit (St. Petersburg, Florida) reported its intention to acquire the business and assets of Varian Electronics...

FDA okays 1st generic version of Fentanyl transdermal patch.
February 8, 2005... FDA okays 1st generic version of Fentanyl transdermal patch A Medical Device Daily Staff Report The FDA has cleared the way for generic versions of transdermal patches to treat chronic pain with its approval late last month of Mylan...

U.S. distribution rights go to Zimmer.(Brief Article)
February 8, 2005... U.S. distribution rights go to Zimmer Zimmer Holdings (Warsaw, Indiana), a worldwide leader in the orthopedics industry, said it has acquired U.S. distribution rights for the Palacos line of bone cement products manufactured by Heraeus...

Product Briefs.
February 8, 2005... Product Briefs * Raytel Cardiac Services (Windsor, Connecticut), a provider of remote pacemaker monitoring and cardiac diagnostic testing, said a study published in the January Annals of Internal Medicine found that heart patients on...

New catheter contaminations lead to reissued FDA alert.
February 8, 2005... New catheter contaminations lead to reissued FDA alert A Medical Device Daily Staff Report The FDA has reissued a nationwide alert warning against the use of all lots of preloaded syringes containing either heparin or sodium chloride...

Nexon joins AdvaMed as new Sr. executive vice president.(Advanced Medical Technology Association appoints David Nexon)(Brief Article)
February 8, 2005... Nexon joins AdvaMed as new Sr. executive vice president A Medical Device Daily Staff Report David Nexon, a Capitol Hill health policy expert, will join the Advanced Medical Technology Association (AdvaMed; Washington) as senior...

People in Places.
February 8, 2005... People in Places * Robert Weiss, executive vice president and CFO of The Cooper Companies (Lake Forest, California), has been named executive vice president and chief operating officer. Steven Neil, formerly CFO of Ocular Sciences, which...

Bush's proposed '06 budget pencils in added HHS funds.(Department of Health and Human Services budget)
February 9, 2005... Bush's proposed '06 budget pencils in added HHS funds By CHRISTOPHER DELPORTE Medical Device Daily Washington Editor WASHINGTON - Despite proposed cuts for 12 out of 23 major government agencies in the proposed federal budget for...

Invitrogen adding Dynal and 'bead' technology for $380M.(Dynal Biotech purchase)
February 9, 2005... Invitrogen adding Dynal and 'bead' technology for $380M By DON LONG Medical Device Daily Managing Editor In a move intended to broaden both its internal development efforts and its services to OEM diagnostics manufacturers,...

Report from Europe.
February 9, 2005... Report from Europe Medical engineering/physics institute is launched in Wales A Medical Device Daily Staff Report Cardiff University's (Cardiff, Wales) School of Engineering has launched the Institute of Medical Engineering and...

Genzyme adds MACI product with $10M Verigen purchase.(matrix-induced autologous chondrocyte implantation)(Genzyme Biosurgery buys Verigen of Germany)
February 9, 2005... Genzyme adds MACI product with $10M Verigen purchase By HOLLAND JOHNSON Medical Device Daily Associate Managing Editor Genzyme's (Cambridge, Massachusetts) Genzyme Biosurgery unit reported acquiring Verigen (Leverkusen, Germany), a...

HHS and CMS issue proposed regulations for e-prescribing.
February 9, 2005... HHS and CMS issue proposed regulations for e-prescribing By CHRISTOPHER DELPORTE Medical Device Daily Washington Editor WASHINGTON - As part of the Department of Health and Human Services' (HHS) push toward a national system of...

Financings roundup.
February 9, 2005... Financings roundup ACS invests $24M in Beacon; Payformance round nets $6M A Medical Device Daily Staff Report American Capital Strategies (ACS; Bethesda, Maryland) reported that it has invested $24 million in Beacon Hospice...

FDA gives consumer warning concerning Globus home tests.(Globus Media home medical test kits )(Brief Article)
February 9, 2005... FDA gives consumer warning concerning Globus home tests A Medical Device Daily Staff Report The FDA has issued a warning for consumers not to use unapproved home-use diagnostic test kits that have been marketed nationwide over the...

Deals roundup.
February 9, 2005... Deals roundup Lifestream transfers 'smart' health records IP to LifeNexus A Medical Device Daily Staff Report Lifestream Technologies (Post Falls, Idaho), a supplier of cholesterol monitors, reported assigning the intellectual...

Briefly Noted.
February 9, 2005... Briefly Noted Analogic in Nasdaq compliance Analogic (Peabody, Massachusetts) reported that it has received a determination from Nasdaq that it is now in compliance with requirements for continued listing on the exchange. Analogic said...

2006 budget plan provides 4.5% increase to the FDA.
February 9, 2005... 2006 budget plan provides 4.5% increase to the FDA The FDA's share of President George Bush's proposed budget for fiscal 2006 is $1.9 billion, including $1.5 billion in budget authority and $382 million in congressionally authorized...