Medical Device Week articles from July 2007

Medical Device Week archives from July 2007

CryoCor, Boston Sci ink deal for AF treatment development.
July 2, 2007... Follow-on to panel approval CryoCor, Boston Sci ink deal for AF treatment development By MARK McCARTY Medical Device Daily Washington Editor CryoCor (San Diego) wasted li ttle time in harvesting the fruits of its hard-won...

IMI wins 510(k) clearance for BinaxNOW rapid malaria test.
July 2, 2007... IMI wins 510(k) clearance for BinaxNOW rapid malaria test By KAREN YOUNG Medical Device Daily Staff Writer Men and women serving in the U.S. military abroad -- and who may be active in areas where malaria is endemic -- will now...

International report.
July 2, 2007... International report HemoBioTech eyes India market for blood substitute product A Medical Device Daily Staff Report HemoBioTech (Dallas) said it has engaged Paragon Biomedical (Irvine, California), a contract research organization,...

St. Jude's QuickOpt approved for CRT-P in U.S. and Europe.(St. Jude Medical )(Cardiac Resynchronization Therapy Pacemaker )
July 2, 2007... St. Jude's QuickOpt approved for CRT-P in U.S. and Europe By AMANDA PEDERSEN Medical Device Daily Staff Writer St. Jude Medical (St. Paul, Minnesota) on Friday reported U.S. and European regulatory approvals to expand the...

Deals roundup.
July 2, 2007... Deals roundup IMI completes Biosite acquisition; ATS finalizes CryoCath unit buy A Medical Device Daily Staff Report Inverness Medical Innovations (IMI; Waltham, Massachusetts) reported the successful completion of its acquisition...

Washington roundup.
July 2, 2007... Washington roundup AdvaMed report questions MedPac survey findings on imaging use A Medical Device Daily Staff Report The Advanced Medical Technology Association (AdvaMed; Washington) has released a report that questions the...

Grants/contracts.(Company overview)
July 2, 2007... Grants/contracts Covenant Health inks three-year contract for Safety-Sponge system A Medical Device Daily Staff Report Patient Safety Technologies (PST; Los Angeles) reported that Covenant Health (Lubbock, Texas), a hospital in...

Financings roundup.
July 2, 2007... Financings roundup AppliFlex gets strategic funding; Invacare extends note exchange A Medical Device Daily Staff Report AppliFlex (Nashville, Tennessee)), a privately held start-up company developing laser vapor deposition (LVD),...

Briefly Noted.
July 2, 2007... Briefly Noted Aurora Imaging introduces reimbursement hotline Aurora Imaging Technology (North Andover, Massachusetts) reported the formal launch of the Aurora Breast MRI reimbursement hotline. An example of key services offered...

Product Briefs.
July 2, 2007... Product Briefs * ArthroCare (Austin, Texas) said it has received FDA clearance for its Cavity SpineWand to reduce malignant lesions within the vertebrae. The Cavity SpineWand is used in a minimally-invasive, surgical procedure to actually...

People in Places.
July 2, 2007... People in Places * Abbott Spine (Austin, Texas) reported two new additions to its staff. Richard Minfelde was named a director of new technologies and product development. Previously, Minfelde was with Spine Vision as director of R&D....

Holiday notice.
July 3, 2007... Holiday notice The offices of Medical Device Daily will be closed on Wednesday because of the July 4th holiday in the U.S. The next issue of MDD will be published July 5. SOURCE-Medical Device Daily

FDA okays Spectranetics' Turbo-Booster for blocked leg arteries.
July 3, 2007... FDA okays Spectranetics' Turbo-Booster for blocked leg arteries By AMANDA PEDERSEN Medical Device Daily Staff Writer In less than 60 days after submitting its application, Spectranetics (Colorado Springs, Colorado) said it has...

West Michigan manufacturers organize in bid to boost sales.(Company overview)
July 3, 2007... West Michigan manufacturers organize in bid to boost sales By JOHN BROSKY Medical Device Daily Contributing Writer GRAND RAPIDS, Michigan -- With a goal of doubling sales volumes over the next five years, seven manufacturers of...

Report from Europe.
July 3, 2007... Report from Europe NMT's BioSTAR technology receives CE-mark approval A Medical Device Daily Staff Report NMT Medical (Boston) reported receiving CE-mark approval in Europe for its BioSTAR bioabsorbable septal repair implant...

Bariatric market big enough for a variety of new entrants.
July 3, 2007... 1st of 2 stories Bariatric market big enough for a variety of new entrants By DIANA TUCKER Medical Device Daily Contributing Writer SAN DIEGO -- About 20 million Americans would qualify for insurance coverage for bariatric...

Deals roundup.
July 3, 2007... Deals roundup TPG finalizes $945M purchase of HealthSouth's Surgery Division A Medical Device Daily Staff Report The Texas Pacific Group (TPG; San Francisco/London) reported that it finalized its previously disclosed transaction...

Financings roundup.
July 3, 2007... Financings roundup pSivida to raise $18M in offering; Reflect closes funding of $2.5M A Medical Device Daily Staff Report pSivida (Perth, Australia) reported that it entered into definitive agreements to raise about $18 million...

Neurothrombectomy guidance not seen as news by industry insiders.
July 3, 2007... Neurothrombectomy guidance not seen as news by industry insiders By MARK McCARTY Medical Device Daily Washington Editor FDA has issued a formal guidance on clinical studies and trials for neurothrombectomy devices, but at least one...

Court report.
July 3, 2007... Court report E-Z-EM says patent suit filed against it by Tyco Healthcare A Medical Device Daily Staff Report E-Z-EM (Lake Success, New York) said that the Tyco Healthcare Group, part of Tyco International (Pembroke, Bermuda), had...

Grants/contracts.
July 3, 2007... Grants/contracts NAS renews three-year contract for Premier brachytherapy sources A Medical Device Daily Staff Report North American Scientific (Chatsworth, California) reported the renewal of a new three-year contract with Premier...

Agreements roundup.
July 3, 2007... Agreements roundup Sysmex enters into pact with BIM to distribute device A Medical Device Daily Staff Report Sysmex (Kobe, Japan) reported Monday an agreement with bioMerieux (BIM; Paris) to distribute Sysmex's UF-100i urinalysis...

Product Briefs.
July 3, 2007... Product Briefs * Boston Scientific (Natick, Massachusetts) reported the launch of the Precision Plus spinal cord stimulation system (SCS), a rechargeable SCS neuromodulation device for the treatment of chronic pain of the trunk, back and...

People in Places.
July 3, 2007... People in Places * Lincoln Smith was named president/CEO of Altarum Institute (Ann Arbor, Michigan). Smith previously served as Altarum's COO and replaces retiring CEO Kenneth Baker. Altarum Institute is a nonprofit research institution,...

New trial aims to EASE breathing for advanced emphysema patients.
July 5, 2007... New trial aims to EASE breathing for advanced emphysema patients By AMANDA PEDERSEN Medical Device Daily Staff Writer Patients who have been diagnosed with advanced widespread emphysema and whose only current option is to wait for...

New Jersey rapidly becoming hub for new biotech companies.
July 5, 2007... New Jersey rapidly becoming hub for new biotech companies By OMAR FORD Medical Device Daily Staff Writer A little more than 10 years ago, New Jersey was hardly what one would call a thriving market for biotech companies. Boasting a...

Report from Europe.
July 5, 2007... Report from Europe Israeli firm given CE marks for biliary, uretral stents A Medical Device Daily Staff Report Allium Group (Caesarea, Israel), a maker of stents for the urinary, gastrointestinal, pulmonary and peripheral vascular...

New gastric bypass procedures address the fears of surgery.
July 5, 2007... 2nd of 2 stories New gastric bypass procedures address the fears of surgery By DIANA TUCKER Medical Device Daily Contributing Writer SAN DIEGO -- If the least-invasive surgical procedure, gastric banding, produces enough...

Patent watch.
July 5, 2007... Patent watch Diomed victorious in EVLT suit vs. Vascular Solutions, AngioDynamics A Medical Device Daily Staff Report Diomed Holdings (Andover, Massachusetts), a developer and marketer of minimally invasive medical technologies,...

Financings.
July 5, 2007... Financings Paracor gets $44.35M in Series D for PEERLESS-HF trial of HeartNet A Medical Device Daily Staff Report Paracor Medical (Sunnyvale, California), a private venture-backed company developing device-based treatments for...

HHS, DOJ team up to crack down on Sunbelt Medicare fraud.
July 5, 2007... HHS, DOJ team up to crack down on Sunbelt Medicare fraud A Medical Device Daily Staff Report Fraudulent billings have plagued the Medicare program for decades, and with the thousands of entities that bill the Centers for Medicare &...

Deals roundup.
July 5, 2007... Deals roundup Hologic/Cytyc $6.2 billion merger clears U.S. antitrust waiting period A Medical Device Daily Staff Report Hologic (Bedford, Massachusetts) and Cytyc (Marlborough, Massachusetts) reported the expiration of the...

Grants/contracts.
July 5, 2007... Grants/contracts Axela Biosensors to partner with U. of Toronto life sciences project A Medical Device Daily Staff Report Axela Biosensors (Toronto) reported that it will be a commercial partner in the University of Toronto's...

Product Briefs.
July 5, 2007... Product Briefs * CSMG Technologies (Corpus Christi, Texas) reported that its subsidiary, Live Tissue Connect, has filed a 510(K) submission with the FDA for a vessel and duct sealing electrosurgical generator and two sealing instruments....

People in Places.
July 5, 2007... People in Places * Wanda Moebius was named VP of policy communications of AdvaMed (Washington). Moebius most recently served as senior director of communications at the Pharmaceutical Research and Manufacturers of America (PhRMA)....

Tyco Healthcare, now Covidien, spun off from Tyco International.
July 6, 2007... Tyco Healthcare, now Covidien, spun off from Tyco International By OMAR FORD Medical Device Daily Staff Writer After more than a year's worth of planning and preparation, Covidien, formerly known as Tyco Healthcare (both Mansfield,...

ARIC study indicates PLAC test can assess risk of stroke.
July 6, 2007... ARIC study indicates PLAC test can assess risk of stroke By KAREN YOUNG Medical Device Daily Staff Writer Thinking that stroke is something one's parents or grandparents are most likely to suffer, rather than the middle-aged, is...

Report from Europe.
July 6, 2007... Report from Europe 1st patients enrolled in trial on safety of Reva's new stent A Medical Device Daily Staff Report Reva Medical (San Diego) reported enrollment of the first patients in a first-in-man clinical trial designed to...

SPORT trial arms mixes signals as to best therapies for back.
July 6, 2007... SPORT trial arms mixes signals as to best therapies for back By MARK McCARTY Medical Device Daily Washington Editor If Shakespeare had known Hippocrates, Hamlet might have tormented himself with the question: "To operate or not to...

Deals roundup.
July 6, 2007... Deals roundup CardioTech selling Gish for $7.5M; Manor Care goes private for $6.3B A Medical Device Daily Staff Report CardioTech International (Wilmington, Massachusetts), a developer of advanced materials and medical devices for...

Financings roundup.
July 6, 2007... Financings roundup AIO raises $16M in initial public offering through London's AIM A Medical Device Daily Staff Report AIO Medical (Orlando, Florida) a small orthopedic company developing medical devices for the spine and trauma...

Agreements roundup.
July 6, 2007... Agreements roundup Scivanta in pacts with Ethox, ASG, for Hickey Cardiac Monitoring A Medical Device Daily Staff Report Scivanta Medical (Spring Lake, New Jersey) reported that it has entered into development agreements with Ethox...

New ventures.
July 6, 2007... New ventures Raytel launches CardioCare for quality care of arrhythmia patients A Medical Device Daily Staff Report Raytel Cardiac Services (Windsor, Connecticut) reported the full launch of its newly designed CardioCare...

Patent watch.
July 6, 2007... Patent watch SonoSite files counterclaim to GE's patent suit filed in May A Medical Device Daily Staff Report SonoSite (Bothell, Washington), which focuses on hand-carried ultrasound, said it is filing a patent infringement lawsuit...

Product Briefs.
July 6, 2007... Product Briefs * K2M (Leesburg, Virginia) reported the launch of its Range spinal system. This system combines the newest versions of the MESA and DENALI spinal systems and includes instruments designed to enhance the surgeon's ability to...

People in Places.
July 6, 2007... People in Places o Allied Healthcare International (New York) reported that Timothy Aitken has resigned from his positions as CEO and chairman of the board. The company said it will announce arrangements for the interim management...

AMO trumps Warburg Pincus via late $4.3 billion play for B&L.
July 9, 2007... AMO trumps Warburg Pincus via late $4.3 billion play for B&L By HOLLAND JOHNSON Medical Device Daily Managing Editor Advanced Medical Optics (AMO; Santa Ana, California) surprised many on the Street lasat week with its 11th hour...

Financings roundup.
July 9, 2007... Financings roundup Aspect exercises option to buy back shares from Boston Sci A Medical Device Daily Staff Report Aspect Medical Systems (AMS; Norwood, Massachusetts) reported that it has exercised an option to purchase 2.5 million...

International report.
July 9, 2007... International report Medusa software implemented in Nova Scotia pilot program A Medical Device Daily Staff Report Medusa Medical Technologies (Halifax, Nova Scotia) said that its flagship electronic patient care reporting software,...

Washington roundup.
July 9, 2007... Washington roundup New Jersey court to hear suits over NuvaRing adverse events By MARK McCARTY Medical Device Daily Washington Editor Congress may have backed off the idea of scuttling FDA's pre-emption of state court lawsuits...

Still holding out for Bioenvision.
July 9, 2007... Still holding out for Bioenvision Genzyme's Hylastan fizzles; Synvisc-One efforts continue By Randall Osborne Medical Device Daily West Coast Editor With approval pending in the U.S. — and soon in Europe — for...

Deals roundup.
July 9, 2007... Deals roundup Ventas negotiates plan to spin off hospital to University of Kentucky A Medical Device Daily Staff Report Ventas (Louisville, Kentucky) reported that the executive committee of the University of Kentucky (UK;...

Patent watch.
July 9, 2007... Patent watch Ciphergen to pay $600,000 to settle suit with Health Discovery A Medical Device Daily Staff Writer Health Discovery (Savannah, Georgia) reported that its patent infringement action against Ciphergen Biosystems...

Briefly Noted.
July 9, 2007... Briefly Noted Implant Sciences to reduce staff Implant Sciences (Wakefield, Massachusetts) reported that it had completed the first phase of its plans for exiting the radioactive prostate seeds business, which included a major...

Product Briefs.
July 9, 2007... Product Briefs • Dynatronics (Salt Lake City) reported that it has begun shipping the new Dynatron X5 soft tissue oscillation therapy unit. The X5 creates an electrostatic field within the patient, resulting in a highly effective...

People in Places.
July 9, 2007... People in Places • Declan Daly has been appointed COO for Isolagen (Exton, Pennsylvania). Previously Daly served as CFO/executive VP at Inamed. Isolagen is an aesthetics and therapeutics company. • Robert Moore has been named...

CDC ambulatory statistics for '05 underline pressures on EDs.(Centers for Disease Control and Prevention)(emergency departments)
July 10, 2007... CDC ambulatory statistics for '05 underline pressures on EDs By KAREN YOUNG Medical Device Daily Staff Writer The information contained in the Centers for Disease Control and Prevention's (Atlanta) "Ambulatory Medical Care...

Cook's Resten-MP trial is newest challenge to DES technology.
July 10, 2007... Cook's Resten-MP trial is newest challenge to DES technology By OMAR FORD Medical Device Daily Staff Writer Is the drug-eluting stent (DES) in more trouble? That could be the case, according to a new study just unveiled by...

Report from Europe.
July 10, 2007... Report from Europe EC and U.S. agree on cosmetic, medical device confidentiality A Medical Device Daily Staff Report The European Commission (EC) and the FDA have agreed to new confidentiality arrangements, which they say will lead...

Washington roundup.
July 10, 2007... Washington roundup Metasurg has industry 'experts' to deal with FDA warning letter By MARK McCARTY Medical Device Daily Washington Editor FDA in May sent a warning letter to Metasurg (Houston, Texas,) maker of the Ti6...

Financings roundup.
July 10, 2007... Financings roundup TissueLink adds 'E' round $20M; J&J in $10 billion stock buyback A Medical Device Daily Staff Report TissueLink Medical (Dover, New Hampshire), a private company that develops disposable surgical devices that...

Court report.
July 10, 2007... Court Report Tyco's former auditing firm to pay $225 million in settlement A Medical Device Daily Staff Report Pricewaterhouse Coopers (PwC; Trenton, New Jersey) has agreed to pay $225 million to settle a class action lawsuit...

Agreements roundup.
July 10, 2007... Agreements roundup Lifeline Biotech finalizes pact for breast cancer detection system A Medical Device Daily Staff Report Lifeline Biotechnologies (Reno, Nevada) reported that it has finalized an agreement with a First Warning...

Deals roundup.
July 10, 2007... Deals roundup WellPoint acquires AIM for $300M; AeonClad gains coating license A Medical Device Daily Staff Report WellPoint (Indianapolis), one of the nation's largest health benefits providers, reported entering into an...

Patent watch.
July 10, 2007... Patent watch TheraDoc wins two patents for its Expert System Platform technology A Medical Device Daily Staff Report TheraDoc (Salt Lake City), a clinical informatics company that develops and implements real-time electronic...

Product Briefs.
July 10, 2007... Product Briefs • MedAir (Delsbo, Sweden) reported the launch of its OxyCheck fingertip pulse oximeter, a medical monitoring device that performs measurement of oxygen saturation and pulse rate. Features include; durability, the...

People in Places.
July 10, 2007... People in Places • Gregory Browne has been named CFO of Cyberonics (Houston). Most recently, Browne worked with Tatum, an executive services company, and has also founded and served as president of PeopleWorks, a human resource...

TriActiv, ProGuard discontinued, Kensey Nash will save $11.6M.
July 11, 2007... TriActiv, ProGuard discontinued, Kensey Nash will save $11.6M By OMAR FORD A Medical Device Daily Staff Writer Kensey Nash (Exton, Pennsylvania) yesterday reported a plan that would see the company leave the embolic protection...

LapCap cleared for laparoscopy opens new category, says Aragon.
July 11, 2007... LapCap cleared for laparoscopy opens new category, says Aragon By AMANDA PEDERSEN Medical Device Daily Staff Writer No matter how minimally invasive a procedure may be, patients generally don't like the idea of their surgeon...

Report from Europe.
July 11, 2007... Report from Europe Medtronic's Reveal XT device introduced for AF monitoring A Medical Device Daily Staff Report Medtronic (Minneapolis) recently reported the European introduction of Reveal XT, which it described as "the first...

MedApps is now OTC-cleared for diabetes patient monitoring.(over-the-counter)
July 11, 2007... MedApps is now OTC-cleared for diabetes patient monitoring By KAREN YOUNG Medical Device Daily Staff Writer MedApps (Scottsdale, Arizona) is striving ultimately to offer, according to its tagline, "Healthcare Anywhere," and it is...

Deals roundup.(Company overview)
July 11, 2007... Deals roundup CardioTech completes Gish sale; Haemonetics acquires Infonale A Medical Device Daily Staff Writer CardioTech International (Wilmington, Massachusetts), a developer of advanced materials and medical devices for the...

Agreements roundup.
July 11, 2007... Agreements roundup Spinal Restoration partners with Baxter for spinal disc application A Medical Device Daily Staff report Spinal Restoration (Austin, Texas) and Baxter Healthcare (Deerfield, Illinois) said they have entered into...

Financings roundup.
July 11, 2007... Financings roundup SonoSite offers $150M in notes; Light Sciences raises 'B' 30M A Medical Device Daily Staff Report SonoSite (Bothell, Washington), a maker of hand-carried ultrasound devices, reported its intention to offer,...

Grants/contracts.
July 11, 2007... Grants/contracts Guardian, Howard, USC fight breast cancer in African-American women A Medical Device Daily Staff Report Guardian Technologies International (Herndon, Virginia), innovators of threat detection technology with...

Patent watch.
July 11, 2007... Patent watch Signalife awarded U.S. patent for biomedical signal monitoring A Medical Device Daily Staff Report Signalife (Los Angeles) reported that the U.S. Patent and Trademark Office (PTO) has awarded the company a new patent...

Product Briefs.
July 11, 2007... Product Briefs • AtriCure (West Chester, Ohio) reported that its Isolator bipolar ablation clamp system has received FDA clearance for the ablation of cardiac tissue. AtriCure believes that theirs is the only bipolar radio frequency...

People in Places.
July 11, 2007... People in Places • Joseph Smith, MD, PhD, has been named VP of microelectronic technologies for Cordis (Warren, New Jersey) and will lead the company's efforts to develop implantable microelectronic technologies in the management of...

Ventana board calls Roche's $3B offer 'inadequate,' 'high-handed'.(Ventana Medical Systems Inc.)(Roche Holding Ltd.)(briefs)
July 12, 2007... Deals roundup Ventana board calls Roche's $3B offer 'inadequate,' 'high-handed' By HOLLAND JOHNSON Medical Device Daily Managing Editor The board of Ventana Medical Systems (Tucson, Arizona) has rejected the hostile...

S&N's Journey Deuce keeps ACL intact for knee surgery patients.
July 12, 2007... S&N's Journey Deuce keeps ACL intact for knee surgery patients By AMANDA PEDERSEN Medical Device Daily Staff Writer If you have a cavity in one tooth, your dentist is highly unlikely to remove all your teeth. Only that one cavity...

International report.(briefs)
July 12, 2007... International report Former head of China's FDA executed for product problems A Medical Device Daily Staff Report If you're going to take a bribe, best not try that in China. News sources reported this week that China executed...

Washington roundup.
July 12, 2007... Washington roundup CMS publishes final clinical trial rule, still seeks further comment By MARK McCARTY Medical Device Daily Washington Editor The Centers for Medicare & Medicaid Services has published what is unlikely to be...

Financings roundup.
July 12, 2007... Financings roundup Galen closes $250 million fund; SurModics in stent partnership A Medical Device Daily Staff Report Galen Partners (Stamford, Connecticut), a private equity firm focused solely on the healthcare industry, reported...

Patent watch.
July 12, 2007... Patent watch Digilab wins patent for biomarkers for detecting dementia sooner A Medical Device Daily Staff Report Digilab Peptidomics (Hannover, Germany), formerly BioVisioN, was granted a patent by the U.S. Patent and Trademark...