July 19, 2017 Clinical Research/Diagn. M&A, Partnerships

GE Healthcare Acquires Novia Strategies to expand Clinical Consulting Capabilities and Help More Healthcare Organizations Achieve Breakthrough Outcomes

July 10, 2017 – GE Healthcare (NYSE:GE) announced today it is expanding its U.S. healthcare consulting business with the acquisition of Novia Strategies, a 22-year-old healthcare consulting firm founded and led by clinicians with deep experience helping organizations transform while delivering critical outcomes.  The acquisition helps GE Healthcare deliver on its commitment to be the... Read more

July 19, 2017 Acad, Gov/Utilities Clinical Research/Diagn. Microscopy PR/Corporate Product Launch

BD Receives FDA 510(k) Clearance for New Immunological Diagnostic System

FRANKLIN LAKES, N.J., July 19, 2017 /PRNewswire/ — BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the BD FACSLyric™ flow cytometer system, an easy-to-use in vitro diagnostic (IVD) system, for use with BD Multitest™ assays... Read more

July 19, 2017 Cell Analysis Tools Clinical Research/Diagn.

BD Receives FDA 510(k) Clearance for New Immunological Diagnostic System

BD FACSLyric™ Flow Cytometer System with BD Multitest™ Assays Offers Reliability and Consistency Jul 19, 2017 FRANKLIN LAKES, N.J., July 19, 2017 – BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the BD FACSLyric™... Read more

July 13, 2017 Clinical Research/Diagn.

BioLife Solutions CryoStor® Cell Freeze Media Embedded in Invossa™: First Approved Cell and Gene Therapy for Osteoarthritis

Korean Approval Received by Kolon Life Science, TissueGene’s Exclusive Licensee BOTHELL, Wash., July 13, 2017 /PRNewswire/ — BioLife Solutions, Inc. (NASDAQ: BLFS), the leading supplier of pre-formulated, clinical grade cell and tissue hypothermic storage and cryopreservation freeze media (“BioLife”), today announced that Kolon Life Science, TissueGene’s exclusive licensee for Asia, including Korea, has received marketing approval for Invossa-K Inj., the world’s first cell and... Read more

July 6, 2017 Clinical Research/Diagn. Life Science Tools

Promega Intends to Seek FDA Approval for Microsatellite Instability Assay to Assist in Strategic Cancer Decisions

MADISON, WI USA (July 6, 2017) Promega Corporation intends to seek US Food and Drug Administration approval and CE-IVD marking for a commercially available Microsatellite Instability (MSI) assay to assist oncologists and pathologists in determining colorectal cancer decisions. MSI status is a measure of mismatch-repair deficiency commonly found in solid tumors. In addition to the colorectal... Read more

July 4, 2017 Clinical Research/Diagn.

Roche launches the first fully automated CE marked HIV-1/HIV-2 qualitative diagnostic test on cobas® 6800/8800 Systems

July 4, 2017   Differentiates between HIV-1 and HIV-2 infections to confidently treat patients based on HIV subtype infection Significant reduction in time to detection is critical in curbing further disease transmission Access to testing in rural areas through validated dried blood spot (DBS) collection card Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the commercial... Read more

July 3, 2017 Clinical Research/Diagn. Life Science Tools

Roche expands cobas Liat PCR System menu with launch of cobas MRSA/SA test to target healthcare-associated infections

Basel, 03 July 2017 Roche expands cobas Liat PCR System menu with launch of cobas MRSA/SA test to target healthcare-associated infections With more than 150,000 affected patients per year, MRSA and SA are major sources of healthcare and community associated infections in Europe Fast detection reduces the risk of transmission within the hospital, but classical... Read more

June 29, 2017 Chromatography Clinical Research/Diagn. Mass Spectrometry

The New SCIEX Clinical AB SCIEX TRIPLE QUAD™ 4500MD LC-MS/MS System Obtains CFDA Approval as Medical Device for in vitro Diagnostic Use

The AB SCIEX TRIPLE QUAD™ 4500MD LC-MS/MS system has been approved by the China Food and Drug Administration (CFDA) and meets the market access requirements for medical device products. 1 June 29, 2017 Shanghai, China — SCIEX Diagnostics, the in vitro diagnostics division of SCIEX, a global leader in mass spectrometry in the life sciences industry, announced today that... Read more