fulzy, Need for FDA clearance. fulzy, FDA clearance is to prove it meets certain stardard as to accuracy and reliabilty in gathering the specific iformation need for it to be classified as a diagnostic tool. In other words the devises you buy without FDA clearance are not expected to have this level of accuracy. A doctor cannot depend on them to give a diagnosis. But the most important thing about the FDA clearance is that this PEN now be prescribed by your doctor as part of homecare solution and extended care and should then be able to claim it under your medical insurance! If you read the GEMS presentation on the Cardiocomm site, GEMS softaware interpratation is covered for Physicians to expense, when this pen is out the Physicians will be able to expense the cost of interprating its data as well so it has healthcare money attached to it and that the main point. It will be accepted in the scope of practice. You cannot do that with the toys you buy at sportsmart.