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cleared in Medical News

Inverness Medical Innovations Launches New FDA Cleared C. DIFF QUIK CHEK COMPLETE(TM) Rapid Test

WALTHAM, Mass., March 30 /PRNewswire-FirstCall/ -- Inverness Medical Innovations, Inc. (NYSE: IMA ), a global leader in enabling individuals to take charge of their health at home through the merger of rapid diagnostics and health management, announced today that it will begin marketing and dist...

Clearwater's Canadian at-Home Dizziness Treatment Device Cleared by FDA

The U.S. Food and Drug Administration has cleared DizzyFIX, an at-home treatment for vertigo and dizziness which helps guide patients through the Epley maneuver, for sale in the U.S. Calgary, Canada (PRWEB) September 23, 2008 -- The U.S. Food and Drug Administration has...

OneTouch(R) Ping(TM) Glucose Management System Cleared by FDA

Animas Announces Clearance of Uniquely Integrated Meter/Pump System with Remote Insulin Delivery Capabilities and Compatible Software WEST CHESTER, Pa., July 1 /PRNewswire/ -- Animas Corporation announced today the clearance of its OneTouch(R) Ping(TM) Glucose Management System by the U.S...

CoolTouch Introduces CoolLipo(TM) Laser System, Recently FDA Cleared for Laser-Assisted Lipolysis

ROSEVILLE, Calif., Jan. 7 /PRNewswire/ -- CoolTouch Inc., a pioneering manufacturer of medical lasers, announced today that the CoolLipo(TM) 1320 nm laser system received an additional 510(K) clearance from the U.S. Food and Drug Administration for laser lipolysis or melting fat. The CoolLipo ...

Supratek Pharma Inc. announced today that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for SP1049C for the treatment of metastatic adenocarcinoma of the upper gastrointestinal tract

MONTREAL, Oct. 26 /PRNewswire/ - The IND proposes a randomized Phase III pivotal clinical trial that will compare SP1049C plus Best Supportive Care (BSC) versus BSC alone for the treatment of patients with advanced adenocarcinoma of the esophagus, gastroesophageal junction and stomach who have...

1 in 5 bariatric surgery candidates not psychologically cleared for surgery

Providence, RI A new study by Rhode Island Hospital and Brown University researchers reported that 18 percent of 500 candidates for bariatric surgery did not receive the initial psychiatric clearance for the surgery. The study is the first to examine the reliability of decisions to clear candidat...

Bayer HealthCare Cleared to Acquire Citracal(R)

Addition of Leading Calcium Brand Enriches Consumer Care Division's Key Nutritionals Product Portfolio MORRISTOWN, N.J., Oct. 5 /PRNewswire/ -- Bayer HealthCare (BHC) announced today that its Consumer Care Division has received regulatory approvals necessary to acquire the ...

Investigational New Drug Application for 'Fat Melting' Injections Cleared by the FDA

Clinical trial on injection lipolysis treatment to begin soon NEW YORK, Sept. 4 /PRNewswire-USNewswire/ -- The Aesthetic Surgery Education and Research Foundation (ASERF) announced today that it has received approval from the U.S. Food and Drug Administration to initiate a clinical trial ...

NBTY Acquisition of Julian Graves Unconditionally Cleared

RONKONKOMA, N.Y., July 22 /PRNewswire-FirstCall/ -- NBTY, Inc. (NYSE: NTY ) ( www.NBTY.com ), a leading global manufacturer and marketer of nutritional supplements, today announced that its acquisition of Julian Graves has been unconditionally cleared in the United Kingdom by the provisio...

New Drug to Help Kick Smoking Habit Cleared in UK

Ban on smoking in enclosed public spaces comes into force in the UK on July 1. And for those inveterate smokers who might despair help is at hand. A twice-daily drug, varenicline, (brand name (CHAMPIX), has been given the green light by the National Institute for Health and Clinical Excel...

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cleared in Medical Technology

Pivotal Clinical Data Published for the Only Laser Phototherapy Device Cleared by the FDA for Hair Growth

- Study provides clinical efficacy of the HairMax LaserComb in the treatment of Androgenetic Alopecia in males commonly known as 'male pattern baldness' - BOCA RATON, Fla., April 20 /PRNewswire/ -- Findings of the pivotal clinical trial of the HairMax LaserComb that provided clear evidence ...

Coapt Systems Launches FDA Cleared Novielle Voice (TM) for Restoration of Voice Loss

Milestone Marks Company's Entrance into the Injectable Filler Market PALO ALTO, Calif., Sept. 21 /PRNewswire/ -- Coapt Systems Inc. today announced the launch of its Novielle Voice family of injectable fillers at the 112th annual meeting of the American Academy of Otolaryngology -- Head and ...

Valopicitabine Combined with Standard of Care Cleared Hepatitis C Virus in 72% of Patients Who Completed 12 Weeks of Treatment in a Phase II Trial

~ Valopicitabine achieved both primary and secondary endpoints of study; no negative drug-drug interaction was observed between valopicitabine and ribavirin ~ CAMBRIDGE, Mass., June 12, 2007 /PRNewswire-FirstCall/ -- Idenix Pharmaceuticals, Inc. today announced results from a phase II study design...

First Skin Cancer Patients Treated With Electronic Brachytherapy (eBx) At University of Wisconsin Riverview Cancer Center

...cer, endometrial cancer, and skin cancer, the Axxent eBx System is also FDA cleared for use in the treatment of surface cancers or conditions where radiation t...d rectal indications, the Axxent(R) Electronic Brachytherapy System is also cleared for use in the treatment of other cancers or conditions where radiation the...

First Patient of NOTES Investigational Device Exemption (IDE) Study Successfully Treated With Ethicon Endo-Surgery Devices

... Articulating Biopsy Forceps The devices listed above will be used within an IDE trial approved by the FDA, they are not currently cleared by FDA for commercial distribution. About NOTES NOTES is an investigational approach to minimally invasive surgery, in which external inci...

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

...) published in Gastrointestinal Endoscopy , 98.4% of patients 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 ...

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

...shed in Gastrointestinal Endoscopy , 98.4 percent of patients 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 ...

Three Independent Studies Include the ImmuKnow(R) Assay to Manage and Optimize Immunosuppression Therapy in Transplant Patients

...s and subsequent increases in ImmuKnow with no infections or rejections. The use of the ImmuKnow assay as described in these studies has not been cleared by the U.S. Food & Drug Administration. About ImmuKnow ImmuKnow is a noninvasive biomarker of immune function that assesses cellular...

Living Donor Kidney Transplants Using Alemtuzumab Pre-Conditioning and Tacrolimus Monotherapy: Long-Term Safety and Efficacy

...t;/= 80.6% of recipients remain steroid-free on tacrolimus monotherapy. The use of the ImmuKnow assay as described in these studies has not been cleared by the U.S. Food & Drug Administration. About ImmuKnow ImmuKnow is a noninvasive biomarker of immune function that assesses cell...

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

...ion product, which is mounted on the end of an endoscope 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 ...
cleared in Medical Products

DUR-D Digital Flexible Ureteroscope

Description:...ers superior color, contrast and resolution to Endourologists for the diagnosis and treatment of the upper urinary tract and kidney, and has also been cleared for use as a flexible choledochoscope for laparoscopic procedures....
Company:GYRUS ACMI

Pro Osteon 200R Bone Graft Substitute

Description:... Pro Osteon 200R is a resorbable, osteoconductive matrix consisting of hydroxyapatite and calcium carbonate. Originally cleared for use in oral maxillofacial procedures as a very slow resorbing material, the faster-resorbing Pro Osteon 200R has been FDA indicated as a bone graf...
Company:Biomet, Inc.

Macra® Lipoprotein A Lp(a)

Description:...And numerous studies since the early 1970s have associated elevated levels of Lp(a) with increased risk of coronary artery disease. The Lp(a) assay is cleared under 510(k) for monitoring levels of Lp(a) and for predictive coronary risk assessment....
Company:Inverness Medical Innovations

Homocysteine Kit

Description:...And numerous studies since the early 1970s have associated elevated levels of Lp(a) with increased risk of coronary artery disease. The Lp(a) assay is cleared under 510(k) for monitoring levels of Lp(a) and for predictive coronary risk assessment....
Company:Inverness Medical Innovations

Monitect Multiple Drug Screen Cassette Test

Description:... Simply collect sample, pipette into testing wells and read results. Monitect is a FDA 510K cleared multiple drug screen cassette that can simultaneously test for both drugs and adulterants. It can test from one (1) to five (5) drugs and can be accom...
Company:Branan Medical Corp.

Tag-It™ Cystic Fibrosis Kit

Description:... Tm Bioscience introduces the Tag-It™ Cystic Fibrosis Kit, the first FDA cleared IVD for cystic fibrosis genotyping. With validated performance criteria, this highly accurate and reproducible (>99.9%) assay will provide superior mu...
Company:Tm Bioscience Corporation

WatchMate MR

Description:...odel displays multiple alarms locally without individual identification, but ID numbers and names can be displayed at a central station. Alarms may be cleared locally under password control....
Company:VeriChip Corporation

WatchMate ID

Description:...ltiple alarms locally with resident ID numbers and this information, along with residents names, can be displayed at a central station. Alarms may be cleared locally under password control....
Company:VeriChip Corporation

Erythropoietin RIA Test

Description:...cells and appears to facilitate erythrocyte differentiation, perhaps by increasing survival of the progenitor cells. Endogenous, N-glycosylated EPO is cleared at a constant rate, with a half-life estimated at 1.5 - 2 hours. The clearance rate is largely unaffected by EPO levels or tissue utilization. Therefo...
Company:Diagnostic Systems Laboratories, Inc.

AFP ELISA Test

Description:...ter mid-gestation, a gradual decline in body fluid concentrations occurs after mid-gestation, probably due to a dilutional effect. AFP is effectively cleared by the fetal kidney and is excreted into the amniotic fluid. AFP also appears in the maternal serum, presumably by transplacental transfer and thus AF...
Company:Diagnostic Systems Laboratories, Inc.
cleared in Medical Dictionary

Renal scan

... scan may also be used to assess renovascular hypertension ... Renal Scan . Renal Scan Mag 3. Principle. Numerous drugs are bound and or cleared by ... The normal renal scan shows homogenous uptake through out both kidneys. ... A renal scan is a nuclear medicine exam in which a smal...

Laser therapy

...nd more rapid healing. ... long popular in Europe, laser therapy is now cleared to ... Freedom Laser Therapy provides low-level laser therapy f... laser therapy and ... OUR LOW LEVEL LASER THERAPY DEVICES ARE FDA cleared FOR CERTAIN ... Low level laser therapy effects are biochemical and not...

Glucose tolerance test

... A glucose tolerance test in medical practice is the administration of glucose to determine how quickly it is cleared from the blood. The test is usually used to test for diabetes, insulin resistance, and sometimes reactive hypoglycemia. The glucose is most of...

Glucose test

... A glucose tolerance test in medical practice is the administration of glucose to determine how quickly it is cleared from the blood. The test is usually used to test for diabetes, insulin resistance, and sometimes reactive hypoglycemia. The glucose is most of...

FSH

...al ... In kids, FSH levels are ... order a test for LH when ordering a blood test for FSH . ... The "Ru25 Plus" FSH Menopause Test is a FDA cleared At Home Test for symptoms of ... FSH normally regulates the growth and development of an egg. ... INCIID (pronounced inside) is a nonprofit orga...

Creatinine

...n your blood and urine. ... A BUN-to- creatinine ratio can help ... Creatinine clearance rate (CCr) is the volume of blood plasma that is cleared of ... 4.1 Estimated creatinine clearance rate (eCcr) using Cockcroft-Gault formula ... Creatinine test — Overview covers definition, preparat...
cleared in Biological News

Novel antibody prevents infection by hepatitis C virus

...otected. Subsequently, researchers gave the high-dose of the antibody to the animal that originally received no antibody, and in that case the HCV was cleared from that animal's system. "These results are encouraging as a possible treatment for HCV infected patients, but more work needs to be done before we ...

NASA study says climate adds fuel to Asian wildfire emissions

... In the last decade, Asian farmers have cleared tens of thousands of square miles of forests to accommodate the world's gro... environmental effects of such growth have been significant. Land has to be cleared to grow the crop, and the preferred method is fire. The clearing often occu...

Smoke from cigarettes, cooking oil, wood, shift male cardiovascular system into overdrive

...o secondhand cigarette smoke, wood smoke or cooking oil smoke in separate trials as they sat in a 10-by-10-foot environmental chamber. The researchers cleared the air in the chamber after each trial. They measured respiratory and cardiovascular function, including heart rate variability, breathing and bl...

Smoke from cigarettes, cooking oil, wood, shift male cardiovascular system into overdrive

...o secondhand cigarette smoke, wood smoke or cooking oil smoke in separate trials as they sat in a 10-by-10-foot environmental chamber. The researchers cleared the air in the chamber after each trial. They measured respiratory and cardiovascular function, including heart rate variability, breathing and bl...

The genetics of fear: Study suggests specific genetic variations contribute to anxiety disorders

... gene. This polymorphism can come in two different versions that differ in their length. The shorter version of the gene leads to less serotonin being cleared away and is also associated with higher neuroticism scores and anxious behavior. The COMT enzyme is involved in breaking down dopamine, a brain chemic...

Arsenic and old toenails

...nt from normal that is usually due to physical damage (you stubbed your toe or dropped something on it) or a minor fungal infection that can be easily cleared up by a visit to the doctor." ...

Biofuels boom could fuel rainforest destruction, Stanford researcher warns

... establishing new soy fields or oil palm plantations on degraded or already cleared lands," Gibbs said, "while environmental groups and some scientists point t... woody savannas, grasslands, plantations or agricultural landthat are being cleared to make space for the new cropland. "If biofuels are grown in place of...

Study on wildlife corridors shows how they work over time

... At the Savannah River Site in South Carolina, there are five strange looking "patches" cleared out of the surrounding forest. No, they're not crop circles carved by aliens. They're actually budding longleaf pine forest ecosystems. Biologists...

Replacing corn with perennial grasses improves carbon footprint of biofuels

...tant component of soil health and also influences atmospheric carbon dioxide levels. Whenever the soil is disturbed, as occurs when land is plowed or cleared of vegetation, some of this carbon returns to the atmosphere in the form of carbon dioxide. "From the time that John Deere invented the steel plow...

Ecological impact of African cities

... fact it is change in land use that is the main driver" continues Joy. "The real change is around cities the 'peri-urban' areas where woodlands are cleared for agriculture to feed the new centres of population." She points out "When this is added to the effect on water demand and waste disposal on aquatic...
cleared in Biological Technology

TRIA At-Home Laser Hair Removal Device Cleared by FDA

TRIA is First Entry to Home-Based Device Market Featuring Diode Laser Technology for Hair Removal PLEASANTON, Calif., Feb. 7 /PRNewswire/ -- SpectraGenics, a leader in light-based therapeutic beauty devices, today announced over-the-counter (OTC) clearance from the United...

YM BioSciences USA cleared by US FDA to initiate Phase II clinical trial of nimotuzumab in children with inoperable, recurrent brain cancer

MISSISSAUGA, ON, Aug. 30 /PRNewswire-FirstCall/ - YM BioSciences Inc. (AMEX: YMI , TSX: YM, AIM: YMBA), an oncology company that identifies, develops and commercializes differentiated products for patients worldwide, today announced that its wholly-owned US subsidiary, YM BioSciences USA Inc....

GE Cleared Buy Instrumentarium

WAUKESHA, WI.--GE Medical Systems has received required regulatory approvals for the $2.3 billion acquisition of Instrumentarium Corporation. The company has agreed to divest of two divisions of the company they are acquiring. GE Medical Systems, a medical imaging equipment manufacturer plans to...

United States FDA Clears the REGEN Trial to Test Bioheart's Combination Gene and Stem Cell Therapy in Heart Failure Patients

...ring intelligent devices and biologics that help monitor, diagnose and treat heart failure and cardiovascular diseases announced today that the US FDA cleared a phase I clinical trial for MyoCell SDF-1 (Stromal Derived Factor - 1) to treat congestive heart failure. The REGEN trial will enroll 15 patients in...

FDA Grants First Authorization of a Commercial 2009 H1N1 Flu Test for use During Pandemic Flu Emergency to Quest Diagnostics' Focus Diagnostics Business

...H1N1 influenza virus under certain circumstances. The FDA has not cleared or approved any tests for the identification of the 2009 H1N1 influenza vir...r uncleared medical products or unapproved or uncleared uses of approved or cleared medical products following a determination and declaration of emergency, pr...

Derma Sciences, Inc. Hires the Investor Relations Group

...ffective in a variety of wounds and burns, and was the focus of a positive large-scale randomized controlled trial on leg ulcers. Derma's recently FDA cleared BIOGUARD(TM) Barrier Dressing is the Company's latest new product entrant into the $14 billion global wound care market. The barrier technology was li...

Improving Transfusion Safety: Fenwal, Verax Biomedical Sign Agreement for Rapid, Point-of-Care Bacteria Test

... The Verax PGD(R) test is the only rapid test for the detection of bacteria cleared by the United States Food and Drug Administration (FDA) and CE Marked in Eu...lities are in Worcester, Massachusetts. The Verax PGD(R) test is currently cleared by the FDA as a rapid, qualitative immunoassay for the detection of bacteri...

Cadila Pharmaceuticals Launches Joint Venture With Novavax in India

...cals has focused on novel approaches to cancer management and is the first Indian company to get multiple investigational new drug applications (INDs) cleared by USFDA. The company has state-of-the-art manufacturing facilities conforming to the most stringent international norms at Dholka, Ankleshwar, Kadi a...

FDA Clears Caspofungin (Cancidas(R)) Susceptibility Testing for TREK Sensititre(R) YeastOne(R) in Vitro Diagnostics (IVD) Product Line

...out the Sensititre YeastOne Product Line TREK offers a wide range of FDA cleared and research-use-only (RUO) YeastOne dried microbroth dilution plates with ...n customize plates by selecting from nine antifungal agents, including five cleared antifungal compounds, and specifying format and drug concentrations to crea...

Spectral announces publication demonstrating Toraymyxin(TM) significantly reduces mortality from sepsis in prospective controlled trial

...l Diagnostics Spectral is a leader in the battle against sepsis. Spectral's lead product is its Endotoxin Activity Assay (EAA(TM)), the only FDA cleared assay for the measurement of endotoxin. With the growing awareness for the role of endotoxemia in sepsis and the increasing number of therapies being ...
cleared in Biological Products

MagneGST™ Protein Purification System from Promega

Description:... Particles) are used to isolate GST-tagged protein directly from a crude or cleared lysate using either a manual (requires use of a magnetic stand) or automate...ons: Protein purification of glutathione-S-transferase fusion proteins from cleared or crude E. coli cell lysate....
Company:Promega
cleared in Biological Definition

Synapse

... regulation Following fusion of the synaptic vesicles and release of transmitter molecules into the synaptic cleft, the neurotransmitter is rapidly cleared from the space for recycling by specialized membrane proteins in the pre-synaptic or post-synaptic membrane. This " re-uptake " prevents " desensitiz...
cleared in Biological Dictionary

Tracheae

... diffusing ... Reproduction occurs within the tracheae of adult bees, where female mites may lay 8–20 eggs. ... The tracheae are separated out, cleared with 8% potassium ... The tracheae are long cylindrical dead cells. ... a spacious lumen that extends throughout the length of the trachea ....

Membrane transporter

...ansporter is a membrane -spanning protein that binds the neurotransmitter dopamine; DAT provides the primary mechanism through which dopamine is cleared from synapses, transporting dopamine from the synapse into... Disease Related Membrane Transporters . PharmTao Home ... region 1, candidate A;...
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(Date:7/10/2014)... NEW YORK , June 27, 2014 /PRNewswire/ ... against Provectus Biopharmaceuticals, Inc. ("Provectus" or the "Company")(NYSE-MKT: ... action, filed in United States District Court, Middle ... Division, is on behalf of a class consisting ... otherwise acquired Provectus securities between December 17, 2013 ...
(Date:7/10/2014)... NXT-ID, Inc., (OTCQB: NXTD) a biometric authentication company focused on the growing ... was interviewed on July 1 st on the Downtown ... Mr. Pereira discusses the company,s next generation smart wallet with ... Wocket™ aims to replace a traditional wallet with a new ... tells Gino he has never heard of the Wocket and ...
(Date:7/10/2014)... Fingerprint Cards, (FPC,s) new ... (DW). An Asian OEM has selected FPC1021 for a flagship ... August 2014.   FPC is proud to announce ... planned date for start of mass production in August 2014. ... 5M, for delivery in the first half of July. The ...
Breaking Biology News(10 mins):SHAREHOLDER ALERT: Pomerantz Law Firm Announces the Filing of a Class Action against Provectus Biopharmaceuticals, Inc. and Certain Officers - PVCT 2SHAREHOLDER ALERT: Pomerantz Law Firm Announces the Filing of a Class Action against Provectus Biopharmaceuticals, Inc. and Certain Officers - PVCT 3Security and Your Money: Tampa Bay Radio Host Cedric Harris Talks to NXT-ID CEO Mr. Gino Pereira about the Wocket Smart Wallet 2Security and Your Money: Tampa Bay Radio Host Cedric Harris Talks to NXT-ID CEO Mr. Gino Pereira about the Wocket Smart Wallet 3Security and Your Money: Tampa Bay Radio Host Cedric Harris Talks to NXT-ID CEO Mr. Gino Pereira about the Wocket Smart Wallet 4FPC Wins DW and Initial Ramp Order for FPC1021 Touch Sensor for Flagship Smartphone from Asian OEM 2
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