By: Scott Gottlieb, M.D. When people think about personalized medicine, they often think of genetic testing and sequencing of the human genome. But the concept of personalized medicine is much broader. It includes the re-imagination of healthcare delivery. It includes empowering consumers to take more control of their own healthcare information to make better informed […]
Patient Reps: Bringing the voice of patients to FDA
By: Jack Kalavritinos At FDA we never lose sight of the fact that the work we do in evaluating and approving new medical products is done to benefit patients. Increasingly, that means taking into account the views and expertise of patients and their caregivers, because they provide a unique voice and perspective and know best […]
Medtech stories we missed this week: July 28, 2017
From Accenture’s AI-powered app to help the visually impaired to Rayovac getting clearance from Health Canada, here are seven medtech stories we missed this week but still thought were worth mentioning. 1. Accenture touts AI-powered app for visually impaired Accenture announced in a July 28 press release that it has developed an artificial intelligence–powered way to […]
FDA sets inaugural meeting of first-ever Patient Engagement Advisory Committee
By: Kathryn O’Callaghan and Jeffrey Shuren, M.D., J.D. Imagine checking your blood sugar levels several times a day with a glucose meter to keep your diabetes under control. Or maybe you’ve had a hip joint replaced or a stent inserted in your coronary artery to treat a heart blockage. Maybe you participated in a clinical […]
Chinese regulators identify first round of medical device clinical trial inspections
By Stewart Eisenhart, Emergo Group Following its recent announcement of a new inspection program for medical device clinical trial sites, the China Food and Drug Administration (CFDA) has identified the first round of sites that will undergo such inspections. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog […]
FDA unveils new policy for accepting medical device consensus standards
By Stewart Eisenhart, Emergo Group US medical device regulators at the Food and Drug Administration have disclosed a new process for evaluating and accepting voluntary consensus standards. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of […]
Building a strong FDA workforce to bring scientific advances to patients
By: Scott Gottlieb, M.D. The key to FDA’s public health mission, and its ability to bring innovative new therapies to patients, is the technical, scientific, and clinical expertise of its people. As the products that we’re asked to review become more complex and specialized, so do the technical demands on our workforce. Our staff must […]
Medtech stories we missed this week: July 21, 2017
From Second Sight’s South Korean market entry to Sanuwave’s Indonesian distribution deal, here are medtech stories we missed this week but thought were still worth mentioning. 1. Second Sight enters South Korea market Second Sight announced in a July 5 press release that it has entered the market in South Korea with the implantation of two […]
Australian TGA to handle medical device advertising complaints
By Stewart Eisenhart, Emergo Group The Australian Therapeutic Goods Administration (TGA) plans to roll out “simplified and improved arrangements” for managing complaints regarding medical device and drug advertising. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect those […]
Medical device R&D investments expected to rise through 2018
By Stewart Eisenhart, Emergo Group An Emergo survey of medical device companies finds that a higher percentage of smaller firms plan to increase their research and design spending over the next year than mid- and large-sized firms. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are […]