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  • FDA Grants Emergency Use Authorization for Siemens Zika Virus Detection Tech - top government contractors - best government contracting event
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    FDA Grants Emergency Use Authorization for Siemens Zika Virus Detection Tech

    The Food and Drug Administration has granted an emergency use authorization to a Siemens subsidiary for an assay kit built to detect the presence of the mosquito-borne Zika virus in patients. PCR Zika Virus assay VERSANT Zika RNA 1.0 Assay (kPCR) Kit. The FDA uses the EUA designation to clear unapproved medical products and unapproved uses of them in certain […] More

  • Salient CRGT Promotes John Edgar as SVP; Kevin Bahumian & Anuj Mathur to VP - top government contractors - best government contracting event
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    Salient CRGT Promotes John Edgar as SVP; Kevin Bahumian & Anuj Mathur to VP

    Salient CRGT has elevated John Edgar, former company vice president and chief strategist for information technology transformation, as a senior VP while Kevin Bahumian and Anuj Mathur have been promoted to the roles of vice president from their former directorial positions. The software development and technology services company said Thursday Edgar will continue to manage Salient’s innovation centers and provide leadership […] More

  • FDA Seeks Info on COTS Quality Management Software Sources - top government contractors - best government contracting event
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    FDA Seeks Info on COTS Quality Management Software Sources

    The Food and Drug Administration has sought information on potential industry sources that can provide a commercial off-the-shelf software platform designed to help FDA compile audits and assessments as well as detect and monitor preventive and corrective actions. FDA said in a FedBizOpps notice posted Friday the proposed Quality Management Information System should be designed to capture […] More

  • FDA OKs Emergency Use of Hologic's Zika Virus Diagnostic Tool - top government contractors - best government contracting event
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    FDA OKs Emergency Use of Hologic’s Zika Virus Diagnostic Tool

    Massachusetts-based medical technology developer Hologic has received emergency use authorization from the Food and Drug Administration for a device the company developed to help clinicians detect Zika virus infections. Hologic said Friday its Aptima molecular diagnostic assay is designed for qualitative detection of ribonucleic acid from the mosquito-borne virus in human blood samples. The assay is based on the company’s Panther system that works to […] More

  • CMS, FDA Vet Mark McClellan Joins American Well as Advisory Board Vice Chairman; Ido Schoenberg Comments - top government contractors - best government contracting event
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    CMS, FDA Vet Mark McClellan Joins American Well as Advisory Board Vice Chairman; Ido Schoenberg Comments

    Mark McClellan, director of the Health Policy Center at Duke University, has joined telehealth technology and services company American Well as vice chairman of the advisory board. McClellan previously served as director of the Health Care Innovation and Value initiatives at Brookings Institution and managed the Richard Merkin program on payment reform and clinical leadership, […] More

  • NIST, Stanford University Enter Partnership to Foster Biotech Measurement Infrastructure - top government contractors - best government contracting event
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    NIST, Stanford University Enter Partnership to Foster Biotech Measurement Infrastructure

    The National Institute of Standards and Technology will collaborate with Stanford University to develop measurement units for biotechnology products and services in sectors such as healthcare, energy and electronics. NIST said Friday the NIST-Stanford Joint Initiative for Metrology in Biology looks to engage academia, industry and government in the development of tools that would help establish units of measurement for […] More

  • HHS, FDA Vet Melissa Chapman Joins Triple-i as BD, Capture Unit VP - top government contractors - best government contracting event
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    HHS, FDA Vet Melissa Chapman Joins Triple-i as BD, Capture Unit VP

    Melissa Chapman, a former chief information officer and deputy assistant secretary from the Department of Health and Human Services, has joined Springfield, Virginia-based information technology services company Information Innovators Inc. as new vice president of the business development and capture unit. Chapman joined the company in May and has since led its HHS market growth strategy through subject matter and technical […] More

  • HumanTouch to Support CDC, FDA Through New Atlanta Office - top government contractors - best government contracting event
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    HumanTouch to Support CDC, FDA Through New Atlanta Office

    HumanTouch has established an office in Atlanta, Georgia to provide help desk and information technology support services to the Food and Drug Administration and the Centers for Disease Control and Prevention. The company said Monday it will support health IT operations of both the FDA and CDC from the company office as part of two federal contracts the company holds positions […] More

  • DoD Adopts Mediware-Built Blood Donation Mgmt Software - top government contractors - best government contracting event
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    DoD Adopts Mediware-Built Blood Donation Mgmt Software

    The Defense Department has installed a Mediware Information Systems-designed blood establishment computer software the military now uses at more than 20 treatment facilities worldwide. DoD will use Mediware’s LifeTrak to manage blood donations and handle tasks for functions in areas such as donor recruitment and management assistance, manufacturing, testing, labeling and blood product distribution, Mediware said Thursday. The Military Health System uses LifeTrak for MHS’ […] More

  • Commonwealth Informatics, FDA Forge Clinical Data Analytics Agreement; Geoffrey Gordon Comments - top government contractors - best government contracting event
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    Commonwealth Informatics, FDA Forge Clinical Data Analytics Agreement; Geoffrey Gordon Comments

    Commonwealth Informatics and the Food and Drug Administration have forged a two-year agreement to utilize the Commonwealth Clinical Data Analytics platform designed to help FDA assess drug safety data. The company will work under the research collaboration agreement to help FDA reviewers detect and investigate safety signals when new drug applications are being tested, Commonwealth […] More

  • FDA OKs Siemens Twin Robotic X-Ray System; Martin Silverman Comments - top government contractors - best government contracting event
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    FDA OKs Siemens Twin Robotic X-Ray System; Martin Silverman Comments

    Siemens‘ healthcare unit has received clearance from the Food and Drug Administration for the company’s twin robotic X-ray system. The Multitom Robotic Advanced X-ray platform is designed to generate three-dimensional images in various clinical examinations such as radiography, angiography, fluoroscopy and orthopedics, Siemens said Sunday. The imaging system has an adjustable table for patients and two robotic arms […] More

  • Salient CRGT to Operate Center for Veterinary Medicine Systems; Tom Ferrando Comments - top government contractors - best government contracting event
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    Salient CRGT to Operate Center for Veterinary Medicine Systems; Tom Ferrando Comments

    Salient CRGT Inc. has received a three-year, $15 million task order through its Guident subsidiary to operate and maintain the applications of the Food and Drug Administration’s Center for Veterinary Medicine. Salient CRGT will work with partners VersaTech and Appian to perform information technology support for CVM applications, systems and web services used by the […] More