Digital health has gone global. On both sides of the Atlantic, healthcare stakeholders are evaluating these new tools, while innovators are navigating the pathways to implementation. It’s clear that while the North American markets and the European markets each have their own challenges, the industries also share plenty of universal opportunities and obstacles.
This week at the European...
About the Author: Bradley Merrill Thompson is a member of the firm at Epstein Becker & Green, P.C. There, he counsels medical device, drug, and combination product companies on a wide range of FDA regulatory, reimbursement and clinical trial issues. The opinions in this piece are Thompson's and don't necessarily reflect the opinions of MobiHealthNews or HIMSS.
Let’s say I could show you,...
US senators Elizabeth Warren (D-Mass.), Patty Murray (D-Wash.) and Tina Smith (D-Minn.) have penned another letter to the FDA expressing concern over the agency’s PreCert program.
In it, the senators acknowledge the opportunities for digital health, but also question the proposed regulation's ability to ensure safety of the products. The 10-page letter asks 18 pointed questions about the program...
A little over six months after the FDA moved its PreCert pilot along to the Test Plan phase, the agency released its Mid-Year Update on the program. At this stage, the original nine FDA PreCert pilot companies are now in the midst of test-driving the new Working Model. This means companies seeking to approve new products will go through the new PreCert pathway and the traditional review process...
