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Clearance in Biological Technology

Sundia Shortens CRO Shipment Delivery Time with Express Customs Clearance in Shanghai

... -- Since the implementation of Express Customs clearance on a trial basis a month ago for Sundia MediTech ... CRO companies to ensure a smooth declaration and clearance process. This new customs clearance model will be implemented for more CRO companies ...

EMcision Announces 510(k) Clearance of the Habib EndoHPB, its Novel Bipolar RF Device for the Palliation of Biliary and Pancreatic Tumours

... EMcision Ltd. today announced clearance for marketing by the United States Food and Drug ... July 14, 2009 -- EMcision Ltd. today announced clearance for marketing by the United States Food and Drug ... stent patency by delaying tumour growth. 2) clearance of obstructed metal stents: Self-expanding mesh ...

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

... products for microbiology labs, has received clearance from the U.S. Food and Drug Administration (FDA) ... it becomes systemic. "This is the second FDA clearance we have received this year for our YeastOne ... committed to taking our products through the FDA clearance process where feasible and appropriate. Because ...

New Report Just Published: World Prostate Cancer Therapeutics Market Report

... Late-Stage Prostate Cancer II-62 Protox Gains clearance from FDA to Conduct Phase I Trial of PRX302 ... 2 Clinical Study II-64 Cytogen Receives FDA clearance for CYT-500 IND Application II-64 US ... Takeover Valera II-82 Oncobionic Receives FDA clearance for Cancer Treatment Technology II-82 Misonix ...

Sundia and 2 Other CRO Companies Granted Express Customs Clearance Privilege in Shanghai

... Hi-Tech Park to initiate the Express Customs clearance for 3 biopharmaceutical R&D outsourcing (CRO) ... start of the trial operation of a new customs clearance model for CRO companies in Zhangjiang. ... the rapid growth of the CRO industry, customs clearance efficiency becomes a significant bottleneck for ...

Osteotech Reports Fourth Quarter and Full Year 2008 Financial Results; Company Plans Three Product Launches and Unveilings in 2009; Will Provide 2009 Guidance During Conference Call on March 5, 2009 at 9:00 a.m. EST

... to file a 510(k) with the FDA to secure marketing clearance for DuraTech in the third quarter of 2009. ... In October 2008, Osteotech received FDA clearance for its next generation grafting material, ... In April 2008, Osteotech received FDA clearance to market its Plexur P(R) Biocomposite in spinal ...

Serica Technologies Receives FDA 510(k) Clearance for SeriScaffold(TM) Technology for Soft Tissue Repair

... today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) ... technology. "We are delighted to receive FDA clearance under the 510(k) process. This 510(k) clearance represents a major milestone for Serica as well ...

Beckman Coulter Announces Fourth Quarter and Full Year 2008 Results; Earnings Outlook Achieved on Strong Fundamentals

... Received FDA clearance for the UniCel(R) DxH 800 Cellular Analysis ... mix and volume requirements. Received FDA clearance for the Access(R) Soluble Transferrin Receptor ... agreements have not received regulatory clearance and are still in the development stage, ...

Palomar and Q-MED AB Terminate International Distribution Agreement

... 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 ...

SuperGen Receives Clearance to Begin Clinical Trials With SGI-1776, a PIM Inhibitor

... with SGI-1776, an inhibitor of Pim kinases. The clearance of its Original Investigational New Drug ... "We are pleased to acknowledge FDA's clearance of our IND application to enter what we believe ... President and Chief Executive Officer. "The clearance of the SGI-1776 IND application represents a ...

Cardium Reports on Third Quarter 2008 Financial Results and Revised Business Strategies for Operating Units

... Inc. The Company recently announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) ... 2003 and a regulatory application for FDA 510(k) clearance of the UroCool(TM) catheter is expected to be ... treatment. Commentary "The recent FDA 510(k) clearance for our RapidBlue System, which we believe is the ...

Cardica Announces Fiscal 2009 First Quarter Financial Results

... Proximal Anastomosis System Received 510(k) clearance from U.S. Food and Drug ... 2008. "We had an excellent quarter with the FDA clearance of our PAS-Port(R) Proximal Anastomosis System ... Commercial Accomplishments -- Received 510(k) clearance from the FDA for the PAS-Port(R) ...

onTargetjobs and ClearedConnections Announce Online Recruitment Partnership

... candidates with an active U.S. Security clearance who utilize the onTargetjobs network of niche ... intelligence jobs or federal government security clearance jobs now available to jobseekers for viewing on ... identifies individuals with an active Security clearance and facilitates an introduction to ...

BioForm Reports Financial Results for the Fourth Quarter and Full Fiscal Year Ended June 30, 2008

... has recently received an additional 510(k) clearance for a new treatment profile software upgrade ... intended to support an FDA application seeking clearance to market this product for the treatment of ... or to advance a clinical program for regulatory clearance of the product in the United States, the ...

Ovalum Ltd. Received Clearance to Market the CiTop™ Product-Line in Israel

... Following FDA clearance and CE approval, revolutionary CiTop™ ... medical device company, has announced today the clearance to market of its unique CiTop™ product-line ... medical device company, has announced today the clearance to market of its unique CiTop™ product-line ...

Cardium's InnerCool Therapies Unit Announces Italian Commercialization Agreement for Portfolio of Temperature Modulation Systems

... Celsius Control System has received FDA 510(k) clearance for use in inducing, maintaining and reversing ... care. The system has also received FDA clearance for use in cardiac patients in order to achieve ... temperature modulation is expected to receive FDA clearance in the second quarter 2008, and to initially have ...

FDA Clears New Applicators for Endometrial Cancer Treatment With Xoft's Axxent(R) Electronic Brachytherapy System

... Second Treatment Indication on Heels of Multi-Use clearance for Axxent(R) System Strengthens the Creation ... Xoft, Inc., today announced that it has received clearance from the U.S. Food & Drug Administration (FDA) ... settings, also recently received expanded FDA clearance for use in the treatment of other cancers or ...

CorMatrix(R) Announces FDA 510(k) for Novel Biomaterial Implant for Intracardiac Repair

... that the company has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) ... applications. The company has U.S. and European clearance to market the CorMatrix ECM Technology(TM) as an implant for pericardial closure and clearance in the U.S. for cardiac tissue repair. CorMatrix ...

Cardium Reports on Science Channel Series Featuring InnerCool's Endovascular Cooling During Brain Surgery at Stanford University

... Celsius Control System has received FDA 510(k) clearance for use in inducing, maintaining and reversing ... intensive care. The system has also received FDA clearance for use in cardiac patients in order to ... temperature modulation is expected to receive FDA clearance in the second quarter 2008, and to initially have ...

Cardium's InnerCool Therapies Unit Announces European Commercialization Agreement for Portfolio of Temperature Modulation Systems

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

FDA Clears Expanded Use of Xoft's Axxent(R) Electronic Brachytherapy System for all Radiation Therapy Indications

... FDA clearance Validates Platform Designed to Deliver Electronic ... today announced that it has received expanded clearance from the U.S. Food & Drug Administration (FDA) ... alternative of a full mastectomy. "The expanded clearance for the Axxent Controller is very significant in ...

Cepheid Reports Fourth Quarter and Full Year 2007 Results

... release of the Xpert HemosIL test -- FDA clearance of the Xpert MRSA/SA test for SSTI -- FDA clearance of the Xpert MRSA/SA test for blood culture -- FDA clearance of the Xpert HemosIL test -- European release of ...

Escalon(R) Announces FDA 510(K) Clearance for VascuView(TM) Visual Ultrasound System For Assisted Vascular Access

... Extends Product Portoflio with Third FDA Market clearance Since December 2007 ... ) today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) ... "We are excited to announce the FDA clearance and introduction of the new VascuView(TM) Visual ...

Palomar and Q-MED AB Enter Into International Distribution Agreement

... 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 ... respect to medical devices, including whether FDA clearance will be obtained for future products and ...

Amedica Receives FDA 510(k) Clearance for Valeo(TM) Cervical Plate

... Drug Administration has granted 510(k) marketing clearance to Amedica's Valeo(TM) Cervical Plate system. ... "We are extremely pleased to receive FDA clearance of the Valeo CP system," said Ashok Khandkar, ... Executive Officer of Amedica Corporation. "The clearance of this implant represents another ...

CardioDynamics Receives FDA 510(k) Clearance for Innovative Clinical Parameters and Electronic Medical Record Compatibility

... today announced the Company has received market clearance from the U.S. Food and Drug Administration (FDA) ... Medicare. The Company also announced FDA 510(k) clearance for expanded BioZ Dx EMR interface capability. By ... "We are very pleased to receive FDA 510(k) clearance for these BioZ Dx enhancements. As the innovator ...

YM BIOSCIENCES REPORTS 2007 YEAR END OPERATIONAL AND FINANCIAL RESULTS

... of $16.2 million. - YM BioSciences USA received clearance from the US Treasury Department to import nimotuzumab into the US - Daiichi Sankyo received clearance to initiate a clinical trial with the drug in ... and safety, will be reported. - YM received clearance to initiate a clinical trial in children with ...

Angiotech Pharmaceuticals, Inc. announces financial results for the second quarter ended June 30, 2009

... the United States Food and Drug Administration ("FDA") had granted 510(k) clearance for the Option(TM) Inferior Vena Cava ("IVC") Filter, for use in both ... We made a milestone payment of $2.5 million to Rex Medical upon 510(k) clearance of the Option IVC Filter during the second quarter of 2009 and recorded ...

New Report Just Published: World Endoscopy Systems Market Report

... is Now Solos Endoscopy II-50 Advanced Sterilization Obtains FDA clearance II-50 STERIS Obtains FDA Approval For Reliance EPS II-50 Solos Endoscopy Files For FDA clearance of OvaScope(TM) and MastaScope(TM) II-50 ACMI Establishes GSS ...

EyeIC Receives FDA 510(k) Clearance for MatchedFlicker(TM) Retinal Aid Detection Technology

... today that its MatchedFlicker(TM) technology has received FDA 510(k) clearance from the United States Food & Drug Administration (FDA). ... and its founder. "We are extremely pleased with EyeIC's the 510(k) clearance for MatchedFlicker," said Michael B. Aronson, a Board Member of the ...

Angiotech Pharmaceuticals announces FDA 510(k) clearance of the Option(TM) Inferior Vena Cava Filter

... that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the Option(TM) Inferior Vena Cava (IVC) Filter in the United States, ... Filter if necessary or where mandated clinically). "This important FDA clearance of the Option IVC Filter continues Angiotech's mission of offering the ...

EarlySense's EverOn(TM) System Receives FDA Clearance and CE Mark Certification

... or clinical setting. In November 2007, EarlySense announced the FDA clearance of the ES-16, the predecessor of the EverOn system. EverOn is a ... health and support improved medical decision making. "Today's FDA clearance and CE Mark news further validates our technology. There is an ...

Johnson & Johnson Begins Tender Offer to Acquire Cougar Biotechnology

... common stock on a fully diluted basis. The closing is also conditioned on clearance under the Hart-Scott-Rodino Antitrust Improvements Act and other customary ... the satisfaction of closing conditions for the acquisition, including clearance under the Hart-Scott-Rodino Antitrust Improvements Act; the tender of a ...

Astellas Receives FDA Approval for Use of Prograf(R) (Tacrolimus) in Conjunction With Mycophenolate Mofetil (MMF) in Kidney Transplant Recipients

... Patients in the Prograf group exhibited higher estimated creatinine clearance rates (eCLcr) using the Cockcroft-Gault formula and experienced fewer ... CyA/MMF (36.2% and 31.6%) and Siro/MMF (46.4%). Median creatinine clearance rate, a measure of kidney function (eCLcr) at 12 months was higher in the ...

Johnson & Johnson Announces Definitive Agreement to Acquire Cougar Biotechnology, Inc.

... of Cougar Biotechnology's common stock. The closing is conditioned on clearance under the Hart-Scott-Rodino Antitrust Improvements Act and other customary ... the satisfaction of closing conditions for the acquisition, including clearance under the Hart-Scott-Rodino Antitrust Improvements Act; the tender of a ...

Signostics Receives FDA Clearance for World's Smallest Ultrasound Product

... medical device company Signostics announced today it has secured clearance from the U.S. Food and Drug Administration (FDA) for its palm-sized ... billion, with the U.S. market worth about $1 billion. "Securing FDA clearance is a huge milestone for our company," Dr. Bartlett said. "The global ...

Medarex Announces 2009 First Quarter Financial Results

... 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. ...

NovaBay Pharmaceuticals, Inc. Announces Fourth Quarter and Full Year 2008 Financial Results

... NovaBay's lead Aganocide compound, after receiving clearance of an Investigational New Drug (IND) application from the U.S. Food and Drug Administration in January 2009. The IND clearance triggered an immediate milestone payment of $1 million from Alcon to ...

Masimo Initiates Full Market Release of First-Ever Noninvasive Continuous Hemoglobin Monitor

... and continuous hemoglobin monitoring technology to receive FDA 510(k) clearance and be available for widespread commercial adoption, Masimo SpHb is ... making, improve care, and reduce costs." SpHb has received regulatory clearance in the U.S., Canada, Europe and Australia, and is now available for sale ...

Spectral announces 2008 financial results

... of care in European trials. Spectral's current focus is to seek FDA clearance for the therapeutic product." Highlights from 2008: - ... in the U.S. for Toraymyxin(TM). The Company will now seek FDA clearance for this product. The final license and supply agreement with ...
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(Date:7/28/2014)... approved by the U.S. Food and Drug Administration (FDA) ... certain bacterial pathogens inside human cells, including those that ... findings, published in mBio , the online open-access ... new way of identifying non-antibiotic drugs that could one ... of drugs on the list inhibit the growth of ...
(Date:7/28/2014)... a circulatory problem of the legs called peripheral vascular ... surgery in serious cases. This disease can lead to ... , At The University of Texas Health Science Center ... preventative treatment in a mouse model of the disease ... Their proof-of-concept study appears in the journal Cell ...
(Date:7/28/2014)... suggests that the effects of a commonly used anesthetic ... , The study, published in this week,s issue of ... biologists at the University of California, San Diego and ... to concerns, arising from multiple studies on humans over ... may increase their susceptibility to long-term cognitive and behavioral ...
Breaking Biology News(10 mins):New route to identify drugs that can fight bacterial infections 2Scientists discover genetic switch that can prevent peripheral vascular disease in mice 2Study suggests disruptive effects of anesthesia on brain cell connections are temporary 2Study suggests disruptive effects of anesthesia on brain cell connections are temporary 3
(Date:7/29/2014)... Winter is here down under, and it ... central business district. That is, until a troop of ... otherwise ordinary day into a celebration—a celebration of drug-free ... of The Truth About Drugs, a drug prevention initiative ... woke up the city with a rousing performance of ...
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(Date:7/29/2014)... Advertising claims for cosmetic procedures using stem cells are ... and effectiveness, according to a review in the August ... , the official medical journal of the American ... offer tremendous potential, but the marketplace is saturated with ... at risk," write Dr Michael T. Longaker of Stanford ...
Breaking Medicine News(10 mins):Health News:Sydney Business District “Rocked” by The Truth About Drugs 2Health News:Get Rid of Cold Sores Fast Review Exposes the Way to Stop Outbreaks 2Health News:How to Reach the Heart of the Perfect Guy with "Enchant Him Program" - a Report by Daily Gossip Magazine 2Health News:Kids Will Pass on 'Healthy' Foods 2Health News:Beware of claims about cosmetic stem cells procedures, says review in Plastic and Reconstructive Surgery 2
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