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Set Alert for Policy and Regulation United States

Medtech's Unfinished Business For Congress In 2018: What's Ahead

US Congress successfully pushed through a user-fee bill in 2017 to help smooth the regulatory path at FDA for medical devices and other products, but other efforts, including several industry priorities, remain undone. On top on the list, of course, is the effort to repeal the device excise tax. But legislation is also on the table to address diagnostics regulation, telehealth reimbursement, and medtech cybersecurity vulnerability, among other issues. Here is a look at the medtech landscape in Congress in 2018.

Policy Legislation United States

Latest From United States, Policy & Regulation

Military Products Will Get US FDA Fast-Track Review

FDA and the US Department of Defense launched program to prioritize development of medical products for use in the battlefield. The program implements recently enacted compromise legislation that resolved a turf battle between the two agencies.

Regulation FDA

US FDA Extends UDI Deadlines For Low-Risk Devices

The agency slowed down its effort to require the overwhelming majority of medical devices to adopt Unique Device Identifiers with a a new guidance that would in delay full implementation of the UDI system for lower-risk devices.

Regulation Medical Device

MRI And Cardiac-Rhythm Devices: A Match Made In Medicare

A proposed coverage policy from the US Centers of Medicare and Medicaid Services would not only cover magnetic resonance imaging for patients with an implanted cardiac rhythm management device with an FDA-approved indication for MRI-compatibility, but will also cover MRI in patients with devices without that FDA labeling in certain circumstances.

United States Clinical Trials

Digital Health, Diagnostic Focus Included In FDA Commissioner's 2018 Strategy

Starting out 2018, Scott Gottlieb issued a new directive to US FDA staff outlining his priorities and vision. Among the directives is to promote digital health and diagnostics by creating efficient pathways for new products in the areas and focusing on technology to help consumers better track their health.

Digital Health Regulation

Device Week, Jan. 12, 2018 – Tracking Unfinished Medtech Business In The US Congress

On this week’s podcast, Medtech Insight’s Sue Darcey and Shawn M. Schmitt discuss an intriguing analysis of legislation that could be completed in 2018 that will likely impact the medtech industry.

Legislation Policy

Imaging Tech Lobby Group Hires New Cybersecurity Chief

In a sign of the times, the Medical Imaging & Technology Alliance, a major medtech trade organization in Washington, DC, has established a new director position on cybersecurity and has hired someone to fill it. Zack Hornberger will lead MITA's efforts to develop positions on cybersecurity policy and standards.

Cybersecurity Policy
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