More Case Studies

ATTUNE

ensoetm Esophageal Cooling Device

Attune’s esophageal cooling device is a paradigm-shifting technology platform for cooling or warming patients. Utilizing a single-use, fully-enclosed triple lumen system, the device is inserted into the esophagus to modulate and control patient temperature in the operating room, recovery room, emergency room or intensive care unit.

Attune’s revolutionary new technology is now approved for use and helping save lives in the United States, Europe, Canada and Australia. 

WE DELIVERED

  • Product Requirements

  • Concept design and modeling

  • Product design and development

  • Verification and validation planning

  • Verification testing

  • Risk and hazard analysis

  • Test fixture design and testing

  • Comparative research and testing

  • Prototype

  • Manufacturing and sourcing support

  • ISO 13485 quality system scale up and support

  • Design history file development

  • CE Technical file development

  • 510K /de novo authoring /submission support

  • Grant authoring and submission support

  • Clinical trial support

 
Ensoetm esophageal cooling device