Alsius Corporation Announces Agreement to Sell Assets to ZOLL Medical Corporation

IRVINE, Calif., Feb. 20 (HSMN NewsFeed) -. Alsius Corporation (Nasdaq: ALUS ) announced today that it has signed an agreement with a wholly- owned subsidiary of ZOLL Medical Corporation (Nasdaq: ZOLL ) under which Alsius will sell to ZOLL substantially all the assets constituting Alsius' intravascular temperature management device business for a purchase price of $12 million in cash. The assets to be acquired include the intellectual property relating to the business, other intangibles, inventories and fixed assets. The closing of the transaction is subject to customary closing conditions.

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Bovie Medical Corporation Reports Success with Seer Tissue Resection Device Sales and Marketing

MELVILLE, N.Y.--(HSMN NewsFeed)--Bovie Medical Corporation (the “Company”) (NYSE Alternext US: BVX), a manufacturer and marketer of electrosurgical products, today announced that the Company has completed numerous successful surgical procedures with its SEER tissue resection device in France, Italy, Belgium, Spain and in the United States. Sales of the product have commenced in both the U.S. and abroad.

The SEER utilizes RF energy and saline together with Bovie’s proprietary technology to create a distinct clinical effect that has been initially used in solid organ resection to cut tissue and limit blood loss while improving surgeon visibility and patient outcomes.

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Cardo Medical Announces Femur-First Versatility With Its Uni-Compartmental Knee System

LOS ANGELES, CA--(HSMN NewsFeed)--Feb 18, 2009 -- Cardo Medical (OTC BB:CDOM.OB ), a company engaged in the development of orthopedic medical devices, announces the femur-first versatility in surgical technique with its Uni-Compartmental Knee System. Uni-compartmental knee arthroplasty procedures are most commonly performed using tibial-first referencing surgical techniques; however the Cardo Medical Uni-Compartmental Knee system also provides surgeons with additional intra-operative versatility to easily adapt to femur-first surgical techniques. Dr. Andrew Yun, an orthopedic surgeon at St. John's Hospital in Santa Monica, CA, has performed numerous femur-first uni-compartmental arthroplasty procedures and commented, "I have been very satisfied with the ease of use and outcomes with this system. The Cardo engineering team has been incredible to work with, and I have enjoyed the responsiveness and quality of work which comes from this group." In addition, Dr. Jonathan Braslow, an orthopedic surgeon at JFK Memorial Hospital in Indio, CA, also stated, "The Cardo Align 360 instrumentation system eliminates the guesswork for the first cut, the system was easy and simple to use and creates a reproducible outcome each time." The Align 360 Uni-Compartmental Knee System, Cardo Medical's initial product release, has been used successfully since its introduction in January 2007. System enhancements for the femur-first approach include novel, unique femoral tibial alignment ("knee jack") instruments with dedicated alignment and resection guides.

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Power Medical Interventions Receives FDA 510(k) Marketing Clearance for i60RL Intelligent Surgical Instruments(tm)

LANGHORNE, Pa., Feb. 17, 2009 (GLOBE NEWSWIRE) -- Power Medical Interventions(r), Inc. (NasdaqGM:PMII - News), a leader in developing and commercializing Intelligent Surgical Instruments(tm), announced today that the U.S. Food and Drug Administration has cleared its 510(k) application for marketing its patented i60RL Intelligent Surgical Instrument. The i60RL Intelligent Surgical Instrument is the world's first reverse pivot linear cutter, designed to improve medical outcomes by providing surgeons with greater access to important anatomical sites that are currently difficult to reach. The i60RL will be available for applications throughout the digestive tract. The Company intends to launch the product in April 2009.

Full article >> http://www.devicespace.com/news_story.aspx?NewsEntityId=126503

Syneron(TM) Partners With the American Academy of Cosmetic Physicians (AAOCP) to Train LipoLite(TM) and Laser LipoSculpture Physicians

LipoLite Customers Receive Complimentary AAOCP Membership With PurchaseIRVINE, CA--(HSMN NewsFeed)--Feb 17, 2009 -- Syneron(TM) Medical Ltd. (NasdaqGS:ELOS ), an innovator in the development, marketing and sales of elos(TM) combined-energy medical aesthetic devices, today announces a partnership with the American Academy of Cosmetic Physicians (AAOCP) to support laser liposculpture courses for Syneron's LipoLite(TM) laser-assisted liposuction device. The AAOCP is an organization of physicians who have successfully integrated aesthetic procedures into their practice. The AAOCP is dedicated to enhanced clinical training and safety and the exchange of best practices and ideas.

As part of the partnership, the AAOCP will train new Syneron LipoLite physicians and refer physicians to LipoLite as a preferred laser-assisted liposuction device. Syneron will offer all LipoLite customers complimentary membership into the AAOCP and recommend AAOCP to physicians for training.

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Bard Receives FDA Approval for the LifeStent Vascular Stent

MURRAY HILL, N.J.--(HSMN NewsFeed)--C. R. Bard, Inc., (NYSE: BCR ) today announced that it has received Pre-Market Approval (PMA) from the United States Food and Drug Administration to market the LifeStent® FlexStar and FlexStar XL Vascular Stent Systems. The devices are approved for the treatment of occlusive disease in native superficial femoral arteries (SFA) and proximal popliteal arteries, and are marketed by the Bard Peripheral Vascular Division, located in Tempe, Arizona.

Two-year clinical data on the LifeStent® vascular stent demonstrated a freedom from target lesion revascularization rate of 78% vs. 42% (p<.0001) for percutaneous transluminal angioplasty alone. In addition, the device exhibited a low fracture rate of 3.8% at 18 months. Dr. Barry Katzen, M.D., founder and medical director of Baptist Cardiac & Vascular Institute and co-principal investigator of the LifeStent® RESILIENT trial, commented, “The long-term data recently presented are important because they demonstrate the sustained performance of the LifeStent® vascular stent. Of particular significance to clinicians and patients is the approval of the 170mm stent, the longest commercially available in the United States. Henceforth, long and diffuse lesions presenting in the SFA can be effectively treated with a single stent, which should help improve both clinical outcomes and procedural costs.”

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Cardinal Health Announces New Name for Spinoff Company

DUBLIN, Ohio, Feb. 16 (HSMN NewsFeed) -- Cardinal Health, a global provider of products and services that improve the safety and productivity of health care, has selected a name for the medical technology company that will be formed through the proposed spinoff of its Clinical and Medical Products businesses.

The new company will be named CareFusion®, reflecting a diverse blend of medical technologies the company will offer to improve the safety and quality of care. From infusion and medication safety technologies to respiratory equipment, automated medical supply dispensing and infection prevention offerings, CareFusion® will be the largest medical technology company with a singular focus on patient safety. The new company expects to trade on the New York Stock Exchange under the ticker symbol CFN.

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Aesthetic Sciences Announces European Clearance to Market Breakthrough Dermal Filler Delivery System

MENLO PARK, Calif.--(BUSINESS WIRE)--February 12, 2009--Aesthetic Sciences announced today that it has received the CE Mark for its breakthrough dermal filler delivery system, the Smartfil™ Power-assisted Injection System. The CE Mark provides clearance for sales throughout Europe. The Smartfil™ system is the first powered device approved to be used with dermal fillers and the first product in the new category of power-assisted injection systems. In clinical studies with 100 patients and 25 doctors, this system demonstrated unique benefits to the injection process.
The company believes the controlled and smooth injection flow provided by this novel system will be well received by doctors and patients. Much of the clinical work was performed by Dr. Stacy Smith of Therapeutics, Inc. along with doctors from the United States, the United Kingdom and Germany. Dr. Smith observed, “Based on use in a controlled clinical setting, doctors noted improved precision in the placement of fillers, less fatigue and overall improved quality of correction when using the Smartfil™ system. Additionally, patients noted less pain and bruising with this system as compared to manual injections.”

Press release >> http://www.businesswire.com/portal/site/home/permalink/?ndmViewId=news_view&newsId=20090212005830&newsLang=en

Sensiotec Announces FDA 510(k) Class II Clearance for the World's First UWB Healthcare Unbound, Wireless, Non-Contact, Vital Signs Monitor

Device Monitors Heart and Respiration Rates, Bed Occupancy and Movement, Without Using Electrodes, Wires or Other Attachments that Cause Bruising, Skin Injury or Discomfort

ATLANTA, Feb. 11 (HSMN NewsFeed) -- Sensiotec Inc. announces FDA 510(k) Class II clearance for the world's first ultra-wideband (UWB) non-contact, continuous monitor for heart and respiration rates, bed occupancy and movement. Under the brand name Preventa(TM), Sensiotec will market and sell the medical device in the US and Canada under an exclusive worldwide license with its affiliate, Wireless 2000. Wireless 2000 received the sign off from the FDA's Division of Cardiovascular Devices.

Preventa(TM) is the first medical device to harness the potential of UWB, an emerging wireless communications standard and former classified military technology, creating a wireless vital signs monitor. In 2002, the FCC authorized the use of UWB for the development of new imaging systems to "see" inside the human body. Sensiotec CEO Robert Arkin states, "We're excited by the opportunity with Preventa(TM) to make a difference in people's lives through improved disease management while also addressing society's need to help contain runaway healthcare costs."

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Biomarker Combination and Risk of Ovarian Malignancy Algorithm (Roma(TM)) Demonstrates Accuracy in Detecting Ovarian Cancer

Data Presented at the Society of Gynecologic Oncologists' 40th Annual Meeting on Women's Cancer Proves Superiority of HE4, CA125 and ROMA(TM) Over Existing Tools

MALVERN, Pa., Feb. 11 (HSMN NewsFeed) -- New data presented on Saturday during the plenary session at the Society of Gynecologic Oncologists' 40th Annual Meeting on Women's Cancer demonstrated the accuracy of the HE4 test - in combination with CA125 blood test results and the Risk of Ovarian Malignancy Algorithm (ROMA(TM)) - in assessing the risk of ovarian cancer in women who will undergo surgery to remove a pelvic mass compared to the Risk of Malignancy Index (RMI). The data show that ROMA achieved greater sensitivity in distinguishing a benign mass from epithelial ovarian cancer (EOC) in premenopausal and postmenopausal women, and more accurately assigned patients with EOC to a high-risk group compared with RMI.

These results have important implications for the more than 280,000 American women who will be diagnosed with a pelvic mass over the course of a year. By combining the biomarkers HE4 and CA125 along with ROMA, the Fujirebio Diagnostics test appears to be more sensitive than the traditional RMI, which utilizes CA125 and imaging as well as menopausal status to evaluate the risk of ovarian cancer. CA125 is the current gold standard for monitoring patients diagnosed with ovarian cancer, but is less sensitive when used as a risk stratification tool, especially in premenopausal women, as elevated CA125 blood levels can result from non-cancerous conditions.

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Study Demonstrates Restylane(R) Effect Lasted 18 Months in 97% of Patients With One Repeat Injection

SCOTTSDALE, Ariz., Feb. 10 (HSMN NewsFeed) -- Recent clinical data show that Restylane(R) lasted 18 months in 97% of patients with one repeat injection. Restylane(R) is the only HA filler with an 18-month FDA-approved duration claim.

These data were generated in a controlled, randomized, evaluator-blinded study that assessed the safety and effectiveness of two different retreatment schedules, 4.5 months or 9 months, after initial treatment of nasolabial folds (NLF). Patients were evaluated using the Wrinkle Severity Rating Scale (WSRS), a five-point scale to measure visual severity of wrinkles where five is the most severe rating (extreme). 92% of patients were naive to dermal fillers so had no residual effects from earlier treatment.

Full article >> http://salesandmarketingnetwork.com/news_release.php?pipe=0000ac177000191&ID=2027206

Physicians Continue to Limit Sales Rep Access

More Than 38 Percent of Doctors Require Appointments, According to SK&A's Survey of U.S. Medical Practices

IRVINE, CA--(HSMN NewsFeed)--Feb 10, 2009 -- SK&A, a leading provider of healthcare information solutions and research, today announced the latest results of its ongoing survey of U.S. medical practices to determine their policies for allowing healthcare industry sales representatives access to physicians and other prescribers. In another setback to field sales groups, SK&A identified a clear trend that more physicians are requiring appointments from reps or limiting their access altogether.

Between June and December 2008, the percentage of physicians who require appointments advanced from 31.4 percent to 38.5 percent. Also, the percentage of physicians who forbid sales rep access altogether rose from 22.3 percent to 23.6 percent. These findings are based on telephone interviews with 227,000 medical practices representing 640,400 doctors. SK&A surveys its Office-Based Physicians database every six months from its Research Center in Irvine, Calif.

Full article >> http://salesandmarketingnetwork.com/news_release.php?pipe=0000ac177000191&ID=2027205

B. Braun Wins Premier Contract for Full Line of Dialysis Products

BETHLEHEM, Pa., Feb. 10 (HSMN NewsFeed) -- B. Braun Medical Inc. (B. Braun), a global leader in infusion therapy and pain management as well as a pioneer in passive safety devices and PVC-free and DEHP-free products, announced today that it has been awarded a three-year contract by Premier Purchasing Partners, LP for both hemodialysis and continuous renal replacement therapy (CRRT) dialysis products.

The contract, which became effective on November 1, 2008, offers Premier members - a network of approximately 2,100 hospitals and 53,000 healthcare facilities - access to contracted pricing on B. Braun's full line of dialysis products.

Full text >> http://salesandmarketingnetwork.com/news_release.php?pipe=0000ac177000191&ID=2027203

Guided Therapeutics, Inc. Reports Preliminary Findings from FDA Pivotal Clinical Trial

Non-invasive technology finds disease missed by Pap test

ATLANTA--(HSMN NewsFeed)--Guided Therapeutics, Inc. (GT) (Pink Sheets: GTHP ) today announced that its LightTouch™ non-invasive cervical cancer detection technology properly identified cervical disease missed by Pap tests and conventional pathology in a multi-site Food and Drug Administration (FDA) pivotal clinical trial. Based on the outcome of the study, GT plans to submit the trial results to the FDA as part of the Premarket Approval (PMA) application for the LightTouch.

“We are very pleased that the results of the study indicate that the LightTouch is capable of discovering disease that may be missed by conventional cervical disease detection,” said Mark L. Faupel, Ph.D., GT President and CEO at the Southeastern Medical Device Association annual conference in Atlanta. “Based on the study results, we believe that our technology also demonstrates the capability to detect cervical disease early, when it is most effectively treated.”

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FDA Approves Clinical Studies of a Novel Anti-Cancer Drug Developed by Italian Researchers

Nerviano Medical Sciences (NMS): Green Light From the FDA for the CDC7 Inhibitor

NERVIANO, Italy, February 10 (HSMN NewsFeed) -- Nerviano Medical Sciences (NMS) has secured Food and Drug Administration (FDA) approval to conduct for the first time clinical trials of a novel antitumoral agent. The drug blocks Cdc7, a protein that is responsible for the uncontrolled proliferation of cancer cells. The preclinical data, recently published on the prestigious journal Nature Chemical Biology ( http://www.nature.com/nchembio/journal/v4/n6/full/nchembio.90.html), demonstrate that inhibition of Cdc7 induces tumor cell death and blocks the growth of various types of cancer in experimental animal models.

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GORE Flow Reversal System Cleared by FDA

Breakthrough System Provides Neuroprotection During Carotid Artery Stenting by Reversing Blood Flow at the Treatment Site and Continuously Directing Emboli Away from the Brain

FLAGSTAFF, Ariz.--(HSMN NewsFeed)--W. L. Gore & Associates (Gore) today announced at the International Congress on Endovascular Interventions XXII the US Food and Drug Administration (FDA) has given the company 510(k) clearance to market the GORE Flow Reversal System. This new technology minimizes the risk of emboli reaching the brain during critical stages of carotid artery stenting (CAS), expanding treatment options for broad patient populations with carotid artery disease.

One of the major challenges associated with CAS is the risk of peri-procedural embolic events that could cause a stroke. The GORE Flow Reversal System is a unique neuroprotection technology that reverses the flow of blood at the treatment site prior to crossing the lesion. Flow reversal is achieved by selectively occluding common carotid and external carotid artery blood flow. By establishing an arterio-venous shunt, blood from collateral vessels via the Circle of Willis is redirected to the lower pressure venous return. Macro and micro emboli are continuously directed away from the brain during flow reversal.

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Gore Receives FDA Approval for Modification to GORE TAG Thoracic Endoprosthesis

With More Than 30,000 Devices Distributed Worldwide, the Premiere Choice for the Treatment of TAA is Now Available with an Improved Catheter Delivery System

FLAGSTAFF, Ariz.--(HSMN NewsFeed)--W. L. Gore & Associates (Gore) today announced at the annual International Congress of Endovascular Interventions XXII, that it has received approval from the US Food & Drug Administration (FDA) to market a modified version of the GORE TAG Thoracic Endoprosthesis for the treatment of thoracic aortic aneurysms (TAAs). The improved delivery catheter enhances the previous version of the GORE TAG Thoracic Endoprosthesis by adding a soft flexible tip to the leading end of the delivery system. The soft tip improves flexibility at the wire / catheter interface to facilitate tracking through challenging aortic anatomy. The hub component has also been modified to improve ease of use and durability.

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Johnson Medtechs non-magnetic motors power the worlds first MRI-guided prostate cancer treatment device

2009 FEB 10 - (NewsRx.com) -- Johnson Medtech, the medical products division of Johnson Electric, one of the world's largest providers of motion actuators, announced its participation in creating the world's first MRI-compatible image-guided tumor treatment device with Profound Medical Inc.(PMI). This revolutionary tissue coagulation device is expected to treat prostate cancer in a fraction of the time and cost of existing methods, based on extensive modeling, simulation and pre-clinical trials. Critical to the success of the system, Johnson Medtech's non-magnetic "Nanomotion" actuators enable the precision of motion and accuracy of treatment necessary for safely conducting the image-guided prostate cancer therapy within the strong magnetic field of the MRI (see also Prostate Cancer).

PMI's device uses an MRI for imaging and a proprietary planar ultrasound applicator for treatment. The MRI precisely guides the probe that heats the cancerous tissue to effectively destroy the diseased area. In the past, the magnetic nature of electric motors and their metal components made it impossible for motorized medical devices to function within the MRI environment. To overcome this challenge, PMI selected Nanomotion's HR2-1-N-3 piezo ultrasonic non-magnetic motors to rotate the device's probe. When combined with the real-time non-invasive visibility into the human body provided by the MRI, the sophisticated low-speed Nanomotion actuators in PMI's device enable medical professionals to operate the probe at a microscopic scale to conduct this groundbreaking procedure.

Full text >> http://www.johnsonelectric.com/What-s-New.69+M51afedd3108.0.html

Health Discovery Corporation Licenses New Prostate Cancer Test to Abbott

SAVANNAH, Ga.--(BUSINESS WIRE)--February 5, 2009--Health Discovery Corporation (OTCBB: HDVY) today announced that it has entered into an agreement with Abbott (NYSE: ABT) to commercialize HDC’s new molecular diagnostics gene-based tests for clinically significant prostate cancer. Abbott has acquired co-exclusive clinical laboratory rights and exclusive in vitro diagnostic rights for commercialization of HDC’s tissue-based prostate cancer test as well as HDC’s urine-based prostate cancer test.

Full article >> http://www.emailwire.com/release/19479-Health-Discovery-Corporation-Licenses-New-Prostate-Cancer-Test-to-Abbott.html

FluoroPharma Obtains US Patent for Imaging Cardiovascular Plaque using FDG

2009 FEB 13 - (NewsRx.com) -- FluoroPharma Inc., a company developing breakthrough molecular imaging agents for the Positron Emission Tomography (PET) market, announced that the United States Patent and Trademark Office issued U.S. Patent No. 7,438,891, covering methods of imaging cardiovascular plaque formation using F18 labeled 2-fluorodeoxy-D-glucose (FDG). This patent, exclusively licensed from the Massachusetts General Hospital, provides FluoroPharma with additional patent claims that cover imaging of atherosclerotic plaque inflammation and rupture (see also Patents).

"The use of 18F-FDG PET for imaging atherosclerosis, for tracking inflammation within plaque and for monitoring the response to drug therapy is promising and should be part of future diagnostic armament," said Dr. David Elmaleh, FluoroPharma founder and Chief Scientific Advisor.

"Molecular imaging of the inflammatory status of vulnerable atherosclerotic lesions is of paramount importance for the identification of patients at risk for a future heart attack or stroke," said Dr. Tom Brady, Director of Nuclear Medicine and Molecular Imaging Division at the MGH, "In vivo noninvasive clinical studies to measure carotid plaque inflammation show that 18F -FDG PET imaging can identify a subset of patients with carotid atherosclerosis that may benefit from intensified medical therapy or carotid artery intervention to prevent stroke."

Full text >> http://www.pharmalive.com/News/Index.cfm?articleid=599923

Noninvasive ExAblate® Treatment for Uterine Fibroids is Cost-Effective, New Study Says

2009 FEB 12 - (NewsRx.com) -- GE Healthcare and InSightec announced that new data show that the non-invasive ExAblate® 2000 Magnetic Resonance-guided Focused Ultrasound (MRgFUS) system is more cost-effective than myomectomy or Uterine Artery Embollization (UAE). The study appears in the January 2009 issue (Vol. 25, Issue 1) of The International Journal of Technology Assessment in Health Care (see also GE Healthcare).

“This study shows that treating uterine fibroids with MRgFUS is a cost-effective option for payers” said David Lee Ph.D., Senior Director, Health Economics and Outcomes Research, GE Healthcare. “With any healthcare treatment, there is the direct cost of the procedure, but there’s also the indirect cost of lost productivity, all the more crucial in today’s economy.”
Study results show that ExAblate patients enjoy a greater number of quality-adjusted life-years (QALYs) than those who undergo a myomectomy or a hysterectomy (17.36 vs. 17.31 and 17.18, respectively). ExAblate lifetime treatment costs were less than a myomectomy or uterine artery embolization, but more than hysterectomy, the most invasive of all procedures. “Taken together, the ratio of benefits to costs for ExAblate was well within accepted standards for cost-effectiveness,” said Dr. Lee.

Full article >> http://www.businesswire.com/portal/site/home/permalink/?ndmViewId=news_view&newsId=20090128005808&newsLang=en

Alma Lasers Announces FDA Clearance of the UniForm Handpiece

2009 FEB 13 - (NewsRx.com) -- Alma Lasers Ltd. ("Alma"), a leader in laser, light and radiofrequency-based aesthetic devices, announced the FDA clearance and immediate availability of the UniForm handpiece. The UniForm is the fifth module available on the Accent(TM) XL radiofrequency device. The UniForm has received FDA clearance for "the temporary reduction in the appearance of cellulite."

The UniForm handpiece is comprised of Alma's propriety UniPolar technology for the delivery of RF therapeutic heat into the dermal and subdermal tissue, accompanied by a mechanical massager component. The mechanical component increases circulation in the subcutaneous tissues producing superior results (see also Alma Lasers Ltd.).

Press release >> http://news.prnewswire.com/DisplayReleaseContent.aspx?ACCT=ind_focus.story&STORY=/www/story/01-26-2009/0004960430&EDATE=

Immunomedics' hPAM4 Labeled With Yttrium-90 Receives Fast Track Designation From FDA for Therapy of Pancreatic Cancer

MORRIS PLAINS, N.J., Feb. 5, 2009 -- (HSMN NewsFeed) -- Immunomedics, Inc. (NasdaqGM:IMMU ), a biopharmaceutical company focused on developing monoclonal antibodies to treat cancer and other serious diseases, today announced that it has received notice from the U.S. Food and Drug Administration (FDA) granting yttrium-90-labeled hPAM4 Fast Track designation for the treatment of pancreatic cancer.

The fast track programs, under the FDA Modernization Act of 1997, are designed to facilitate drug development and to expedite the review of new drugs that are intended to treat serious or life threatening conditions. Compounds selected must demonstrate the potential to address unmet medical needs. The fast track designation allows for close and frequent interaction with the agency. A designated fast track drug may also be considered for priority review with a shortened review time, rolling submission, and accelerated approval if applicable. The designation does not, however, guarantee approval or expedited approval of any application for the product.

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Breast Cancer Clinical Results Show Test Can Differentiate Normal, Early and Later Stage Cancers

TORONTO, Feb. 5 (HSMN NewsFeed) - Predictive medicine company PreMD Inc. (TSX: PMD; PREMF.pk) today announced that its recently completed clinical trial data was presented at the 4th Annual Academic Surgical Congress in Fort Myers, FL. The peer reviewed data was presented by Dr. Anees B. Chagpar from the University of Louisville. The presentation entitled, "Quantitative Galactose Oxidase Schiff's reaction in Nipple Aspirate Fluid may distinguish women with or without Breast Cancer" concluded by stating that "GOS reactivity as measured by adjusted chroma values are significantly different between normal patients, those with Ductal Carcenoma In Situ and those with invasive cancer" and that "these results warrant further investigation".

"We are extremely pleased that the data was supportive of this novel breast cancer test and that the investigators feel that there is a need to continue to explore the potential of this test, and thus confirm that there is value to the technology. However, it is clear that funding to develop these potentially valuable tests is not readily available today and as such, work on this test will cease, at least for a while," said Dr. Brent Norton, President and CEO of PreMD Inc. "We are hopeful that one or more interested parties' steps forward to invest in or acquire this technology as it has the potential to advance the fight against this disease," he added.

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Minocycline/Rifampin-Impregnated Catheters Proven Clinically Effective in Preventing and Combating Potentially Fatal Bloodstream Infections

Antimicrobial technology unique to Cook's Spectrum(R) catheters shown to be most effective in preventing infections that kill over 91,000 Americans a year

BLOOMINGTON, Ind.--(HSMN NewsFeed)--Minocycline/rifampin-impregnated catheters are a critical component in modern health care practices designed to eliminate potentially fatal catheter-related bloodstream infections (CRBSIs) that affect 250,000 Americans a year, according to recently released clinical data from the Society of Critical Care Medicine’s 38th Critical Care Congress. The first set of data reveal that an over-the-wire exchange of an infected central venous catheter (CVC) for a CVC impregnated with minocycline and rifampin, which are two antibiotic drugs that act together to dramatically reduce the risk of infections, can more quickly help eliminate an existing infection in cancer patients than currently recommended procedures. The second, a first ever head-to-head study that lasted 46 months, revealed that minocycline/rifampin-impregnated CVCs are nearly twice as effective at preventing CRBSIs than second generation CVCs coated with a chlorhexidine/silver sulfadiazine solution.

On February 2, 2009, Issam I. Raad, M.D., professor and chairman of infectious diseases at The University of Texas M. D. Anderson Cancer Center, presented data from a study of more than 100 cancer patients that had developed CRBSIs. The results demonstrated that exchanging an infected CVC for a CVC impregnated with minocycline and rifampin was significantly more effective at resolving the potentially fatal symptoms associated with CRBSIs, including acute fever and bacteremia, within 72 hours of insertion.

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Allium introduces first-ever Bladder-Neck Stent

Removable stent provides viable solution to patients recovering from complications of bladder and prostate cancer operations

CAESAREA, Israel – February 3, 2009 - (HSMN NewsFeed) - Allium Group, the developer and manufacturer of innovative stents for the urinary, gastro-intestinal, pulmonary and peripheral vascular tracts, announced today that it has been awarded a CE mark for its large caliber, removable posterior urethral stent. This is a novel solution for patients who developed a stenosis at the bladder neck after radical removal of the prostate or the bladder for cancer.

“As the fourth stent to receive a CE Mark, Allium’s technology is rapidly gaining an established presence throughout Europe as more hospitals and physicians discover the significant advantages of using removable stents as an effective solution,” said Limor Domnitz Gishri, CEO of Allium Medical. “Allium is at the forefront of the expanding stent industry, developing the only next generation stents designed to fit site specific areas in the urinary and gastro-intestinal tracts. Allium’s goal is to provide the global medical market with the tools to enhance patient treatment, comfort and quality of life with a minimally invasive approach."

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Globus Medical's SIGNATURE(TM) Spacer Designed for MILDER(TM) TLIF Procedures

AUDUBON, Pa., Feb. 3 (HSMN NewsFeed) -- Globus Medical, Inc., the largest privately held spinal implant manufacturer in the world, today announced the introduction of the PATRIOT SIGNATURE(TM) TLIF Spacer system designed for TLIF procedures. The SIGNATURE(TM) TLIF Spacer is the latest addition to Globus Medical's portfolio of MILDER(TM) Spine Care products.

The SIGNATURE(TM) TLIF Spacer system includes an articulating implant that enables surgeons to utilize a single instrument--from insertion through final placement--to deliver the spacer into the biomechanically ideal position through a portal or small incision. The ease of placement allows the surgeon to restore the natural lordotic alignment of the spine while employing an MIS approach. The system is designed to permit preservation of a significant portion of the musculature that lies between the skin and the surgical site on the spine while using a portal or mini-open technique.

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Smith & Nephew Announces Agreement with the OREF Regarding Grants to Support Research and Education in Orthopaedics

MEMPHIS, Tenn., Jan. 30 /PRNewswire-FirstCall/ -- Smith & Nephew, Inc. (NYSE: SNN, LSE: SN) announced today that its Orthopaedics Reconstruction Division has entered into a grant administration agreement with the Orthopaedic Research and Education Foundation (OREF).
Under the agreement, Smith & Nephew's first with a third-party administrator of grants, OREF will assist Smith & Nephew in continuing its long-standing support of research and education in orthopaedics. The multi-year agreement is unique among the major joint replacement makers in that it covers graduate medical education, including fellowships and residency enhancement programs, as well as continuing medical education (CME) and research. This comprehensive approach gives Smith & Nephew a platform from which to support consistent education and innovation in orthopaedics.

Press release >> http://biz.yahoo.com/prnews/090130/clf064.html?.v=84

Cook Medical Launches New Interventional Radiology Business Unit to Further Advance Fundamental and Critical Field of Medical Care

New division demonstrates Cooks unwavering commitment to interventional radiologists

BLOOMINGTON, Ind.--(HSMN NewsFeed)--Committed to broadening and reinvigorating the field of interventional radiology, Cook Medical today launches its Interventional Radiology Strategic Business Unit (SBU), which will support interventional radiologists who now perform many oncology, non-vascular and venous procedures in addition to angiographic procedures. The new SBU is dedicated to advancing the field of interventional radiology through significant investments in the development of new medical devices and technologies, which will empower and enable interventional radiologists to improve patient outcomes with skills and procedures best performed in interventional radiology labs.

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MedWaves, Inc. Receives MDD CE Certification and Additional U.S. FDA 510(k) Clearance to Market Its Patented Microwave Coagulation/Ablation

SAN DIEGO, Feb. 2 (HSMN NewsFeed) -- MedWaves, Inc. announces the receipt of Medical Device Directive (MDD) CE Mark Certification. This is in addition to having already received U.S. FDA 510(k) clearance to market the Company's patented Microwave Coagulation/Ablation System for surgical applications. The system and single patient use devices enable surgeons and interventional radiologists to treat soft tissue problems, such as tumors, using microwave thermal ablation. The clearance sets the stage for rapid expansion of the Company's product portfolio and indications for use through additional U.S. FDA clearances. The Company's proprietary technology focuses on the development of minimally invasive devices in wide ranges of size, shape and flexibility intended to meet clinicians' requirements for treatment of tumors in bone, liver, lung and other locations.

MedWaves Microwave Coagulation/Ablation System overcomes limitations of existing microwave and radiofrequency (RF) thermal ablation technologies, the standard of treatment for cancerous tumor patients who are not candidates for resection surgery. For these patients, microwave ablation can be adjunctive or a replacement for the curative and/or palliative therapies of standard therapies, such as chemotherapy and/or radiation. It can be an option for patients where other thermal modalities are not possible due to tumor size, location or patient condition.

Full text >> http://salesandmarketingnetwork.com/news_release.php?pipe=0000ac177000191&ID=2027120

Pathway Medical Technologies Receives FDA 510(K) Clearance for Jetstream G2 System

New Technology Delivers Highly Effective, Minimally Invasive Treatment for Entire Spectrum of Peripheral Artery Disease

KIRKLAND, Wash.--(HSMN NewsFeed)--Pathway Medical Technologies, Inc., an innovator of endovascular treatments for peripheral arterial disease (PAD), today announced that the U.S. Food & Drug Administration (FDA) has granted the company 510(k) clearance to market its newest peripheral atherectomy catheter for use in the treatment of PAD in the lower limbs. Jetstream G2™ is the latest technology innovation from Pathway and is capable of treating the entire spectrum of disease found in the PAD patient, including hard and soft plaque, calcium, thrombus and fibrotic lesions, with consistent results.

“Jetstream took conventional atherectomy procedures to the next level, enabling physicians to remove all types of both hard and soft tissue plaque with a single device and greatly improving the way patients are treated for peripheral artery disease,” said Pathway Medical Technologies President and CEO Paul Buckman, “Jetstream G2 is a major milestone for the company and the industry, and we firmly believe that this enhanced technology will significantly increase the number of PAD sufferers for whom atherectomy is a viable treatment option. Today’s news further underscores and validates Pathway’s continued commitment to delivering innovative technologies for the minimally invasive treatment of a condition that affects millions of people across the U.S.”

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Azzalure Receives Approval in Europe for Treatment of Glabellar Lines

PARIS & LAUSANNE, Switzerland--(HSMN NewsFeed)--Ipsen (Paris:IPN ), an international innovation-driven specialty pharmaceutical Group, and Galderma, the leading pharmaceutical company in dermatology, today announced that Azzalure®, a muscle relaxant specifically developed for aesthetic use, has received the collective green light from 15 European countries’ Health Authorities for the granting of national marketing authorizations. The assessment was based on clinical trials involving more than 2,600 patients, which confirmed the safety and efficacy of Azzalure®.

Stéphane Thiroloix, Ipsen’s Executive Vice-President in charge of Corporate Development said: “The collective green light from Health Authorities for Azzalure® confirms the quality of our botulinum toxin, backed by solid clinical data. In addition, this decision rewards the great work accomplished by the Ipsen and Galderma teams”. Stéphane Thiroloix added: “Once the local marketing authorizations are granted, we are convinced that Galderma’s expertise and sales force, combined with a product such as Azzalure® will efficiently bring a new treatment alternative and advancement for patients and the medical community”.

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