FDA 510k

By Jonah Comstock 01:28 pm January 19, 2017
Updated with statement from Eli Lilly Indianapolis-based pharma company Eli Lilly recently recieved FDA 510K clearance for a new mobile app called Go Dose, a diabetes management and insulin dosing app for users of Humalog, Lilly's rapid-acting insulin. The clearance is for prescription use, but includes two versions of the app: Go Dose, for patients, and Go Dose Pro, for healthcare providers. "...
By Jonah Comstock 04:45 pm December 5, 2016
New York City-based Nanowear has received FDA clearance for SimpliECG, a "remote cardiac-monitoring undergarment". This is the first clearance for the company, which has been in talks with the FDA since 2015, according to a press release.  "This is a big milestone for our young company," Cofounder and CEO Venk Varadan said in a statement. "The FDA's decision not only positions us for commercial...