From the Editor: U.S. Tariffs Cast Shadow Over Promising Growth of Pulsed Field Ablation Devices

Tariff uncertainty adds another layer of complexity to an already fragmented global regulatory environment. With PFA currently approved in only a handful of markets, the U.S. remains critical to commercial viability. Read on to learn more about what Sherrie Trigg, Editor and Director of Medical Content, has to say about the matter.

U.S. Tariffs: Implications and Strategies for Medtech Manufacturers

In a dramatic shift that could reshape the medical device industry, the U.S. government’s sweeping tariff hikes — particularly a 125 percent levy on Chinese goods — have...

Regulatory

What government group was formed to study medical devices and recommend legislation, ultimately leading to the 1976 Medical Device Amendments?

The Politics of Health: How Global Elections Will Impact on Life Sciences

The global landscape for medical technology, biotechnology, and life sciences is on the cusp of seismic change.

Ensuring Regulatory Compliance by Digitizing Change Control in Life Sciences Product Development

Medical device manufacturers face constant changes coming from both internal and external sources.

The ‘Hidden’ Tax on Medical Device Start-Up Funding

Starting on Dec. 31, 2012, the Patient Protection and Affordable Care Act’s (ACA’s) Medical Device Excise Tax began to be applied to the sales of all taxable medical devices in the US....