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Medical Design Excellence Awards 2018 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.

  • Alinity s
    Alinity s Series blood and plasma screening instrument improves blood and plasma services' efficiency in testing donations for infectious diseases like HIV and viral hepatitis. The Alinity s Series improves the screening process by increasing the loading capacity of test samples and automating historically manual processes.
    Manufacturer: Abbott Laboratories

    Abbott Laboratories
  • APAS Independence
    The APAS Independence is a standalone automated culture plate reading instrument that consistently screens and sorts 200 Petri dishes per hour. The triage system identifies negative plates and removes them from the workflow, allowing microbiologists to focus their expertise on the significant plates to accelerate reporting of patient results.
    Manufacturer: Clever Culture Systems 
    Supply and Design Credits: Planet Innovation, LBT Innovations, Hettich Holding Beteiligungs- und Verwaltungs-GmbH

    Planet Innovation
  • Panther Fusion System
    The Panther Fusion module is an in-lab upgrade to the Panther instrument. This full random-access system consolidates testing with a growing menu of respiratory, virology, women’s health, and sexually transmitted infection assays on a single instrument. The Panther Fusion system also features multiple amplification technologies, including polymerase chain reaction capability and transcription-mediated amplification technology.
    Manufacturer: Hologic Inc.
    Supply and Design Credits: DDstudio

    SEEKER is a high-throughput, laboratory-based instrument for newborn screening of lysosomal storage disorders. It uses fluorimetry to measure enzymatic activity related to four lysosomal storage disorders (Pompe, Fabry, Gaucher, and mucopolysaccharidosis type I) from newborn dried blood spot specimens routinely collected as part of state newborn screening programs.
    Manufacturers: Baebies Inc.
    Supply and Design Credits: Forma Life Science 

    Baebies Inc.
  • Sofia 2
    Sofia 2 is a benchtop analyzer that uses advanced fluorescence detection to rapidly test for diseases such as influenza, streptococcus and respiratory syncytial virus. Its interface and step-by-step on-screen guidance enables diagnostic testing by point-of-care professionals.
    Manufacturer: Quidel Corporation 
    Supply and Design Credits: Planet Innovation

    Planet Innovation
  • STERRAD VELOCITY Biological Indicator System
    The STERRAD VELOCITY Biological Indicator System is a hydrogen peroxide biological indicator that confirms proper sterilization of reprocessed surgical instruments within 30 minutes. The STERRAD VELOCITY Reader integrates with STERRAD sterilizers and uses optical measurement technology. It includes automated record keeping, compliance checks, and on-screen instructions. 
    Manufacturer: Advanced Sterilization Products (ASP), part of Johnson & Johnson Medical Devices Companies 
    Supply and Design Credits: Worrell

    Johnson & Johnson Medical Devices Companies
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