Mark in Medical Technology

StemCor Systems Receives CE Mark for MarrowMiner(TM) System for Bone Marrow Collection

Receipt of CE Mark Clears the Way for Commercialization in the European Union MENLO PARK, Calif., Sept. 10 /PRNewswire/ -- StemCor Systems, Inc., a medical device company developing systems for Enabling Regenerative Medicine(TM), announced today that the Company...

Nexgen Spine Receives CE Mark Approval for the Physio-L(R) Artificial Disc

WHIPPANY, N.J., Aug. 5 /PRNewswire/ -- Nexgen Spine, a leading developer of innovative spinal implants for the surgical treatment of degenerative disc disease, announced today that it has received CE mark approval to market the Physio-L(R) Lumbar Artificial Disc in the European Union. "We ar...

Cynosure Receives CE Mark for Smartlipo MPX(TM) Workstation

Company to Launch Innovative Laser Lipolysis Technology in the European Union WESTFORD, Mass., July 22 /PRNewswire-FirstCall/ -- Cynosure, Inc. (Nasdaq: CYNO ), a leading developer and manufacturer of a broad array of light-based aesthetic treatment systems, ha...

Medinol Receives CE Mark for Presillion(TM) Cobalt Chromium Coronary Stent on Rx System, an Advanced Evolution of the NIR(R) Family of Stents

Provides the Optimal Combination of Scaffolding, Deliverability and Conformability TEL AVIV, Israel, May 12 /PRNewswire/ -- Medinol is proud to announce that it has received CE Mark for its Presillion(TM) CoCr Coronary Stent, enabling physicians to treat coronary ...

Boston Scientific Announces CE Mark Approval for New Devices to Treat Heart Failure and Sudden Cardiac Death

NATICK, Mass., Jan. 22 /PRNewswire-FirstCall/ -- Boston Scientific Corporation (NYSE: BSX ) today announced CE Mark approval for its COGNIS(TM) cardiac resynchronization therapy defibrillator (CRT-D) and TELIGEN(TM) implantable cardioverter defibrillator (ICD). These devices represent entirel...

Life Recovery Systems Receives European CE Mark Approval for Its ThermoSuit(R) System

Medical Device Provides Rapid In-hospital Hypothermia Therapy ALEXANDRIA, La., Sept. 18 /PRNewswire/ -- Life Recovery Systems, HD, LLC, of Alexandria, LA and Kinnelon, NJ, an emerging provider of groundbreaking medical devices for the emergency medical care market, announced today that it...

CardioFocus Endoscopic Ablation System Earns CE Mark to Treat Atrial Fibrillation; US Clinical Investigation Underway

MARLBOROUGH, Mass., Aug. 1 /PRNewswire/ -- CardioFocus, Inc. announced today that it has been awarded CE Mark approval for its proprietary Endoscopic Ablation System. This novel transvenous device combines real-time, full color, endoscopic visualization and guidance with the delivery of therap...

Three New Drugs Mark New Era in Rheumatoid Arthritis Treatment

NEW YORK, June 13, 2007--Three new drugs for rheumatoid arthritis (RA) have ushered in a new era of treatment for this difficult and debilitating condition. The findings are reported in a New Drug Class study published early Online and in an upcoming edition of The Lancet. RA is the most common ...

John Legend and Gap Join (PRODUCT)RED(TM) to Help Eliminate AIDS in Africa with Exclusive (RED)ZONE Seating at Madison Square Garden

...private sector in raising awareness and funds for the Global Fund, to help eliminate AIDS in Africa. Companies whose products take on the (PRODUCT)RED mark contribute a significant percentage of the sales or portion of the profits from that product to the Global Fund to finance AIDS programs in Africa, wi...

British Woman Celebrates a Year of Living Cancer-Free

...hen, but I haven't been. I've been working five days a week from 9 to 5. I've been feeling fine," Ms. Scott said. Her good health and good mood mark a sharp change from how she felt when she was diagnosed with acute myeloid leukemia (AML) four years ago. AML is a cancer of the myeloid line of blood...

Terumo Cardiovascular Systems Initiates U.S. Clinical Trial for Anaconda(TM) AAA Stent Graft System

...ve years. The Anaconda system is commercially available outside the U.S. where it has been implanted in nearly 4000 patients. It received CE mark in Europe in April 2005. According to the Society of Vascular Surgery, physicians diagnose approximately 200,000 people with AAAs in the U.S....

World's First Cardiac Adult Stem Cell Patient Receives Infusion

...the heart through an artery in the patient's leg. The 66-year-old, self-employed man continues to recover following the outpatient procedure. mark Slaughter, M.D., Chief of the Division of Cardiothoracic Surgery at UofL and Director of the Heart Transplant and Mechanical Assist Device Program at ...

Elbit Imaging Ltd. Announces - Swiss Team Uses InSightec's ExAblate(R) 4000 Brain System to Treat Patients With Functional Brain Disorders

...ation in 2004 as a treatment for symptomatic uterine fibroids. 5,000 women have been treated worldwide to date. ExAblate 2000 received the European CE mark certification for pain palliation of bone metastases in June 2007. About InSightec InSightec Ltd. is a privately held company owned by E...

St. Francis Surgeon Uses Tissue Regeneration Technology to Rebuild Patients' Heart Structures

... market naturally occurring ECM(TM) products for cardiovascular applications. The company currently has U.S. clearance and European approval with a CE mark for its ECM Technology as an implant for pericardial closure, and clearance in the U.S. for use in cardiac tissue repair. For more information, visit ...

Neuroscience Researcher Has Positive Message for International Alzheimer's Awareness Week, July 6 - 12: 'Even Though World Economy is Declining, Alzheimer's Research is Advancing'

...hope: The answer for Alzheimer's disease and other degenerative diseases of the brain that cause memory loss may be much closer than we realize. mark Underwood, president of the Madison, Wisconsin-based biotech company, Quincy Bioscience ( www.quincybioscience.com ), says several recent studies ha...

Leading Experts Endorse Bioheart's Muscle Stem Cell MyoCell Therapy

...nd Regenerative Medicine, Columbia University Medical Center, discussed the anticipated MARVEL study, "this study, once completed, will be the bench mark and we are all very optimistic. Thomas Povsic, Assistant Professor of Medicine, Duke University Medical Center worked directly with the investigati...

Accumetrics, Inc. Announces GRAVITAS Trial 50 Percent Enrolled

... SAN DIEGO, June 30 /PRNewswire/ -- Accumetrics, Inc. announces that it has reached the halfway mark (1,600 patients) in the enrollment of its landmark clinical trial, GRAVITAS ( G auging R esponsiveness with A V erifyNow(R) Assay I mpact on T hro...

Mayo Clinic Proceedings Reviews Deep Brain Stimulation to Treat Psychiatric Diseases

..."Deep brain stimulation has long been seen as valuable for controlling movement disorders," according to the review, written by Susannah Tye, Ph.D., mark Frye, M.D. , from the Mayo Clinic Department of Psychiatry and Psychology , and Kendall Lee, M.D., Ph.D. , Mayo Clinic Department of Neurosur...

Vantia Therapeutics' Lead Candidate VA106483 Demonstrates Positive Anti-diuretic Effect in Phase IIa Trial in Nocturia

...ntia Therapeutics Dr Jim Phillips, CEO, +44(0)238-076-3433 info@vantia.com , +44(0)7515-397176 Citigate Dewe Rogerson Chris Gardner, mark Swallow, Helena Galilee, +44(0)207-638-9571 vantia@citigatedr.co.uk ...

Innovative Psoriasis Treatment PSORENT(R) Announces Healthcare Cost Savings Potential Consistent with President Obama's Announcement on Healthcare Reform

...PRNewswire/ -- "Congratulations President Obama on your agreement with large pharmaceutical companies to cut prescription costs for the elderly," says mark D. Steele, president of NeoStrata Company, Inc. "We thought you should know that you have a little company in New Jersey that's done the same for psor...

CoAxia, Inc. Announces $21.5M Series D Financing

...y the US FDA via Humanitarian Device Exemption for the treatment of cerebral vasospasm, have received US FDA 510(k) clearance, and have secured the CE mark for cerebral perfusion augmentation. Sofinnova Partners is an independent venture capital firm based in Paris, France that specializes in investm...

Alfacell Provides Shareholder Update

...have this opportunity to share with you important developments taking place at this critical juncture in our company history. This communication shall mark what I hope will be the first of many as your president. Like many of you, I also have been a longtime shareholder and supporter of this company...

Arena Pharmaceuticals Announces Lorcaserin Data Demonstrating Highly Significant Categorical and Absolute Weight Loss and Improvements in Secondary Endpoints Associated with Cardiovascular Risk

...ns for improving co-morbidities associated with excess weight and further demonstrates the medically significant benefits of 5% or more weight loss, a mark two-thirds of the lorcaserin patients who completed the BLOOM trial achieved." "Given the positive lorcaserin BLOOM results, we are focused on pa...

Cardiogenesis Announces Presentation of its PHOENIX(R) Combination TMR Plus Stem Cell Delivery System at the International Society of Minimally Invasive Cardiothoracic Surgeons (ISMICS) Annual Meeting

...howed improved perfusion in the regions of myocardium treated by the PHOENIX System The PHOENIX combination delivery system is CE mark approved and has been used in over 50 procedures at cardiac centers outside the U.S. It is not currently FDA approved. The abstract " One Year Follow...

Definitive Outcomes of Radiofrequency Ablation for Barrett's Esophagus Using the HALO Ablation System Reported at the Digestive Disease Week Meeting for Gastroenterologists and Esophageal Surgeons

...tients were Barrett's-free after two and a half years of follow-up. Both HALO systems are cleared by the FDA for use in the U.S. and both have CE mark for use in Europe. More than 30,000 procedures have been performed in over 280 hospitals around the world. Based in Sunnyvale, Calif., BARRX Medical...

Researchers Present Safety and Efficacy Results of 429 Patients Treated With Radiofrequency Ablation for Pre-Cancerous Barrett's Esophagus

...tients were Barrett's-free after two and a half years of follow-up. Both HALO systems are cleared by the FDA for use in the U.S. and both have CE mark for use in Europe. More than 30,000 procedures have been performed in over 280 hospitals around the world. Based in Sunnyvale, Calif., BARRX Medical...

TNFerade(TM) Phase III Data Presented at ASCO

... plus standard-of-care (SOC) arm compared to the patients receiving SOC alone (Hazard Ratio = 0.75; 95% Confidence Interval [0.494 - 1.15]). Dr. mark Thornton, GenVec's Senior Vice President of Product Development commented on the poster, noting, "In the SOC patients, 75% of the patients died within...

Study in the New England Journal of Medicine Shows Non-Surgical Treatment for Pre-Cancerous Condition of Esophagus is Effective and Reduces Risk for Cancer Development

... and used to treat smaller, non-circumferential areas of disease. Both HALO systems are cleared by the FDA for use in the U.S. and both have CE mark for use in Europe. More than 30,000 procedures have been performed in over 280 hospitals around the world. Based in Sunnyvale, Calif., BARRX Medical...

PAREXEL Reaches Milestone in Management of Oncology Trials Over Last Five Years Involving 175,000 Patients Worldwide

... scale to help biopharmaceutical companies access diverse patient populations, navigate regulatory issues, and identify effective investigators," said mark A. Goldberg, M.D., Chief Operating Officer, PAREXEL International. "With approximately 10 million people diagnosed with cancer each year worldwid...

Boston Scientific Welcomes Results of Brain Aneurysm Clinical Trial

...aordinary work by Drs. Molyneux and Kerr and the ISAT investigators represents a milestone in the evolution of treatment for cerebral aneurysms," said mark Paul, President, Boston Scientific Neurovascular. "The data from ISAT over the last six years have informed the worldwide neurovascular community and...

Getting More From Whole-Transcript Microarrays

...ve splicing and to meet the demand to analyse this on a genome-wide scale, Affymetrix have developed their Exon 1.0 ST platform. However, the study by mark Robinson and Terence Speed from the University of Melbourne and the Walter and Eliza Hall Institute of Medical Research in Australia suggests that t...

Terumo Heart, Inc. Reaches Clinical Milestone as the 100th Patient Worldwide Receives the DuraHeart(TM) Left Ventricular Assist System

...ing to sustain patients awaiting heart transplant who are at risk of death due to end-stage left ventricular failure. The DuraHeart LVAS carries a CE mark and is currently available for sale in European countries. Additionally, the company has completed clinical trial enrollment for this device in Japan...

Boston Scientific Launches Third-Generation Platinum Chromium Drug-Eluting Stent

...ients with complex coronary artery disease. The Company is anticipating CE mark approval for both the TAXUS Element Stent and the PROMUS Element Stent Syst...(R) Element(TM) and PROMUS(R) Element(TM) Drug-Eluting Stent Systems are CE mark pending; Element(TM) Bare-Metal Stent is under development. Not available f...

Pivotal Data Show Bronchial Thermoplasty Can Improve Quality of Life and Reduce Asthma Attacks and Emergency Room Visits for Adults with Severe Asthma

...oplasty was named one of the "Top Ten Medical Innovations for 2007" by the prestigious Cleveland Clinic Foundation. The Alair System has received a CE mark for use in the European Union. For more information on Asthmatx visit www.asthmatx.com . ...

Pelleve Receives FDA Clearance for the Treatment of Mild to Moderate Facial Wrinkles

...y, Plastic and Reconstructive Surgery at the University of Rome in Rome, Italy. Ellman's skin tightening technology has been marketed with a CE mark in many countries since 2005 under the name Radiage. "We have seen positive results in many patients outside of the United States. Because this unique...

Unique Cardiovascular Treatment Readied for Global Market: Proprietary Paccocath(R) Technology is the Only Drug Eluting Balloon with Clinical Data

...utilizes the Paccocath technology. MEDRAD is in the process of obtaining CE mark certification and seeking FDA approval for its Cotavance product. William G...) Thrombectomy Systems, MEDRAD Avanta(R) Fluid Management Injector Systems, mark V ProVis(R) Angiographic Contrast Injectors, the GuardDOG (R) Occlusion Sys...

Oxford BioTherapeutics and GlaxoSmithKline Form Strategic Alliance to Develop Novel Cancer Therapeutic Antibodies

...proteins combined with their genomic and clinical information derived from human blood and cancer tissue studies. OGAP(R) is a registered trade mark of Oxford BioTherapeutics Ltd. For further information, please see http://www.OxfordBioTherapeutics.com or http://www.oxbt.co.uk Oxf...

Juvenile Diabetes Research Foundation to Honor Duane DeSisto of Insulet Corporation and Senator Edward M. Kennedy at 27th Annual Hearts & Heroes Gala

...d hors d'oeuvres reception, seated dinner, live and silent auctions, and dancing to the sounds of The Marsels. FOX25 News Anchors Maria Stephanos and mark Ockerbloom will serve as event emcees. About JDRF JDRF is the leader in setting the agenda for diabetes research worldwide, and is the larg...

PLC Medical Systems to Demonstrate RenalGuard(R) at EuroPCR 2009

...isseminating new information on how to prevent it are very important." mark R. Tauscher, president and chief executive officer of PLC Systems, said, "W...dration therapy will be provided using RenalGuard. PLC received the CE mark Certificate for the RenalGuard System in December 2007, and concluded its p...

Metabolic Solutions Development Company Announces Preliminary Results from Phase IIa Clinical Trial

...gredient in Actos, during his tenure with Upjohn Company. "We are pleased that our lead compound performed so well in the Phase IIa study," said mark Olesnavage, chief executive officer of MSDC. "The preliminary Phase IIa results match our pre-clinical studies that suggested that this compound can ...