Zoll LifeVest is a wearable cardioverter defibrillator to monitor and treat dangerous abnormally fast heart rhythms. These abnormal rhythms can lead to a complete absence of heartbeat and death if not treated. Thus the LifeVest treats abnormal rhythms by applying a high energy shock similar to that of a traditional defibrillator.

What FDA class do you think this wearable cardioverter belongs in? Why?

What are some of the challenges Zoll Lifecor Corporation might have faced trying to get this device approved?

In class, we learned about how the market plays a big role for projects to go on the production line. Do you think this LifeVest is considered a marketable device that can be profitable for companies? (Hint: You can look into if there are any competitors)

If the inventors of LifeVest were to develop a mobile application that showed the user his or her heart rate only when the vest is worn, would this app be considered a mobile medical application? Why or Why not? (See the previous post about mobile medical application and reference describing mobile medical application for help)

Reference:
LifeVest Wearable Cardioverter Defibrillator: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm458494.htm

Mobile Medical Application:
http://www.fda.gov/downloads/MedicalDevices/…/UCM263366.pdf
http://www.fda.gov/MedicalDevices/DigitalHealth/MobileMedicalApplications/ucm255978.htm