Product Using Direct Data Entry Receives FDA Marketing Clearance

The FDA has cleared for marketing a medical cooling device from Lund, Sweden­based Dignitana. Digitana engaged Target Health as its CRO, using its web-based eSource-enable EDC system to collect direct data entry from patients. According to Target Health, this is the first product to be approved using in its pivotal trial, direct  data entry of patient data at the time of the clinic visit into an EDC system, with no  need for paper records.