[go37pi]

I'd think that the non-invasive restriction is most likely related to the FDA's distinction between significant risk devices and non significant risk devices. In addition to traditional study approvals(Independent Review Board etc.), significant risk devices require FDA approval to begin testing for effectiveness (IDE applications) and are fraught with risk.

I don't remember offhand if finger-stick blood glucose testing devices are termed significant risk devices or if they are given exemptions. If these devices are given exemptions, then this would likely be a good precedent to follow to execute lab on a chip type devices.

I agree that the lab on a chip analysis represents the most exciting part of the implementation, but I also think that it would be interesting to see what types of associations we can get with usual metrics such as pulse, blood pressure, etc. when the data is more easily obtained.

Further information on significant and non-significant risk devices is available on the FDA website: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidanc...