FDA

About the Author: Bradley Merrill Thompson is a member of the firm at Epstein Becker & Green, P.

In the last quarter the FDA gave the nod to 10 digital health devices.

Malay Gandhi, best known as the former CEO of Rock Health, has joined Evidation Health as SVP of Business Operations.

Smart inhaler company Adherium announced last week that it has received 510(k) clearance for over-the-counter sales of its inhaler monitoring device for AstraZeneca’s Symbicort aerosol inhaler, called the SmartTouch for Symbicort.

Yesterday Dexcom got the nod from the FDA to market their Dexcom G6, an integrated continuous glucose monitoring system (iCGM), making it the first interoperable CGM to get the designation.

The healthcare innovation industry is a multifaceted ecosystem: From the energetic new startup developing a product and the venture firm backing it, to the FDA regulating the new invention, there are plenty of forces working in concert.

The FDA has launched a free mobile app version of its Drugs@FDA online database that offers consumers information on agency-approved drugs.

Opternative, a Chicago-based purveyor of online and mobile refractive eye exams, received a warning letter from the FDA last fall.

A recently released analysis report from the Deloitte Center for Government Insights that examines the US’s current and proposed software as a medical device (SaMD) regulatory landscape, and includes suggestions on how the FDA’s pre-certification pilot program and other initiatives could better serve this fast-moving industry.

Medtronic has finally received FDA clearance for Guardian Connect, its smartphone-connected standalone CGM for patients who use multiple daily injections (MDI) for their insulin.