Wednesday, February 18, 2009

Trekkie Alert: Medical Tricorders May Come Soon

Peter Pitts at Drugwonks shows that soon Star Trek medicine may come to all of us in the form of a medical tricorder.

In a post entitled 510(k) for a Tricorder, he writes:



Doctors could soon be using a Star Trek-style device the size of a BlackBerry to check patients' genetic suitability to different medicines. A prototype of the hand-held device is already being tested by British scientists, who say it could be on the market in two years. The SNP (pronounced snip) Doctor is the kind of gadget that might by have used by Dr Leonard McCoy in the original Star Trek TV series.
From a drop of saliva or cheek swab it can analyse DNA to tell if a patient has the right genetic fit for a particular drug.





For those of you who don't live and breathe the FDA approval process, 510(k) refers to the process of approving medical devices for use in the USA. According to the FDA in its Premarket Notification 510(k) webpage:





A 510(k) is a premarket submission made to FDA to demonstrate that the device to
be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR 807.92(a)(3)) that is not subject to PMA. Submitters must compare their device to one or more similar legally marketed devices and make and support their substantial equivalency claims. A legally marketed device, as described in 21 CFR 807.92(a)(3), is a device that was legally marketed prior to May 28, 1976 (preamendments device), for which a PMA is not required, or a device which has been reclassified from Class III to Class II or I, or a device which has been found SE through the 510(k) process. The legally marketed device(s) to which equivalence is drawn is commonly known as the "predicate." Although devices recently cleared under 510(k) are often selected as the predicate to which equivalence is claimed, any legally marketed device may be used as a predicate. Legally marketed also means that the predicate cannot be one that is in violation of the Act.


"Don't leave him in the hands of 20th Century Medicine." Dr. McCoy, Star Trek IV: The Voyage Home.


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