Evaluation of Medical Devices and Equipment
Members of our research team in clinical and biomedical engineering review the design
and application of medical devices and equipment for efficacy and safety. Items
must be approved or cleared by the U.S. Food and Drug Administration (FDA) as a Class
I, II or III device, accompanied with proper documentation and contract for evaluation.
Currently, we are evaluating the FDA device class 2 Sensokinetogram (SKG), a registered
product of Red Oak Instruments, LLC, for rapid, noninvasive screening of mild traumatic
brain injury (mTBI) or concussion for military and sports medicine applications.
The project is intended to improve triage and the earliest detection of mTBI in
the military and civilian theaters, such as battlefields and emergency medicine.
Another medical device that is under evaluation for patient safety is the Yeescope™,
a fully disposable, rigid laryngoscope (FDA device class 1). Disposal laryngoscopes,
widely used outside the U.S., may significantly reduce and prevent cross-contamination
and nosocomial infection among patients during surgery.
Both devices are registered with and cleared by the U.S. FDA for domestic market
and application. For more information about evaluation of medical devices and our
IRB process, please contact us.
