Biotech's slow coup of the mobile industry never ceases to amaze me. In this latest piece of news, the addition of a simple (and cheap) ball lens to the iPhone camera creates a microscope strong enough to view details at the cellular level. It is being touted as the perfect device for roaming doctors or those in low-income areas for quick diagnosis of blood disease. With the advent of the iPhone 4S (latest version announced last Tuesday, to ship this Friday, Oct. 14th), the new 8-megapixel lens will make the iPhone an even better imaging because of the better resolution its pictures will have.
Of course, the FDA will require some oversight in this case. The mobile app guidance document (though still in draft form) states that any additions to the phone may be considered a medical device and will consequently be subject to oversight. As this "microscopic lens case" will be used in diagnosis, it is a pretty sure bet that the FDA will keep its collective eye on this one and will certainly expect some control over the case.
-RTK