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Medical Design Excellence Awards 2019 Finalists: Testing and Diagnostic Products and Systems

The following are the finalists for the Testing and Diagnostic Products and Systems category.

  • The Testing and Diagnostic Products and Systems category includes products that fall into FDA's group of chemistry, hematology, immunology, microbiology, pathology, and toxicology products. Click next to see the finalists.

  • Atellica Solution Immunoassay & Clinical Chemistry Analyzers 
    Atellica Solution is a multi analyzer system for in vitro diagnostic testing of clinical specimens. It offers unprecedented flexibility with over 300 configurations. Components can be arranged to create standalone or multi analyzer systems connected by the integral Magline sample transport. 
    Manufacturer: Siemens Healthcare Diagnostics, Inc.

    Siemens Healthcare Diagnostics, Inc.
  • Ceribell Rapid Response EEG 
    Ceribell significantly reduces the amount of time to get EEG for patients with suspicion of seizure because it does not require an EEG technician to apply and can immediately triage patients with the proprietary Brain Stethoscope algorithm instead of having to wait as much as hours for a Neurologist to read the EEG
    Manufacturer: Ceribell Inc.
    Supply and Design Credits: Whipsaw Inc.

    Ceribell, Inc.
  • The Dexcom G6 Continuous Glucose Monitoring System
    The Dexcom G6 Continuous Glucose Monitoring System (Dexcom G6 System) is a real time, continuous glucose monitoring device indicated for the management of diabetes. It is intended to replace fingerstick blood glucose testing for diabetes treatment decisions.
    Manufacturer: Dexcom

    Dexcom
  • PIVO needle-less blood draw 
    PIVO is an FDA-cleared needle-free vascular access device that temporarily repurposes an indwelling PIV line to extract a lab quality blood sample. It aims to reduce the anxiety of traditional blood draws for patients, to enable a safer practice for caregivers, and to improve efficiency for health systems.
    Manufacturer: Velano Vascular
     

    Velano Vascular
  • VENTANA DP 200 slide scanner
    The VENTANA DP 200 slide scanner is a digital pathology scanner for microscope slides. It is a computer and scanner based device that has the capability to scan, digitize, compress, store, retrieve, and view digitized images of slide specimens.
    Manufacturer: Roche Tissue Diagnostics
     

     

    Roche Diagnostics
  • VIP2000 Processor
    The VIP2000 processes slides using pre-programmed Vysis protocols for fluorescence in situ hybridization (FISH) for applications such as paraffin removal and the specimen pretreatment protocols for the Vysis UroVysion Bladder Cancer Kit and Vysis ALK Break Apart FISH Probe Kit. It is designed to provide faster test turnaround, to avoid delayed results and potential mistreatment.
    Manufacturer: Abbott Laboratories

    Abbott Laboratories
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