Category Archives: Medical Devices

Treating the Patient, Not the Symptoms – FDA and Digital Health

Posted on May 1, 2018 by Mark Senak

Last week Commissioner Scott Gottlieb delivered remarks at the Health Datapalooza, the meeting representing a nexus between innovation in digital health and the world of policy. He began his talk by saying that for most of the last century, medical … Continue reading →

Posted in FDA Image, FDA Policy, Medical Devices | 1 Comment

The Convergence of Digital Health, Devices and Pharma

Posted on November 15, 2017 by Mark Senak

There has been a huge push in policy circles to speed innovation in medicine which is manifest in several initiatives, including most notably the 21st Century Cures Act implementation. But it would be a mistake to assess the quickening pace … Continue reading →

Posted in Approval Announcements, Medical Apps, Medical Devices | Comments Off on The Convergence of Digital Health, Devices and Pharma

FDLI Conference on Advertisting and Promotion

Posted on October 3, 2012 by Mark Senak

The Food and Drug Law Institute held its annual conference on Advertising and Promotion for the Pharmaceutical, Medical Device, Biologic and Veterinary Medicine Industries in Washington, D.C. on October 1 and 2.  I was able to attend sporadically and participated … Continue reading →

Posted in FDA Policy, Medical Devices, New and Social Media | 1 Comment

Expanding World of Medical Apps – Quantity and Quality

Posted on June 25, 2012 by Mark Senak

This weekend the Washington Post carried an article that, among other things, focused on the explosion of apps available in healthcare. Entitled “Health-care Apps of Smartphones Pit FDA Against Tech Industry” the primary thrust of the article was as the … Continue reading →

Posted in Medical Apps, Medical Devices | 2 Comments