EXTENSION Inc., a Fort Wayne, Ind.-based vendor of mobile clinical apps, has taken the unusual step of submitting a clinical alert application to the U.S. Food and Drug Administration for clearance—even though the FDA does not currently regulate the clinical mobile software market.
Todd Plesko, CEO at EXTENSION, says the decision to ask for Class III Medical Device clearance is due to his certainty that the FDA plans to regulate the market in the near future.
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