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Technology & Devices

OPKO Health Receives FDA Approval for the Point-of-Care Sangia PSA Test with the Claros 1 Analyzer

MIAMI, Feb. 01, 2019 (GLOBE NEWSWIRE) — OPKO Health, Inc. (NASDAQ: OPK) today announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s point-of-care Sangia Total Prostate Specific Antigen (PSA) Test using the Claros 1 Analyzer.  The product is indicated to quantitatively measure total PSA in whole blood from a …

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Centogene Develops New Validation Framework to Optimize Specificity and Sensitivity in Whole Exome Sequencing-Based Diagnostics

ROSTOCK, Germany–(BUSINESS WIRE)–CENTOGENE, a rare disease company committed to improving the lives of rare disease patients by providing solutions that accelerate the development of drugs, has published the development of a rationale framework to optimize sensitivity and specificity in whole exome sequencing (WES)-based diagnostics of a clinically heterogeneous patient population …

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Horizon Discovery and Rutgers University Form Exclusive Partnership to Develop Next Generation Novel Gene Editing Technology

CAMBRIDGE, England–(BUSINESS WIRE)–Horizon Discovery Group plc (LSE: HZD) (“Horizon” or “the Group”), a global leader in gene editing and gene modulation technologies, today announces that it has entered into an exclusive strategic partnership with Rutgers, The State University of New Jersey (US), to develop and commercialise a novel gene editing …

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CRISPR Therapeutics and ProBioGen Enter Collaboration and License Agreement to Develop Novel In Vivo Delivery Technologies

CAMBRIDGE, Mass. and BOSTON and BERLIN, Jan. 22, 2019 (GLOBE NEWSWIRE) — CRISPR Therapeutics (NASDAQ:CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, and ProBioGen, a premier German service and technology provider, today announced a multi-year research collaboration focused on the development of novel in vivo delivery modalities for …

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Obsidian Therapeutics and Celgene Collaborate to Develop Novel Cell Therapies that Utilize Obsidian’s Destabilizing Domain Technology

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Obsidian Therapeutics, a biotechnology company developing cell therapies with pharmacologic operating systems, today announced a strategic collaboration with Celgene Corporation (NASDAQ: CELG) for the discovery and development of novel, regulated cell therapies that utilize Obsidian’s Destabilizing Domain (DD) technology. Specifically, the collaboration is based on Obsidian’s DD technology for …

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Abbott to Acquire Mitral Valve Device Maker Cephea Valve Technologies

ABBOTT PARK, Ill., Jan. 16, 2019 /PRNewswire/ — Abbott (NYSE: ABT) announced today that it has exercised its option to purchase Cephea Valve Technologies, Inc., a privately held medical device company developing a less-invasive heart valve replacement technology for people with mitral valve disease. Financial terms were not disclosed. Abbott provided capital and secured …

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ZappRx and Bayer Partner to Improve Access to Specialty Medications

BOSTON–(BUSINESS WIRE)–ZappRx, a digital health company that streamlines the complex processes associated with prescribing specialty medications, announced an agreement with Bayer to provide a more efficient approach to the accessing of specialty medications and associated support programs. ZappRx will support patients living with two specific types of Pulmonary Hypertension (PH) and patients …

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FDA Approves World’s First Device for Treatment of Premature Babies and Newborns with an Opening in their Hearts

ABBOTT PARK, Ill., Jan. 14, 2019 /PRNewswire/ — Abbott (NYSE: ABT) today announced the U.S. Food and Drug Administration (FDA) approved the Amplatzer Piccolo™ Occluder, the world’s first medical device that can be implanted in the tiniest babies (weighing as little as two pounds) using a minimally invasive procedure to treat patent ductus arteriosus, …

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ArcherDX’s Companion Diagnostic Assay for both Liquid Biopsy and Tissue Specimens Granted Breakthrough Device Designation by the FDA

BOULDER, CO-ArcherDX, Inc., a molecular technology company dedicated to developing breakthrough solutions that advance the application of personalized genomic medicine, today announced that the U.S. Food and Drug Administration (FDA) granted a Breakthrough Device designation (formerly Expedited Access Pathway program) for ArcherDx’s companion diagnostic assay application. The FDA’s Breakthrough Device …

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Pfizer Collaborates with CytoReason To Utilize CytoReason’s Machine Learning Model of the Immune System for Drug Discovery

TEL AVIV, Israel–(BUSINESS WIRE)–CytoReason, a leader in machine learning for drug discovery and development, announced today that it has entered into a collaboration agreement with Pfizer Inc. (NYSE:PFE) that will leverage CytoReason’s cell-centered models of the immune system. CytoReason will receive from Pfizer payments potentially equaling up to low double …

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