Thanks for the ‘Ones’ and ‘Zeros,’ Dr. Gottlieb

Posted by Brian Chapman on March 15, 2019

I admit, the title of this post is an attempt at a ham-fisted connection between the FDA’s impressive, forward-looking digital strategy under Commissioner Scott Gottlieb (as he wraps up his post following his March 5th resignation) and an overall reckoning from his tenure. I also must admit that my assessment has some shortcomings: I watch the FDA from a distance, avoid the political elements and focus only on the medtech industry (drug prices, generic approvals and vaping notwithstanding). Although Jeffrey Shuren, the director of the Center for Devices and Radiological Health, and others at the FDA probably should share credit for many of the positive accomplishments in medtech, the tenure of a leader should be judged by the organization’s accomplishments during that time. As Gottlieb prepares to move on from his role in public service, I’d like to share a few thoughts on the agency’s recent impact on the medtech industry.


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How the FDA's New 510(k) Guidelines Could Help or Hurt Medtech

Posted by Sundeep Karnik on January 14, 2019

Matt Singer co-wrote this blog post with Sundeep Karnik.

Recently, the FDA announced new steps to modernize its 510(k) regulatory clearance pathway. This is the first major overhaul of a process that has been in place since 1976. The FDA intends to implement three major changes:


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Et Tu, FDA? Why Medtech Needs to Stop Feeling Betrayed by the FDA

Posted by Brian Chapman on October 31, 2018

For shame! How could the FDA approve a silly touch screen watch to do the job of serious cardiologists—and rush it through the approval process, too? How could a high-end stereo-equipment-maker suddenly become a supplier of medical devices? And then there’s the notion that this device could be fitted without the help of a qualified professional!


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The Apple Watch Wake-Up Call

Posted by Brian Chapman on September 20, 2018

By now, we’ve all heard the latest digital health news: Apple secured FDA clearance for its EKG app on the newest Apple Watch. The tech giants are coming! The end is near!


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Here Come the Patients: The Increasing Role of Patient Preferences in FDA Decision-Making

Posted by Tobi Laczkowski on April 12, 2017


Patient empowerment is manifesting itself in many forms across the healthcare landscape, and its influence on medtech approvals is growing.


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