Navigation Links
Clearance in Medical News

Chesson Labs Liquid Bandage Product NUVADERM(TM) Receives FDA 510(k) Market Clearance

... Labs today announced receiving 510(k) market clearance from the U.S. Food and Drug Administration (FDA) ... the Company's liquid bandage product. The 510(k) clearance allows Chesson Labs to market and sell the ... has antimicrobial properties. NUVADERM's clearance is a significant milestone for Chesson Labs ...

Palomar Medical Reports Financial Results for Second Quarter 2009

... to receive a 510(k) over-the-counter (OTC) clearance from the United States Food and Drug ... home-use, light-based hair removal device. OTC clearance allows the product to be marketed and sold ... respect to medical devices, including whether FDA clearance will be obtained for future products and ...

New ACTICOAT(TM) Silver Coated Anti-microbial Barrier Dressing Receives 510(k) Clearance from the US FDA

... Drug Administration (FDA) granted marketing clearance for Acticoat(TM) Flex. Acticoat(TM) Flex is an ... are pleased that the US FDA has granted marketing clearance for Acticoat(TM) Flex," said David B. Holtz, ... elbow joints. "We are delighted with the US FDA clearance for Acticoat(TM) Flex. We have had excellent ...

Palomar Medical Technologies To Host Second Quarter 2009 Financial Results Conference Call and Webcast on July 30, 2009

... to receive a 510(k) over-the-counter (OTC) clearance from the United States Food and Drug ... became the first company to receive a 510(k) OTC clearance from the FDA for a new, patented home use, laser ... for the treatment of periorbital wrinkles. OTC clearance allows products to be marketed and sold directly ...

Varian Medical Systems Receives 510(k) Clearance for Fast and Accurate Acuros(TM) Radiotherapy Treatment Planning Capability

... ) today announced that it has received FDA 510(k) clearance for the Acuros(TM) capability offered initially ... treatment planning system. The Acuros clearance was awarded as part of the market-leading ... Monte Carlo method." "Securing 510(k) clearance is an important milestone in making this exciting ...

Pulmonx Announces New President and CEO Michael A. Baker to Lead Interventional Pulmonology Company

... including the receipt of FDA marketing clearance for a key new product and the completion of a ... In early July, the company received FDA marketing clearance for the Chartis System, an assessment tool which ... endobronchial valve therapy. The FDA clearance follows Pulmonx's recent acquisition of Emphasys ...

CareFusion to Resume Shipping Alaris(R) Infusion Products

... is ready to resume shipments following 510(k) clearance from the Food and Drug Administration (FDA) for a ... on new Alaris PC units. "The 510(k) clearance for our software correction is another important ... the safest in the industry." The 510(k) clearance follows FDA acceptance of the company's ...

Video: Get Swimsuit Ready Faster and Easier Than Ever Before With New LifeSculpt Laser Treatment

... to receive a 510(k) over-the-counter (OTC) clearance from the United States Food and Drug ... home use, light-based hair removal device. OTC clearance allows the product to be marketed and sold ... respect to medical devices, including whether FDA clearance will be obtained for future products and ...

Palomar Successful in U.S. Patent Office Re-Examination of Hair Removal Patent

... Palomar was the first company to receive FDA clearance and bring a high powered light-based hair removal ... was later the first company to receive FDA clearance for permanent hair reduction and the first company to receive over-the-counter clearance from the FDA for a hair removal device. After ...

Instrumentation Laboratory Receives 510(k) Clearance From FDA for HemosIL(R) Liquid Heparin Assay

... (IL) today announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) ... well as a European CE IVD Mark. With this latest clearance in the US, the company can now initiate ... "We are very pleased with the rapid clearance of HemosIL Liquid Heparin by the FDA. This ...

A Milestone of Opportunity for VNUS Medical Technologies

... procedure performed March 1999: FDA clearance of the VNUS Closure catheter and radiofrequency ... of the procedure October 2005: FDA clearance of the Closure RFS device for treatment of perforator veins August 2006: FDA clearance of ClosureFAST, the next-generation catheter ...

Palomar Receives FDA Over-The-Counter Clearance for a Home Use Wrinkle Removal Laser Device

... clearance Opens Door To Multi-Billion Dollar Home Skin Care ... to receive a 510(k) over-the-counter (OTC) clearance from the United States Food and Drug ... for the treatment of periorbital wrinkles. OTC clearance allows the device to be marketed and sold ...

FDA Approves SAMSCA(TM) (tolvaptan), the First and Only Oral Vasopressin Antagonist to Treat Patients With Clinically Significant Hypervolemic and Euvolemic Hyponatremia

... Sodium Levels Through Increase in Free Water clearance TOKYO and PRINCETON, N.J., May 21 ... SAMSCA are similar in patients with a creatinine clearance of 10-79 mL/min and in patients without renal ... not been evaluated in patients with creatinine clearance less than 10 mL/min or in patients undergoing ...

New Clinical Data Shows Significant Improvement in the Appearance of Fat Using SlimLipo(TM) Laser

... to receive a 510(k) over-the-counter (OTC) clearance from the United States Food and Drug ... home use, light-based hair removal device. OTC clearance allows the product to be marketed and sold ... respect to medical devices, including whether FDA clearance will be obtained for future products and ...

NovaBay Pharmaceuticals, Inc. Reports First Quarter 2009 Financial Results

... support and a milestone payment triggered by the clearance of an Investigational New Drug (IND) application ... lead Aganocide compound, after receiving clearance of an IND application from the FDA in January. The IND clearance triggered a milestone payment of $1 million from ...

Sodium channel blocker shows promise as a potential treatment for cystic fibrosis

... system," Dr. Hirsh said. "Diminished mucous clearance leads to chronic respiratory infection and ... studies revealed that the agent enhanced mucous clearance for more than four hours. The results offer new ... increase airway surface liquid and enhance mucous clearance in an animal model," he said. "The results ...

Palomar Wins Two European Hair Removal Patent Opposition Hearings

... to receive a 510(k) over-the-counter (OTC) clearance from the United States Food and Drug ... home use, light-based hair removal device. OTC clearance allows the product to be marketed and sold ... respect to medical devices, including whether FDA clearance will be obtained for future products and ...

Palomar Medical to Market Quantel's SINON Tattoo Removal Laser in the United States and Canada

... to receive a 510(k) over-the-counter (OTC) clearance from the United States Food and Drug ... home use, light-based hair removal device. OTC clearance allows the product to be marketed and sold ... respect to medical devices, including whether FDA clearance will be obtained for future products and ...

Somanetics Announces New FDA 510(K) Clearance

... (Nasdaq: SMTS ) announced today a new 510(k) clearance from the U.S. Food and Drug Administration (FDA) ... patient population, in addition to its previous clearance as a trend monitor in any individual. These ... clinical data we submitted and subsequent 510(k) clearance demonstrate that improved patient outcomes are ...

Test quickly assesses whether Alzheimer's drugs are hitting their target

... whether increased A-beta production, reduced clearance or a combination of the two lead to the A-beta ... been a way to directly measure the production or clearance of A-beta. The efficacy of potential new ... altered leucine dropped, revealing the A-beta clearance rate. The results suggest a dose-dependent ...

New studies examine elimination of hepatitis B and C

... with chronic HCV, HBV superinfection can lead to clearance of the HCV. They compared 29 HCV patients to ... although life-threatening, may lead to a clearance of chronic HCV infection," the authors report. ... reduction of HBsAg serum levels leading to HBsAg clearance is the hallmark of a newly achieved immune ...

Response Biomedical Corporation Reports 2008 Financial Results

... in 2009 and beyond. We also received regulatory clearance for the Flu A+B product that 3M launched in the ... a key U.S. Food and Drug Administration (FDA) clearance to market our NT-proBNP diagnostic test, which ... are preparing the data to submit for regulatory clearance to the FDA. We are hopeful that we will have ...

Cardium Reports on Recent Highlights, Financial Results and 2009 Outlook

... prostate cancer. An application for FDA 510(k) clearance of the UroCool(TM) system was submitted in the ... U.S. Food and Drug Administration (FDA) 510(k) clearance to market the RapidBlue(TM) System, an ... 2003 and a regulatory application for FDA 510(k) clearance of the UroCool catheter was submitted in the ...

New Laser Combo Therapy Zaps Acne

... laser energy but without ALA PDT. Complete clearance of acne was achieved in all 14 people in the ALA ... be the first such treatment to achieve complete clearance of acne up to 13 months post-treatment and a 77 percent clearance rate per treatment," the study's author, Dr. ...

Palomar Medical to Debut New Devices and a More Powerful Platform at the American Academy of Dermatology Annual Meeting

... of micro-damage. Palomar intends to seek FDA clearance for this device in the near future and begin ... to receive a 510(k) over-the-counter (OTC) clearance from the United States Food and Drug ... home use, light-based hair removal device. OTC clearance allows the product to be marketed and sold ...

FDA Clears New Skin and Surface Treatment Applicator for Use With Xoft's Axxent(R) Electronic Brachytherapy (eBx) System

... Xoft, Inc., today announced that it has received clearance from the U.S. Food & Drug Administration ... Radiation Therapy (IORT). This latest FDA clearance allows the applicator to be used on any external ... our breast and endometrial applications, the FDA clearance of skin and surface indications completely ...

SuperGen Reports 2008 Fourth Quarter and Year-End Financial Results

... scientific forums. The Company received clearance from the Food and Drug Administration, or FDA, to ... The Company announced it received clearance from the FDA to initiate clinical trials with SGI-1776, an inhibitor of PIM kinases. The clearance of the IND triggered a $5.2 million milestone ...

Derma Sciences Gains FDA Clearance for Novel BIOGUARD(TM) Barrier Dressing with NIMBUS(R) Technology

... first BIOGUARD Barrier Dressings have received clearance from the U.S. Food and Drug Administration for ... Derma Sciences' CEO Ed Quilty stated, "This clearance represents a significant milestone for Derma ... Sciences in 2007. This represents the first FDA clearance for a product with NIMBUS - an innovative ...

Palomar Medical Reports Financial Results for Fourth Quarter and Fiscal Year 2008

... to receive a 510(k) over-the-counter (OTC) clearance from the United States Food and Drug ... home-use, light-based hair removal device. OTC clearance allows the product to be marketed and sold ... respect to medical devices, including whether FDA clearance will be obtained for future products and ...

Alma Lasers Announces FDA Clearance of the UniForm Handpiece

... aesthetic devices, announced today the FDA clearance and immediate availability of the UniForm ... device. The UniForm has received FDA clearance for "the temporary reduction in the appearance of ... "We are extremely excited to announce the FDA's clearance of the UniForm handpiece as it offers patients a ...

Mindray Medical Achieves 2008 Product Development Goals and Announces Strong Pipeline for 2009

... US Food and Drug Administration ("FDA") 510(k) clearance for nine products, including the Beneview ... company. To date, Mindray has received FDA 510(k) clearance for a total of 28 products, covering patient ... in 2009 the company will apply for FDA 510(k) clearance for four products. Upon approval, these products ...

Video: Solta Medical Introduces Advanced Thermage Body Tip 16.0 for Faster Body Shaping and Contouring Treatments

... received European CE Mark approval and received clearance from the U.S. Food and Drug Administration in ... All our claims are based upon our FDA clearance for the non-invasive treatment of wrinkles and ... the upper and lower eyelids, and our FDA clearance for the temporary improvement in the appearance ...

Medicsight PLC Presents New Data at RSNA 2008 Further Supporting Relevance of Computer-Aided Detection (CAD) and Image Analysis Software in Early Colon Cancer Screening and Diagnosis

... has recently submitted its application for 510(k) clearance to the U.S. Food and Drug Administration (FDA) ... is anticipating an FDA decision on granting clearance for distribution early 2009. If granted ... use in Japan by end of 2008 and the U.S., pending clearance by the FDA, during the first half of 2009. The ...

New Study Data: JANUVIA™ (sitagliptin) Significantly Reduced Blood Sugar Levels and Was Not Associated with Hypoglycemia in Elderly Patients with Type 2 Diabetes

... with mild renal insufficiency (creatinine clearance [CrCl >=50mL/min, approximately corresponding to ... JANUVIA and periodically thereafter. Creatinine clearance can be estimated from serum creatinine using the ... was approximately 12.4 hours and renal clearance was approximately 350mL/min. Elimination of ...

FDA Clears the DPL (Deep Penetrating Light) Therapy System for Over-the-Counter - Home Use

... LED Technologies, LLC has received FDA clearance for their DPL™ Therapy System for temporary ... increase local blood circulation. This clearance launches the way for the DPL™ Therapy ... without a prescription. "This FDA clearance marks a considerable landmark for our company as ...

Interferon Reduces, Eliminates Viral Infections in Heart Failure Patients

... assay. Schultheiss said IFNB-1b resulted in clearance of all enteroviruses and adenoviruses, but noted ... the primary endpoint, only patients with complete clearance of both viruses were calculated as responders. This resulted in clearance rates of 40 percent and 50 percent in the ...

Palomar Medical Reports Financial Results for Third Quarter 2008

... to receive a 510(k) over-the-counter (OTC) clearance from the United States Food and ... home-use, light-based hair removal device. OTC clearance allows the product to be marketed and ... to medical devices, including whether FDA clearance will be obtained for future products and ...

CMS, Inc., an Elekta Company, Receives FDA 510(k) Clearance for Atlas-Based Autosegmentation Software

... management solutions, has received FDA 510(k) clearance for its new Atlas-Based Autosegmentation (ABAS) product. This clearance allows CMS to immediately begin distributing ... are extremely proud and very pleased to receive clearance to distribute Atlas-Based Autosegmentation to the ...

Study Lets Teens Sound Off on Acne Therapies

... ($100) than they'd pay to have 50-percent clearance of their acne ($10) or to have clear skin with ... Thus, adolescents' marked preference for total clearance over partial (50 percent) clearance ...

FDA Grants AMDL Clearance to Market the AMDL-ELISA DR-70(R) (FDP) Blood Test for Monitoring Colorectal Cancer

... to an existing predicate device and granted clearance to market the AMDL-ELISA DR-70(R) (FDP) as a safe ... of 2012 (Kalorama Research Group: 2008). The FDA clearance to market was based upon data showing DR-70 (FDP) ... are biopsy confirmed with this disease. "This clearance to market provides CRC patients with access to ...
Other Contents
(Date:7/30/2014)... increase in Impact Factors for its molecular bioscience ... (Thomson Reuters, 2014) show that Clinical Science ... Biochemistry , Biochemical Society Transactions and ... their Impact Factors. The journals are owned by ... Limited. , 2014 Impact Factors (2013 Impact Factor ...
(Date:7/30/2014)... Brembs, professor of neurogenetics at the Institute of Zoology, ... readers and reviewers to run the underlying code within ... forward for scientific publishing, by demonstrating a completely novel ... , Figure 3 in fact doesn,t really exist. The ... F1000Research , and the figure is generated ,on the ...
(Date:7/30/2014)... use of iodine-125 (125I) in cancer treatment has ... root ganglia are critical for neural transmission between ... Zhang and colleagues from Institute of Radiation Medicine, ... 125I could be implanted into rat dorsal root ... 125I seeds with different radioactivity (0, 14.8, 29.6 ...
Breaking Biology News(10 mins):Across-the-board Impact Factor increases for Portland Press Limited 2F1000Research brings static research figures to life 2
(Date:7/31/2014)... (PRWEB) July 31, 2014 Cheerag ... experienced, sub-specialty trained neurosurgeons at the Saint Luke’s ... Spine Program and director of spine surgery. He comes ... Wash. , “Dr. Upadhyaya has been recognized for his ... complex spine issues. His addition to the Saint Luke’s ...
(Date:7/31/2014)... (PRWEB) July 31, 2014 What’s ... practice provider? Community Health Center of Snohomish answers ... Pediatricians vs. Family Doctors ”. Many adults can ... available to them. Community Health Center hopes to ... and differences between the two. , To ...
(Date:7/31/2014)... Bellava MedAesthetics is proud to introduce ... surgeon! , Dr. Kim has more than a ... the look of their dreams. He focuses on natural ... augmentation (including Gummy Bear implants ), laser liposuction, ... Brazilian butt lift), abdominoplasty (tummy tuck), rhinoplasty, blepharoplasty (eyelid ...
(Date:7/31/2014)... 2014 When it comes to aesthetics ... and improve. As such, Natalie Sharp's Pure Vitality ... for a new, more focused direction and to provide ... patients! , Pure Vitality Rx is Oyster Bay's premier ... wide variety of services primarily dedicated to women. Services ...
(Date:7/31/2014)... Boston, MA (PRWEB) July 31, 2014 Many ... fight for the weak, to correct injustices, and preserve the ... - action that can be lauded as crusading and exemplary ... the lawyer takes on corruption whose seed might be planted ... a fury and the ultimate punishment for an attorney - ...
Breaking Medicine News(10 mins):Health News:Saint Luke’s Marion Bloch Neuroscience Institute welcomes Cheerag D. Upadhyaya, M.D., as director of Spine Program 2Health News:Saint Luke’s Marion Bloch Neuroscience Institute welcomes Cheerag D. Upadhyaya, M.D., as director of Spine Program 3Health News:Saint Luke’s Marion Bloch Neuroscience Institute welcomes Cheerag D. Upadhyaya, M.D., as director of Spine Program 4Health News:Community Health Center of Snohomish County Reveals the Differences Between Pediatricians and Family Practice Providers 2Health News:Bellava MedAesthetics Welcomes Dr. Chang Soo Kim as Its New Westchester Plastic Surgeon 2Health News:Natalie Sharp's Pure Vitality Rx Upgrade - Partnership With Shangri-La Spa and Website Facelift! 2Health News:Supreme Court Press Petition of the Month for July 2014: Shutting Down Inconvenient Lawyers By Disbarment or Suspension 2Health News:Supreme Court Press Petition of the Month for July 2014: Shutting Down Inconvenient Lawyers By Disbarment or Suspension 3
Other TagsOther Tags