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Clearance in Medical Technology

Project Zero Delay Accelerates Drug's Path to Clinical Trial

... two days after U.S. Food and Drug Administration clearance of the experimental drug for a first-in-human ... In addition, tasks usually done after FDA clearance of an Investigational New Drug (IND) application ... protocol to first patient in 46 days, with FDA clearance of the IND on day 44. Research elsewhere cited ...

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

... Food and Drug Administration (FDA) has granted clearance to Pelleve(TM), a skin tightening system for the ... and rhytids for skin phototypes I-IV. The clearance was granted based on clinical data demonstrating ... on the face through six months. "Today's FDA clearance of the Pelleve system represents a very exciting ...

Studies Show Combination Laser Therapy Effective At Clearing Acne, Reducing Oil Production

... 5-aminolevulinic acid provides long-lasting clearance of acne lesions. "Laser technology has made ... the ALA PDT treatment group experienced complete clearance of their acne. She reported that an average of ... alone or conventional therapy achieved complete clearance of their acne. "The first-of-a-kind study ...

PEAK Surgical Receives 510(k) Clearance to Market PEAK(R) Surgery System for Use in Expanded Indications

... (FDA) has granted the company 510(k) clearance to market its PEAK(R) Surgery System for cutting ... The PEAK Surgery System, which received FDA clearance for use in general surgery in July 2008, includes ... in the first half of 2009. "With the FDA clearance of expanded surgical indications and ...

Cardica Reports Positive Top-Line Results and Submits 510(k) for PAS-Port(R) Proximal Anastomosis System in Cardiac Bypass Surgery

... C-Port system, and subject to receiving clearance of the PAS-Port system from the FDA, we will be ... has submitted a 510(k) premarket notification for clearance to market the PAS-Port system in the United ... with whether and when Cardica receives FDA clearance for the PAS-Port system, and the lack of ...

Cardium's Innercool Therapies Unit Announces Publication of Positive Effects of Early and Rapid Hypothermia Following Heart Attack

... Control System(TM) has received FDA 510(k) clearance for use in inducing, maintaining and reversing ... modulation is expected to receive FDA clearance in the second quarter 2008, and to initially have the same clearance as the Celsius Control System. The RapidBlue ...

Two Point of Care Tests From Quest Diagnostics Receive FDA 510(k) Clearance

... Diagnostics subsidiaries have received FDA 510(k) clearance for two new point of care tests. The HemoCue(R) ... laboratories. The company also received FDA clearance for Focus Diagnostics' HerpeSelect(R) Express(TM) ... numerous conditions and disorders. With 510(k) clearance for marketing, physicians who operate ...

Lilly Files for European Approval of ALIMTA(R) (pemetrexed for injection) for First-Line Treatment of Non-Small Cell Lung Cancer

... age. Renal impairment: Patients with creatinine clearance > or = 45 ml/min require no dose adjustment other ... for all patients. Use in patients with creatinine clearance below 45 ml/min is not recommended. See also ... secreted could potentially result in delayed clearance of pemetrexed. If necessary, ...

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

... 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 ...

Osteotech Completes Enrollment for DuraTech(TM) BioRegeneration Matrix Clinical Trial

... stemming from this trial to support its 510(k) filing for marketing clearance with the United States Food and Drug Administration later this year. ... our 510(k) for DuraTech during the third quarter of 2009 and anticipate clearance of the product before the end of the year," said Sam Owusu-Akyaw, ...

Medarex Announces Allowance of Investigational New Drug Application for Wholly-Owned Fully Human Anti-CXCR4 Antibody, MDX-1338

... will succeed or that developed products will receive required regulatory clearance or that, even if such regulatory clearance were received, such products would ultimately achieve commercial success. ...

Medarex Announces Primary Endpoint Achieved in MDX-1100 Anti-IP-10 Antibody Phase 2 Trial for Rheumatoid Arthritis

... will succeed or that developed products will receive required regulatory clearance or that, even if such regulatory clearance were received, such products would ultimately achieve commercial success. ...

Pharmaxis Announces Positive Results of Phase 3 Cystic Fibrosis Trial

... to be effective and well tolerated in stimulating mucus hydration and clearance in people with chronic obstructive lung diseases. In particular, Bronchitol has been shown to increase mucus clearance from the lungs and significantly improve quality of life for people with ...

Medarex Announces Preclinical Data from Multiple Research Programs Demonstrating Anti-Tumor Activity in Cancer

... succeed or that other developed products will receive required regulatory clearance or that, even if such regulatory clearance were received, such products would ultimately achieve commercial success. ...

Cardium's InnerCool Announces Positive Benefits of Cooling During Robotic-Assisted Prostate Surgery Published in Urology

... technique for prostate cancer. A regulatory application for FDA 510(k) clearance of InnerCool's UroCool(TM) catheter is expected to be submitted in the ... system. We plan to submit a regulatory application for FDA 510(k) clearance for the new UroCool(TM) catheter this month," stated Christopher J. ...

Aerovance Initiates Phase IIb Clinical Trial with Aerovant(TM) for the Treatment of Uncontrolled Asthma

... 2 /PRNewswire/ -- Aerovance Inc. today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) and the U.K. Medicines ... fractional concentration of expired nitric oxide (FeNO). "Regulatory clearance and initiation of AeroTrial are significant milestones for Aerovance and ...

Update of Long-Term Data on Brain Cancer Patients Receiving DCVax(R)-Brain Continues to Show Striking Improvements in Delay of Disease and Survival

... patients at 11 sites across the U.S. The Company has also received clearance from the FDA for a large Phase III trial in prostate cancer, and clearance from the FDA for Phase I trials in five other cancers. The Company has ...

Synvista Therapeutics Announces Published Data Demonstrating Elevation of Carboxymethyl-Lysine (CML) Is Associated with Decline in Renal Function and Arterial Stiffness in Older Adults

... clinical diagnostic assay as it prepares to submit a CML kit for 510(k) clearance in the second half of 2009. "These studies represent an important ... Synvista Therapeutics. "We believe that a clinical diagnostic test, upon clearance by the FDA, to measure CML levels may one day provide these patients and ...

Medarex Announces Initiation of Phase 1b Clinical Development Program with MDX-1106 for the Treatment of Cancer

... will succeed or that developed products will receive required regulatory clearance or that, even if such regulatory clearance were received, such products would ultimately achieve commercial success. ...

Long-Term Phase I and Phase I/II Trial Data Continue to Show Striking Improvement in Survival of Brain Cancer Patients Who Receive DCVax(R)-Brain

... and powered to serve as a pivotal trial. The Company has also received clearance from the FDA for a large Phase III trial in prostate cancer, and clearance from the FDA for Phase I trials in five other cancers. The Company has ...

Medarex Receives Milestone Payment from Pfizer for Investigational New Drug Application Filing

... succeed or that other developed products will receive required regulatory clearance or that, even if such regulatory clearance were received, such products would ultimately achieve commercial success. ...

Medarex Announces Initiation of Phase 2 Clinical Development Program for the Treatment of Lupus

... succeed or that other developed products will receive required regulatory clearance or that, even if such regulatory clearance were received, such products would ultimately achieve commercial success. ...

Medarex Highlights Strength in Antibody Development and Underlying Pipeline Strategy at R&D Day Event in New York City

... will succeed or that developed products will receive required regulatory clearance or that, even if such regulatory clearance were received, such products would ultimately achieve commercial success. ...

Positive Mid-Term Results on CryoValve(R) SG Pulmonary Human Heart Valve Presented at Western Thoracic Meeting

... valve received market clearance from the FDA in February 2008. The market clearance was supported by documenting the substantial equivalence of the CryoValve ... throughout the United States and Canada. The Company recently received FDA clearance for the CryoValve(R) SG pulmonary human heart valve, processed using ...

Vermillion Files 510(k) Application With U.S. Food & Drug Administration for OVA1 Ovarian Tumor Triage Test

... to the U.S. Food & Drug Administration (FDA) requesting regulatory clearance of its Ovarian Tumor Triage Test known as OVA1(TM). As announced ... and CEO of Vermillion. "We also look forward to receiving regulatory clearance from the FDA and making OVA1 available to the hundreds of thousands of ...

Intellect Neurosciences, Inc. and Medical Research Council Technology (U.K.) Reach Important Milestone in Generating an Alzheimer's Therapeutic Antibody

... of Alzheimer's disease. The antibody is intended to be used to promote clearance from the brain of beta amyloid, the toxin that leads to Alzheimer's ... available to bind to the endogenous beta-amyloid toxin, thus promoting its clearance away from the brain. This therapeutic outcome can be achieved either by ...

Interim Phase 1/2 Data of Ipilimumab in Prostate Cancer Presented at American Society of Clinical Oncology Annual Meeting

... will succeed or that developed products will receive required regulatory clearance or that, even if such regulatory clearance were received, such products would ultimately achieve commercial success. ...

Schering-Plough Highlights PEGINTRON(TM) and Boceprevir Hepatitis C Data Presentations at Digestive Disease Week (DDW) Annual Meeting

... No. 442673, Sunday, May 18, 8:00 a.m. - 5:00 p.m., Sails Pavilion. clearance of HCV at 5 Year Follow-Up for Peginterferon Alfa-2b with or without ... thalassemia major, sickle-cell anemia), and patients with creatinine clearance less than 50 mL/min. Avoid Pregnancy REBETOL therapy should not be ...

Intercell AG to Acquire Iomai Corporation to Expand Late Stage Product Pipeline and Strengthen Leadership in Vaccine Innovation

... is subject to customary closing conditions including antitrust clearances, clearance by the Committee on Foreign Investment in the United States and the ... to be held as soon as practical, receipt of antitrust clearances and clearance by the Committee on Foreign Investment in the United States. Intercell and ...

Medarex Announces Initiation of Phase 2 Clinical Trials for the Treatment of Ulcerative Colitis and Rheumatoid Arthritis

... or whether other developed products will receive required regulatory clearance or that, even if such regulatory clearance were received, such products would ultimately achieve commercial success. ...

Schering-Plough Highlights PEGINTRON(TM) and Boceprevir Data Presentations at European Association for the Study of the Liver (EASL) Annual Meeting

... after peginterferon alfa-2b and ribavirin treatment predicts long-term clearance of HCV at 5-year follow-up. Manns, M. et al. Platelet count predicts ... thalassemia major, sickle-cell anemia), and patients with creatinine clearance less than 50 mL/min. Avoid Pregnancy REBETOL therapy should not be ...

Medarex Reports Interim Data from Ongoing Ipilimumab Combination Phase 1 Studies in Prostate Cancer at American Association for Cancer Research Meeting

... or whether other developed products will receive required regulatory clearance or that, even if such regulatory clearance were received, such products would ultimately achieve commercial success. ...

Synvista Therapeutics Presents New Preclinical Data Demonstrating the Value of Haptoglobin Genotype Testing In Diabetes at ACC Scientific Sessions

... mice with the Haptoglobin 2-2 genotype that show impairment in the clearance of the Haptoglobin (Hp)-Hemoglobin (Hb) complex may result in a ... patients (Hp2-2) with vitamin E." In the study, researchers assessed clearance of Hb by Hp in diabetic mice that were also tested for Hp type. The study ...

Phase I and Phase I/II DCVax(R)-Brain Data Continues to Show Significantly Improved Survival Rates for Brain Cancer Patients

... and powered to serve as a pivotal trial. The Company has also received clearance from the FDA for a large Phase III trial in prostate cancer, and clearance from the FDA for Phase I trials in five other cancers. The Company has ...

InterCure Announces 100,000th RESPeRATE Unit Sold

... advocacy and consumer awareness began to take hold following the OTC clearance of the device. The second 50,000 units were sold in just 15 months. Growth ... in most key international markets (including FDA over-the-counter ("OTC") clearance in the U.S., the European CE mark and the Chinese SDA among others) and a ...

Abbott's HUMIRA(R) (adalimumab) Receives FDA Approval For Moderate to Severe Chronic Plaque Psoriasis

... Fifth Disease Indication for HUMIRA Provides Patients with Visible clearance of Inflamed Skin Lesions Caused by Chronic Autoimmune Disease ABBOTT ... and CHAMPION, showing that nearly 3 in 4 patients achieved 75 percent clearance or better at week 16 of treatment versus placebo. HUMIRA has 10 years of ...

Northwest Biotherapeutics Conducting Ovarian Cancer Clinical Trial With DCVax(R)-L at University of Pennsylvania

... and powered to serve as a pivotal trial. The Company has also received clearance from the FDA for a large Phase III trial in prostate cancer, and clearance from the FDA for Phase I trials in five other cancers. The Company also ...

Medarex Announces Allowance of Investigational New Drug Applications for Wholly Owned Fully Human Anti-CD19 Antibody, MDX-1342

... succeed or that other developed products will receive required regulatory clearance or that, even if such regulatory clearance were received, such products would ultimately achieve commercial success. ...

FDA Clears Advanced Test for Monitoring Metastatic Colorectal Cancer

... that the U.S. Food and Drug Administration (FDA) has granted an expanded clearance for the CellSearch(TM) System to be used as an aid in the monitoring of ... multi-center clinical trial was conducted to validate the expanded clearance for CellSearch. The study, which took place in 55 clinical centers in the ...

Palatin Technologies, Inc. Reports Initiation of Human Trials for the Treatment of Congestive Heart Failure

... is believed to relate to diminished affinity for the natriuretic peptide clearance receptor and increased resistance to the enzyme neutral endopeptidase, both pathways for clearance of endogenous natriuretic peptides. In animal models, PL-3994 was able to ...
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(Date:9/18/2014)... research into the Crimean-Congo hemorrhagic fever virus (CCHFV), a ... humans similar to that caused by Ebolavirus, has identified ... has the potential to lead to novel targets for ... research, reported in a paper published today in the ... at the Texas Biomedical Research Institute and their colleagues, ...
(Date:9/18/2014)... prompts millions of Americans to undertake jaunts into the countryside ... little longer within a century, according to new research. , ... of the United States as summer temperatures linger later into ... Global Ecology and Biogeography . For instance, the paper birch ... of New Hampshire could change color one to three ...
(Date:9/18/2014)... Americans across racial and ethnic groups describe losing ... their day-to-day life, more so than other conditions ... (57% of African-Americans, 49% of non-Hispanic whites, 43% ... which disease or ailment is the worst that ... African-Americans followed by AIDS/HIV. Hispanics and Asians ...
Breaking Biology News(10 mins):Research milestone in CCHF virus could help identify new treatments 2Fall foliage season may be later, but longer on warmer Earth 2Fall foliage season may be later, but longer on warmer Earth 3Fall foliage season may be later, but longer on warmer Earth 4Americans rate losing eyesight as having greatest impact on their lives 2Americans rate losing eyesight as having greatest impact on their lives 3
(Date:9/18/2014)... Sept. 18, 2014 (HealthDay News) -- Rising temperatures in ... to spread to shallow waters that are becoming warmer, ... coral reefs, ecologists report. A study of 40 ... shows northward movement by the invasive and poisonous lionfish, ... Administration (NOAA) and the University of North Carolina-Wilmington, who ...
(Date:9/18/2014)... HealthDay Reporter , THURSDAY, Sept. 18, ... in West Africa is starting to spread faster than ever, the ... of the deadly viral infection were reported in just one week. ... 5,300, with roughly half of those reported in the past three ... now tops 2,600. WHO has estimated that as many as ...
(Date:9/18/2014)... 18, 2014 Limited spots remain at ... Only 100 spots are still available for Becker's ASC ... ASCs on October 23-25, 2014 at the Swissotel Chicago. ... Chief Information Officer Strategy Roundtable on November 4, 2014 ... remain for Becker's Hospital Review Chief Executive Officer Strategy ...
(Date:9/18/2014)... One of the most capable and ... ShandsCair Flight Program’s new EC155 B1, will ... at the Air Medical Transport Conference (AMTC), Sept. 22-24, ... into service ShandsCair EC155 and the Vanderbilt University ... AMTC highlight Airbus Helicopters broad, industry leading line-up of ...
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Breaking Medicine News(10 mins):Health News:Rising Atlantic Ocean Temperatures Could Pose Threat to Reefs 2Health News:New Ebola Cases Top 700 in Just One Week, Officials Report 2Health News:New Ebola Cases Top 700 in Just One Week, Officials Report 3Health News:Limited Spots Remain at Becker's Upcoming ASC and Hospital Conferences 2Health News:Airbus Helicopters Inc. Features Industry-leading Models at AMTC 2Health News:Airbus Helicopters Inc. Features Industry-leading Models at AMTC 3Health News:Airbus Helicopters Inc. Features Industry-leading Models at AMTC 4Health News:Evensong Spa Celebrates Spa Week with $50 Services 2Health News:Evensong Spa Celebrates Spa Week with $50 Services 3
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