Tag Archives: medical devices

Questions About The FDA’s New Framework For Digital Health

Under a new administration, the FDA is experimenting with a new way to balance innovation and risk with emerging medical technologies.

August 16, 2017

21st Century Cures Act Lowers Confidence In FDA-Approved Drugs And Devices

While it is difficult to ignore the positive aspects of the 21st Century Cures Act, there is also legitimate cause for concern that the traditional regulatory standards we have come to rely on may be modified, with unknown long-term effects on the safety and efficacy of new drugs and devices.

February 14, 2017

Medical Technology: What Changing Venture Capital Investments Signal

The market for medical devices historically has been dominated by big-ticket “physician preference items.” Changes in physician payment and organization are reducing the demand for these cost-increasing innovations, and redirecting the flow of investment capital.

January 9, 2017

Time To Fix The Black Hole In Medicare Data

Medicare pays for nearly 500,000 hip and knee replacement surgeries every year, while at the same time 25,000 patients undergo procedures to remove and replace a previous artificial joint. Remarkably, and largely due to inadequate data collection, the program is unable to identify product...

June 29, 2016

Hearing Aids And The Sound Of Mobile Health Disruption

Health care incumbents are losing at the app game and it may be time to give more freedom to the forces of disruption. Recent developments in the markets for hearing aids suggest some answers and even a possible regulatory approach to the broader and burgeoning category of mobile health apps...

June 17, 2016

Health Policy Brief: Aligning FDA And CMS Review

A new policy brief from Health Affairs and the Robert Wood Johnson Foundation touches on recent initiatives to close gaps between the medical technology evaluation processes of the FDA and CMS.

August 28, 2015