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 ... Read More »

The Food and Drug Administration has released guidance on low-risk devices intended to promote general wellness, including mobile health and fitness apps. Under the final guidance, which contains “non-binding” recommendations for the industry, the FDA indicated that it “does not intend to actively regulate low-risk technologies that are intended only ... Read More »