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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 ...
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(Date:9/2/2014)... Air pollution regulations over the last decade in Taiyuan, ... there, accounting for a greater than 50% reduction in ... 2001 and 2010, according to researchers at the Columbia ... School of Public Health, the Shanxi Medical University, the ... and Shanghai Fudan University School of Public Health. , ...
(Date:9/2/2014)... In Bavaria, the Tithonian Konservat-Lagersttte of lithographic limestone ... discoveries of emblematic fossils from that area (for ... have found fossil insects in the French equivalent ... new species representing the oldest known water treader. ... equivalent Bavarian outcrops, fewer fossils have been obtained ...
(Date:9/2/2014)... stress in stride; others are done in by it. ... mechanisms of this so-called stress gap in mice with ... lead researchers to better understand the development of psychiatric ... each animal has unique experiences as it goes through ... can alter the expression of genes, and as a ...
Breaking Biology News(10 mins):Clean air halves health costs in Chinese city 2Exceptionally well preserved insect fossils from the Rhône Valley 2Discovery hints at why stress is more devastating for some 2Discovery hints at why stress is more devastating for some 3
(Date:9/2/2014)... in California, the percentage undergoing a double mastectomy increased ... not associated with a lower risk of death than ... the September 3 issue of JAMA . The ... one breast was associated with a higher risk of ... , Randomized trials have demonstrated similar survival for patients ...
(Date:9/2/2014)... cancer cells can lay the groundwork for their own ... vessels to send out tumor-welcoming signals, according to a ... the Sept. 2 issue of Nature Communications , ... increased levels of so-called signaling molecules released by breast ... in the lungs and lymph nodes to produce proteins ...
(Date:9/2/2014)... Medex Analytic Services is delighted to ... Coral Springs, Fla. due to their greater than forecasted ... for the 2014 year by distinguishing Medex in the ... a higher level of service and professionalism in the ... the industry has responded.” , The location of the ...
(Date:9/2/2014)... (PRWEB) September 03, 2014 Operators in ... to millions of people annually, arranging care and counsel ... and private enterprises are expected to derive $39.4 billion ... donations and private income. Over the five years through ... annualised rate of 6.6%, including growth of 4.1% in ...
(Date:9/2/2014)... new studies further confirm the health benefits of breast-feeding. ... a lower risk of ear, throat and sinus infections ... similar trend when it comes to allergies. The ... immediate newborn period," said Dr. Jennifer Wu, an obstetrician-gynecologist ... was not involved in the new studies. The ...
Breaking Medicine News(10 mins):Health News:Increase seen in use of double mastectomy 2Health News:Increase seen in use of double mastectomy 3Health News:‘Prepped’ by tumor cells, lymphatic cells encourage breast cancer cells to spread 2Health News:Medex Analytic Services Announces New Location for Corporate Headquarters 2Health News:Community Services in Australia Industry Market Research Report Now Updated by IBISWorld 2Health News:Community Services in Australia Industry Market Research Report Now Updated by IBISWorld 3Health News:More Evidence Breast-Feeding Lowers Child's Risk of Infections, Allergies 2
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