FDA
Cambridge, Massachusetts-based sensor maker MC10, known for its flexible and stretchable electronics, has received its first FDA 510(k) clearance for the BioStamp nPoint system.
At AcademyHealth’s 2018 Health Datapalooza on Thursday, the US Food and Drug Administration offered a vote of confidence for artificial intelligence in healthcare, promising more refined strategies for regulation, touting its tech incubator for AI innovation, and announcing a new machine learning partnership with Harvard.
This morning, the FDA published its 17-page first draft of a working model for its pre-certification program for software as a medical device (SaMD).
Digital health appears to be making its way onto the national stage.
The FDA has granted diagnostics company IDx’s De Novo request to market its AI-based software system for the autonomous detection of diabetic retinopathy in adults who have diabetes, called IDx-DR.
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.