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California Senate panel rejects health coverage plan as 'flawed'.
February 1, 2008... Schwarzenegger vows continued fight
California Senate panel rejects health coverage plan as 'flawed'
By JIM STOMMEN
Medical Device Daily National Editor
A proposal by California Gov. Arnold Schwarzenegger to arrange medical...
Newest data might make more CEOs less doubtful about P4P.(pay-for-performance )
February 1, 2008... Premier report on P4P
Newest data might make more CEOs less doubtful about P4P
By MARK McCARTY
Medical Device Daily Washington Editor
WASHINGTON -- It seems unlikely that everyone bearing the title of CEO for a hospital chain...
Report from Europe.
February 1, 2008... Report from Europe
IsoRay takes 30% stake in new Russian isotope company
A Medical Device Daily Staff Report
IsoRay (Richland, Washington), a manufacturer of brachytherapy seeds for the treatment of prostate cancer and other solid...
Homecare seeks election-year boost in its Medicare funding.
February 1, 2008... One solution to the problem?
Homecare seeks election-year boost in its Medicare funding
By LYNN YOFFEE
Medical Device Daily Staff Writer
Three-quarters of voters polled in a recent survey believe home care is part of the...
Deals roundup.
February 1, 2008... Deals roundup
Affymetrix buying USB for $75M; merger takes NewCardio public
A Medical Device Daily Staff Report
Affymetrix (Santa Clara, California) reported completing its acquisition of USB (Cleveland), a private company...
Today's MDD food for med-tech thought.
February 1, 2008... Today's MDD food for med-tech thought
"The problems... are likely to get worse."
-- California Governor Arnold Schwarzenegger, citing the need for comprehensive health insurance coverage for the state's citizens, "California Senate...
Washington roundup.
February 1, 2008... Washington roundup
CMS proposes stricter standards for DMEPOS suppliers to meet
A Medical Device Daily Staff Report
The Centers for Medicare & Medicaid Services last week issued a proposed rule to enhance the enrollment standards...
FDA wants more information about ATS heart valve PMA.
February 1, 2008... FDA wants more information about ATS heart valve PMA
A Medical Device Daily Staff Report
FDA has asked for more information and clarification regarding a pre-market approval (PMA) application for the ATS 3f aortic bioprosthesis from...
Financings roundup.
February 1, 2008... Financings roundup
Cardium to sell stock and warrants in transaction valued at $5.3M
A Medical Device Daily Staff Report
Cardium Therapeutics (San Diego) reported that it has entered into a purchase agreement with institutional and...
Contracts.
February 1, 2008... Contracts
National Interop is awarded system contract by Air Evac
A Medical Device Daily Staff Report
National Interop (Seattle) reported it has been awarded a project to significantly upgrade the radio system serving air...
Court Report.
February 1, 2008... Court Report
Scripps settlement will reduce payments 35% for uninsured
A Medical Device Daily Staff Report
Kelly Dermody, of the law firm of Lieff Cabraser Heimann & Bernstein, reported the settlement of a class action lawsuit...
Briefly Noted.(Brief article)
February 1, 2008... Briefly Noted
Neurofeedback course coming to Atlanta
EEG Info (Woodland Hills, California) will offer a Clinical Course in Neurofeedback in Atlanta, Feb. 21-24, 2008. The course is taught by industry leaders Siegfried and Sue Othmer,...
People in Places.(Brief article)
February 1, 2008... People in Places
* Thomas Ehardt was named CEO of the Advogent Group (Piscataway, New Jersey). Previously, Ehardt was CEO of The Jobson Publishing Group. Advogent provides communications and educational solutions to the pharmaceutical,...
Kirk to be named Hanger CEO, will replace 17-year vet Sabel.
February 1, 2008... Kirk to be named Hanger CEO, will replace 17-year vet Sabel
A Medical Device Daily Staff Report
Hanger Orthopedic Group (Bethesda, Maryland) said that its board has unanimously approved the recommendation of Chairman/CEO Ivan Sabel for...
Product Briefs.
February 1, 2008... Product Briefs
* Ascension Orthopedics (Austin, Texas) said the Titan humeral resurfacing device is now available to help people who suffer from debilitating shoulder disorders. The company said the Titan "has advanced the concept of...
With FDA approval, Medtronic's Endeavor to get close scrutiny.
February 4, 2008... DES 2.0 era arrives!
With FDA approval, Medtronic's Endeavor to get close scrutiny
By DON LONG Medical Device Daily Executive Editor, and AMANDA PEDERSEN, Medical Device Daily Staff Writer
The second-generation of drug-eluting...
Low- and high-tech innovation among realities of cardio care.
February 4, 2008... With procedural videos abounding...
Low- and high-tech innovation among realities of cardio care
By DON LONG, Medical Device Daily Executive Editor
Society of Thoracic Surgery Annual Meeting
FORT LAUDERDALE, Florida u Roaming...
Report from Europe.
February 4, 2008... Report from Europe
New NICE report clears fog over use of drug-eluting stents in UK
By JOHN BROSKY, Medical Device Daily European Editor
England's influential National Institute for Health and Clinical Excellence (NICE) has...
VascuView represents latest of FDA's Escalon clearances.
February 4, 2008... VascuView represents latest of FDA's Escalon clearances
By OMAR FORD, Medical Device Daily Staff Report
It seems as if Escalon Medical (Wayne, Pennsylvania) has hit the proverbial jackpot for FDA product clearances lately.
The...
Financings roundup.
February 4, 2008... Financings roundup
NorTech reports $318M VC raise; China Sky One raises private $25M
A Medical Device Daily Staff Report
Last year the NorTech Venture Capital Advisory Task Force (Cleveland) reported in its inaugural 2006 Venture...
Today's MDD food for med-tech thought.
February 4, 2008... Today's MDD food for med-tech thought
"This device addresses an important need by demonstrating comparable clinical effectiveness to a first generation drug-eluting stent while also exhibiting a safety profile more typical of a bare-metal...
Deals roundup.
February 4, 2008... Deals roundup
Synovis closes interventional unit sale to Heraeus Vadnis for $29.5M
A Medical Device Daily Staff Report
Synovis Life Technologies (SLT; St. Paul, Minnesota) reported that it has closed on its previously reported...
Agreements.
February 4, 2008... Agreements
Hill-Rom, KCI sign license deal for therapeutic support surface
A Medical Device Daily Staff Report
Hillenbrand Industries (Batesville, Indiana) reported that its Hill-Rom subsidiary, a provider of patient care...
Briefly Noted.(Brief article)
February 4, 2008... Briefly Noted
Animal study to aid AMD research
A Cleveland Clinic (Cleveland) research team has developed the first animal model of age-related macular degeneration (AMD) that will enable researchers to study the development and...
Court report.
February 4, 2008... Court report
Cook Medical seeks cease, desist order against Sapien heart valve
A Medical Device Daily Staff Report
Cook (Bloomington, Indiana) said it has filed suit in a Dusseldorf district court against Edwards Lifesciences...
Contracts.
February 4, 2008... Contracts
Infinisource selects Elite for health management programs
A Medical Device Daily Staff Report
Infinisource (Coldwater, Michigan), a provider of compliance and benefit solutions, has selected Elite Wellness USA (Dallas) to...
People in Places.(Brief article)
February 4, 2008... People in Places
* Applied Spine Technologies (New Haven, Connecticut) has named neurosurgeon Michael Giordano, MD, as its chief medical officer. Most recently, Giordano was a consultant to medical device companies and private equity...
Minerva launches CEO search, launches legal action vs. Czirr.
February 4, 2008... Minerva launches CEO search, launches legal action vs. Czirr
A Medical Device Daily Staff Report
Minerva Biotechnologies (Waltham, Massachusetts) said that it will be recruiting a new CEO following the board's termination of its...
Product Briefs.(Brief article)
February 4, 2008... Product Briefs
* Healthcare Providers Direct (Lawrenceville, New Jersey) reported the release of ImmunoDip, a rapid screening test to detect microalbuminuria, an early indicator of chronic kidney disease in diabetic patients....
EPIX, FDA reach agreement on image re-read of Vasovist.(Brief article)
February 4, 2008... EPIX, FDA reach agreement on image re-read of Vasovist
A Medical Device Daily Staff Report
EPIX Pharmaceuticals (Lexington, Massachusetts) reported that it has reached an agreement with the FDA on its proposal for the re-read of images...
Evidence pushes possible CMS artificial heart reimbursement.
February 5, 2008... Evidence pushes possible CMS artificial heart reimbursement
By AMANDA PEDERSEN
Medical Device Daily Staff Writer
The Centers for Medicare & Medicaid Services said yesterday it might reimburse the use of artificial heart devices for...
Comparative effectiveness data positive, but require careful use.
February 5, 2008... 2008 National Health Policy Conference
Comparative effectiveness data positive, but require careful use
By MARK McCARTY
Medical Device Daily Washington Editor
WASHINGTON -- Comparative effectiveness studies are receiving...
Report from Europe.
February 5, 2008... Report from Europe
Software bugs delay start of Munich proton therapy center
By JOHN BROSKY
Medical Device Daily European Editor
Varian Medical Systems (Palo Alto, California) is struggling to commission Europe's first...
Financings roundup.
February 5, 2008... Financings roundup
Transoma prices $54M IPO;Peak raises $21M in 'C' round
By OMAR FORD
Medical Device Daily Staff Writer
Transoma Medical (St. Paul, Minnesota) reported pricing an IPO valued at up to $54 million for 4 million...
Midwest startups reach $1.2B in '07; no slowdown is seen.
February 5, 2008... Midwest startups reach $1.2B in '07; no slowdown is seen
By ROB KIMBALL
Medical Device Daily Staff Writer
While the heartland of America is waiting to thaw out, the venture capital startup market has continued to burn with...
Today's MDD food for med-tech thought.
February 5, 2008... Today's MDD food for med-tech thought
"'Wrong' doesn't begin to describe his actions."
-- Lawrence McAndrews, of the National Association of Children's Hospitals, commenting on President Bush's proposed cut of the CHGME program,...
Deals roundup.
February 5, 2008... Deals roundup
B&L completes buy of eyeonics; Molecular Vision stake acquired
A Medical Device Daily Staff Report
Bausch & Lomb (B&L; Rochester, New York) reported completing the acquisition of eyeonics (Aliso Viejo, California),...
Washington roundup.
February 5, 2008... Washington roundup
President cuts children's GME program with budget request
A Medical Device Daily Staff Report
President Bush's FY09 budget request, recently released, eliminates all funding for a children's hospitals program...
Briefly Noted.(Telemedicus joined with BioHouston)(Brief article)
February 5, 2008... Briefly noted
Telemedicus joins BioHouston
Telemedicus (Houston) said it has joined BioHouston, an organization that provides a platform to stimulate commercialization of emerging advances from the research sector.
Telemedicus is...
Proton therapy gets boost from German radiation law.
February 5, 2008... Proton therapy gets boost from German radiation law
Proton therapy received a big boost in Germany with a decision enforcing a very strict radiation protection law which says that if two methods are available for treating a tumor, then the...
Agreements.
February 5, 2008... Agreements
Beaumont to do tubing, catheter misconnection errors testing
A Medical Device Daily Staff Report
The Beaumont Technology Usability Center (BTUC; Royal Oak, Michigan) said it will begin research on the next phase of the...
Product Briefs.
February 5, 2008... Product Briefs
* Kinetic Concepts (KCI; San Antonio) has introduced a new mattress replacement system (MRS), the AtmosAir V-series MRS, designed to assist hospitals in the prevention and treatment of pressure ulcers. According to the...
People in Places.(briefs)
February 5, 2008... People in Places
* Scott Mahnken has been named director of marketing at Milestone Scientific (Livingston, New Jersey). Mahnken previously was director of partnership relations at ArcMesa Educators. Milestone is the developer of CompuFlo,...
House, Senate staffers see little change in healthcare this year.
February 6, 2008... The healthcare 'elephant' in the room... outcries from many
2008 National Health Policy Conference
House, Senate staffers see little change in healthcare this year
By MARK McCARTY
Medical Device Daily Washington Editor
...
Washington roundup.
February 6, 2008... The healthcare 'elephant' in the room... outcries from many
Washington roundup
New Bush budget proposal could cut up to $2 billion from HHS
By HOLLAND JOHNSON
Medical Device Daily Managing Editor
President Bush's new $3...
Minimally invasive back pain treatment to get CMS review.
February 6, 2008... Minimally invasive back pain treatment to get CMS review
By LYNN YOFFEE
Medical Device Daily Staff Writer
The Centers for Medicare & Medicaid Services has reported that it has opened a national coverage determination (NCD) for a...
Supercomputer used in Canadian study to simulate heart activity.
February 6, 2008... Supercomputer used in Canadian study to simulate heart activity
By AMANDA PEDERSEN
Medical Device Daily Staff Writer
In an effort to better understand cardiac and other illnesses, researchers from the Universite de Montreal (UdeM)...
Deals roundup.
February 6, 2008... Deals roundup
General Electric to purchase Whatman for $717 million
A Medical Device Daily Staff Report
General Electric (Fairfield, Connecticut) reported that it has agreed to buy Whatman (London), the maker of DNA-based products...
Today's MDD food for med-tech thought.
February 6, 2008... Today's MDD food for med-tech thought
"The amount in the administration's proposed budget is not only inadequate, it is barely half of what FDA needs just to keep pace with inflation."
-- William Hubbard, a spokesman for The Alliance...
Financings roundup.
February 6, 2008... Financings roundup
IPC raises $45.8 million in its IPO; Abbott to invest up to $40M in Ibis
A Medical Device Daily Staff Report
IPC The Hospitalist Company (North Hollywood, California), a provider of hospitalist services, said it...
Court report.
February 6, 2008... Court report
Bayonne Medical Center in $2.5M settlement for defrauding claims
A Medical Device Daily Staff Report
The United States has agreed to settle for $2.5 million, plus interest, allegations that Bayonne Medical Center...
International report.
February 6, 2008... International report
CardioDynamics signs accord with equipment firm in India
A Medical Device Daily Staff Report
CardioDynamics (San Diego), developer of the Impedance Cardiography (ICG) technology, reported a strategic alliance...
Boston Sci 4Q08 gains obscured by $458M Guidant-related losses.
February 6, 2008... Boston Sci 4Q08 gains obscured by $458M Guidant-related losses
A Medical Device Daily Staff Report
Boston Scientific (Natick, Massachusetts) reported a $458 million 4Q08 loss brought on, it said, by short-term efforts to reduce debt...
Briefly Noted.(Touch Bionics Inc open a new facility)(Brief article)
February 6, 2008... Briefly Noted
Touch Bionics incorporates in U.S.
Touch Bionics (Boston) reported its incorporation in the U.S. as Touch Bionics Inc. Currently basing U.S. operations out of Boston, following the company's opening of its new...
Agreements.
February 6, 2008... Agreements
WaferGen in pact to distribute cell imaging technology
A Medical Device Daily Staff Report
WaferGen Biosystems (Fremont, California), a developer of gene expression, genotyping, cell biology and stem cell research...
Product Briefs.
February 6, 2008... Product Briefs
* CytoCore (Chicago) said that FDA has approved the company's 510(k) clearance for its SoftPAP cervical cell collector. The company said that the SoftPAP "collects more comprehensive and complete cervical cell specimens for...
People in Places.(briefs)(Brief article)
February 6, 2008... People in Places
* The California Healthcare Institute (CHI; La Jolla, California) has appointed Sandra Pizarro as VP of state government affairs. For the past four years, Pizarro has worked as a lobbyist for KP Public Affairs. CHI is a...
Leavitt: '09 health budget cuts vital to avoid CMS bankruptcy.(Health and Human Services Secretary Michael Leavitt)
February 7, 2008... Leavitt: '09 health budget cuts vital to avoid CMS bankruptcy
By MARK McCARTY
Medical Device Daily Washington Editor
WASHINGTON -- Rumor is that the 2009 White House budget proposal for the Department of Health and Human Services...
Panel: data lacking for tracking costs of med-tech on economy.
February 7, 2008... 2008 National Health Policy Conference
Panel: data lacking for tracking costs of med-tech on economy
By MARK McCARTY
Medical Device Daily Washington Editor
WASHINGTON -- The impact of medical devices on the cost of healthcare...
Report from Europe.
February 7, 2008... Report from Europe
French ortho implant developer gets $9 million to push exports
By JOHN BROSKY
Medical Device Daily European Editor
and MDD Staff Reports
French orthopedic implant maker Dedienne Sante (Mauguio) has...
AHRQ: no one prostate cancer treatment better than another.(Agency for Healthcare Research and Quality )
February 7, 2008... 'Overdetection' and 'overtreatment'?
AHRQ: no one prostate cancer treatment better than another
By DON LONG
Medical Device Daily Executive Editor
The Agency for Healthcare Research and Quality (AHRQ) may be one of the more...
Financings roundup.
February 7, 2008... Financings roundup
Transoma postpones IPO due to 'unfavorable market conditions'
A Medical Device Daily Staff Report
Transoma Medical (St. Paul, Minnesota) reported yesterday that it is postponing its initial public offering,...
Today's MDD food for med-tech thought.
February 7, 2008... Today's MDD food for med-tech thought
"American sensitivity to entitlement warnings has become numbed by a repeated cycle of alarms and inaction."
-- Michael Levitt, HHS secretary, warning that CMS on its current path will be "broke"...
Deals roundup.(BG Medicine and ACS Biomarker entered into a licensing agreement)(Vermillion Inc. renews licensing agreement with Johns Hopkins University )
February 7, 2008... Deals roundup
BG, ACS in diagnostic accords; Vermillion renews collaboration
A Medical Device Daily Staff Report
BG Medicine (Waltham, Massachusetts) and ACS Biomarker (Maastricht, the Netherlands) reported that they have entered...
Grants/contracts.
February 7, 2008... Grants/contracts
DARPA issues contract to develop prosthetic limb to Johns Hopkins
A Medical Device Daily Staff Report
The Johns Hopkins University Applied Physics Laboratory (Laurel, Maryland) has received a contract from the...
Patent watch.(Brief article)
February 7, 2008... Patent watch
Vasomedical's wins added U.S. IP for EECP cuff pressure control
A Medical Device Daily Staff Report
Vasomedical (Westbury, New York) reported that it has received a U.S. patent for technology that automatically...
Court report.(Brief article)
February 7, 2008... Court report
Synthes Spine under scrutiny for ProDisc device disclosures
A Medical Device Daily Staff Report
The New Jersey attorney general's office reported that it has issued subpoenas to Synthes Spine (Zurich,Switzerland) and...
Agreements.
February 7, 2008... Agreements
NHC in pact with McKendree to provide management services
A Medical Device Daily Staff Report
National HealthCare Corporation (NHC; Murfreesboro, Tennessee) an operator of senior care services reported that it has...
Product Briefs.
February 7, 2008... Product Briefs
* T2 Biosystems (Cambridge, Massachusetts) reported research findings that support the advancement and development of nanoparticle-based, MR technology that offer rapid, portable diagnostic testing. This research, it said,...
St. Jude says software upgrade corrects Epic, Atlas problems.
February 7, 2008... St. Jude says software upgrade corrects Epic, Atlas problems
A Medical Device Daily Staff Report
St. Jude Medical (St. Paul, Minnesota) reported that it has distributed a programmer software upgrade to eliminate a random, low-frequency...
People in Places.(Brief article)
February 7, 2008... People in Places
* Hooper Holmes (Basking Ridge, New Jersey) reported that James Calver has resigned from his positions as the president/CEO of the company, and as a member of the board. The board has named Roy Bubbs to serve as the...
Washington roundup.
February 8, 2008... Washington roundup
Senate eyeing patent reform bill as White House remains wary
By MARK McCARTY
Medical Device Daily Washington Editor
U.S. patent reform has been on Congress's plate for the past couple of years, but a...
Deals roundup.
February 8, 2008... Deals roundup
MBF to buy CHS for $420 million; Enigma licenses Applera patents
A Medical Device Daily Staff Report
MBF Healthcare Acquisition (MBH; Coral Gables, Florida), a publicly traded special purpose acquisition company,...
Report from Europe.
February 8, 2008... Report from Europe
Zimmer planning manufacturing addition for Shannon, Ireland
A Medical Device Daily Staff Report
Global orthopedics giant Zimmer Holdings (Warsaw, Indiana) reported plans to expand its global manufacturing network...
NeoMedix device 'unclogs' drain in the eye to prevent glaucoma.
February 8, 2008... NeoMedix device 'unclogs' drain in the eye to prevent glaucoma
By ROB KIMBALL
Medical Device Daily Staff Writer
It's never very comfortable to get one of those eye exams, the one where they puff a jet of air into your eye, to...
Patent watch.
February 8, 2008... Patent watch
AIPPI sides with Occlutech in AGA infringement claim
A Medical Device Daily Staff Report
Occlutech (Jena, Germany), a manufacturer of coronary occlusion devices said it has obtained approval for its IP position in...
Today's MDD food for med-tech thought.(Brief article)
February 8, 2008... Today's MDD food for med-tech thought
"The shift is toward shared information systems with patients and families, where patients and families can put their own information in there, their observations, their tracking, documenting things...
Agreements.(Clinical report)
February 8, 2008... Agreements
U.S. Army testing Vicor's tech to assess injured, ill soldiers
By LYNN YOFFEE
Medical Device Daily Staff Writer
The U.S. Army has signed a Collaborative Research and Development Agreement with Vicor Technologies...
Around the Beltway.
February 8, 2008... Around the Beltway
PHR use to be studied for ability to help deal with hypertension
A Medical Device Daily Staff Report
Personal health record (PHR) systems are being pushed as alternatives for maintaining... well, personal health...
Contracts.
February 8, 2008... Contracts
Pennsylvania expects to save $55M with PHS contract extension
A Medical Device Daily Staff Report
Attempting to save taxpayers $55 million and safeguard the continuity of medical care for Pennsylvania's 46,000 inmates,...
Briefly Noted.
February 8, 2008... Briefly Noted
Blue Shield to pay for psoriasis device
PhotoMedex (Montgomeryville, Pennsylvania) said that Blue Shield of California has adopted a medical policy approving payment for medically necessary treatment of mild to moderate...
Product Briefs.
February 8, 2008... Product Briefs
* American Bio Medica (ABMC; Kinderhook, New York) said that it has commenced manufacturing diagnostic test strips for Syphilis for Hema Diagnostic Systems (HDS; Miami Beach, Florida), a privately held manufacturer of rapid...
People in Places.
February 8, 2008... People in Places
* Aerocrine AB (Solna, Sweden) reported the appointment of Chip Neff to the position of president of Aerocrine's U.S. subsidiary Aerocrine Inc. (Chicago), effective Feb. 25. Neff joins Aerocrine from HemoCue/Quest...
Allergan's Botox, Myobloc from Solstice under 'review' by FDA.
February 11, 2008... Allergan's Botox, Myobloc from Solstice under 'review' by FDA
By DON LONG
Medical Device Daily Executive Editor
And AMANDA PEDERSEN
Medical Device Daily Staff Writer
In apparent response to reports of deaths associated...