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CryoLife responds to Medafor's allegation on repudiation of exclusive distribution agreement

CryoLife, Inc., an implantable biological medical device and cardiovascular tissue processing company, today responded to Medafor's allegation that it has repudiated the Exclusive Distribution Agreement between the two companies.

19 Mar 2010

FDA categorizes Nanosphere's RVNATSP assay on Verigene SP System as "Moderate Complexity"

Nanosphere, Inc., a leader in the development and commercialization of advanced molecular diagnostics systems, received notification from the U.S. Food and Drug Administration (FDA) that its respiratory virus panel (RVNATSP) performed on the Verigene SP System has been categorized as "Moderate Complexity" under the Clinical Laboratory Improvement Amendments of 1988 (CLIA).

19 Mar 2010

Researchers use optogenetics technology to troubleshoot neural circuits

Recently, brain researchers have gained a powerful new way to troubleshoot neural circuits associated with depression, Parkinson's disease and other conditions in small animals such as rats. They use an optogenetics technology, invented at Stanford University, that precisely turns select brain cells on or off with flashes of light. Although useful, the optogenetics tool set has been limited.

19 Mar 2010

FDA approves expanded indication for Boston Scientific's CRT-Ds

Boston Scientific Corporation today announced that the Circulatory System Devices Panel of the U.S. Food and Drug Administration (FDA) has unanimously recommended approval of an expanded indication for its cardiac resynchronization therapy defibrillators (CRT-Ds), including the COGNIS® CRT-D. The panel recommended the expansion include the majority of the studied population of the landmark MADIT-CRT clinical trial, which evaluated the ability of these devices to slow the progression of heart failure in patients with asymptomatic or mild heart failure.

19 Mar 2010

Advaxis publishes new findings on Listeria-derived ActA anti-cancer component

Advaxis, Inc., the live, attenuated Listeria monocytogenes (Listeria) immunotherapy company, has published new research findings on ActA as a potential, anti-cancer component and a new complement to the Company’s evolving proprietary Listeria technology platform.

19 Mar 2010

Physician scientists present new findings on aspirin therapy, atrial fibrillation drug therapy and LVAD

Physician scientists from the Cedars-Sinai Heart Institute presented new findings on the effectiveness of routine aspirin therapy for preventing heart disease, a drug therapy for atrial fibrillation and the role left ventricular assist devices may play in weight reduction for obese patients with chronic end-stage heart failure who are considered for heart transplantation.

19 Mar 2010

BioSense Technologies' Z-Sense Differential Impedance Sensing diagnostic system rapidly identifies drug susceptibility

BioSense Technologies, a pioneer in the development of diagnostic systems for rapid drug susceptibility testing, announced today that it presented key scientific findings at the National Foundation for Infection Disease 2010 Annual Conference on Antimicrobial Resistance, held in Bethesda, MD in early February.

19 Mar 2010

BioImagene's Virtuoso software integrated with anatomic pathology LIS

BioImagene, Inc., the leading provider of end-to-end digital pathology solutions, announced the integration of Virtuoso™, BioImagene’s digital pathology workflow software, with several market-leading anatomic pathology laboratory information systems.

From Elekta 19 Mar 2010

Atritech to initiate confirmatory study of WATCHMAN LAA Closure Device

Atritech, Inc., an emerging medical device company, announced today that it has obtained clarity from the U.S. Food and Drug Agency on the regulatory path towards full approval of its WATCHMAN® Left Atrial Appendage Closure Technology in the United States.

19 Mar 2010

Haemonetics announces reagent agreement with Quotient Biodiagnostics and Alba Bioscience

Haemonetics Corporation, a global blood management solutions company, today announced that it has entered into a reagent development and supply agreement with Quotient Biodiagnostics Group and its wholly owned subsidiary Alba Bioscience Limited. This arrangement provides Haemonetics with exclusive access to Alba's comprehensive catalogue of approved reagents for use in connection with the commercialization of its Arryx laser based blood typing platform.

19 Mar 2010

Norgen Biotek launches over 30 new kits for NA based diagnostics

Norgen Biotek Corp., an innovative privately held Canadian biotechnology company focusing primarily on advancing powerful tools for nucleic acids (NA) and protein purification, today announced the launch of over 30 new kits for nucleic-acid based diagnostics. Norgen makes best-in-class kits for nucleic acid and protein sample preparation, and has recognized that high quality sample preparation is the key to high quality diagnostics.

19 Mar 2010

Cameron Health initiates clinical trial of minimally invasive S-ICD System for patients at risk of SCA

Cameron Health, Inc. today announced the commencement of the company's pivotal clinical trial to gain U.S. approval of its Subcutaneous Implantable Defibrillator (S-ICD®) System. The minimally invasive S-ICD System is prescribed for use in patients at risk of Sudden Cardiac Arrest (SCA). The S-ICD System is unique in that the implantation of the system is entirely subcutaneous; no leads are in or on the heart.

19 Mar 2010

Malvern image analysis system measures sub-visible particulates in biotherapeutics

Specialists at Malvern Panalytical have demonstrated the application of dynamic particle image analysis to the measurement of sub-visible particulates in biological therapeutics, using the Sysmex FPIA-3000 particle characterization system.

From Malvern Panalytical 18 Mar 2010

Proteacel acquires exclusive rights to PORE technology from Moffitt Cancer Center

Moffitt Cancer Center and Proteacel LLC announced today that they have entered a licensing agreement under which Proteacel has acquired the exclusive rights to the PORE™ technology for delivery of genes into cells.

18 Mar 2010

U.S.-based CRO licenses NewCardio's QTinno software solution for automating cardiac safety analysis

NewCardio, Inc., a cardiac diagnostic technology provider, announced today that a U.S.-based CRO that provides early phase and specialty clinical drug development services to the pharmaceutical industry, has signed an MSA, licensing NewCardio's QTinno™ software solution in order to deliver fully automated cardiac safety analysis in early phase QT studies.

18 Mar 2010

Humedica, Anceta unveil health care data solutions at AMGA 2010 Annual Conference

Humedica, a next-generation clinical informatics company, and Anceta, the healthcare informatics subsidiary of the American Medical Group Association, today announced the launch of Humedica MinedShare™ Ambulatory as well as AMGA’s Anceta Collaborative Data Warehouse at the AMGA 2010 Annual Conference, taking place now through March 20 in New Orleans.

18 Mar 2010

Solos Endoscopy secures U.S. Trademark for MammoView name

Solos Endoscopy, Inc. is pleased to announce the Company has secured the U.S. Trademark for the MammoView® name. The MamoView® Breast Endoscopy System offers a state-of-the-art endoscopic technology for detecting early stage breast cancer. The Company's Breast Endoscopy System employs advanced micro endoscopes and optical technology to give physicians sharp, clear images of the milk ducts, where the majority of breast cancers arise.

18 Mar 2010

SciQuest introduces PBA methodology for Life Sciences to improve procurement operations

SciQuest, Inc., the global software leader empowering enterprises to realize the potential of strategic procurement, today unveiled a comprehensive methodology that provides leaders with a framework to build and execute a sound business plan to improve existing procurement processes, systems and protocol. This new service, the Procurement Business Assessment (PBA), enables life sciences companies to quickly uncover cost-saving opportunities in their procurement operations.

18 Mar 2010

Tissue micro-processing solutions at volumes <1mL

At Analytica 2010 in Munich, Germany, Seward Ltd will demonstrate its small tissue processing solutions in Hall B2, Stand 130. This range includes the Stomacher® 80 microbag, designed specifically for use in the Stomacher 80 microBiomaster to prepare and process biological samples at volumes as low as 250µL to 5 mL.

18 Mar 2010

EndoChoice launches new CEU Video Program for reprocessing endoscopes

EndoChoice, Inc. strengthens its position as the leader in endoscopy industry with the launch of a new CEU program and a complete line of products focused on efficient and effective endoscope reprocessing.

18 Mar 2010

Device / Technology News

CryoLife responds to Medafor's allegation on repudiation of exclusive distribution agreement

FDA categorizes Nanosphere's RVNATSP assay on Verigene SP System as "Moderate Complexity"

Researchers use optogenetics technology to troubleshoot neural circuits

FDA approves expanded indication for Boston Scientific's CRT-Ds

Advaxis publishes new findings on Listeria-derived ActA anti-cancer component

Physician scientists present new findings on aspirin therapy, atrial fibrillation drug therapy and LVAD

BioSense Technologies' Z-Sense Differential Impedance Sensing diagnostic system rapidly identifies drug susceptibility

BioImagene's Virtuoso software integrated with anatomic pathology LIS

Atritech to initiate confirmatory study of WATCHMAN LAA Closure Device

Haemonetics announces reagent agreement with Quotient Biodiagnostics and Alba Bioscience

Norgen Biotek launches over 30 new kits for NA based diagnostics

Cameron Health initiates clinical trial of minimally invasive S-ICD System for patients at risk of SCA

Malvern image analysis system measures sub-visible particulates in biotherapeutics

Proteacel acquires exclusive rights to PORE technology from Moffitt Cancer Center

U.S.-based CRO licenses NewCardio's QTinno software solution for automating cardiac safety analysis

Humedica, Anceta unveil health care data solutions at AMGA 2010 Annual Conference

Solos Endoscopy secures U.S. Trademark for MammoView name

SciQuest introduces PBA methodology for Life Sciences to improve procurement operations

Tissue micro-processing solutions at volumes <1mL

EndoChoice launches new CEU Video Program for reprocessing endoscopes

Real-time Raman monitoring for pharmaceutical hot melt extrusion

Synthetic Psychedelics: A Growing Public Health Concern

How the Vutara VXL simplifies single-molecule imaging

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