IVDs

New medical device regulations: The view from Europe

The increased globalization of the medical device landscape was a recurring theme as the industry gathered in Philadelphia for the MedTech Conference this fall. Sessions looked at recent regulatory and business developments in several key markets including Brazil, China, India and the U.S. Here is a look at one important panel discussion that took place […]

Nanotech medical device makers seek guidance in uncertain regulatory environment

There is little in the way of regulatory harmonization regarding nanotechnology regulation at this point, which leaves makers of devices and diagnostics with a complicated path to market. Some jurisdictions are farther along than others, but to date, none of them have covered as much ground as the U.S. Food and Drug Administration (FDA).   […]

Global issues stir debate at the 2018 MedTech Conference

News from the global stage resonated throughout the MedTech Conference as the industry gathered in Philadelphia for AdvaMed’s annual meeting.  Among the liveliest sessions were those focused on the future of the clinical trials landscape in the U.K. as a result of Brexit, the impact of trade wars on the industry, and Jeff Shuren, the […]

Med-techs extend borders seeking new opportunities

Medical device companies, eager to drive growth, are now increasingly seeking new opportunities – and approvals from regulators – throughout the world. Three recent examples of companies extending their reach across borders include: U.S.-based Abiomed garnering approval in India for three heart pumps; I. Ceram, a French company, achieving CE mark certification in Europe for […]

Global push in med-tech innovation prompts regulatory reviews and upgrades

In country after country, regulatory review and change in the med-tech industry have become a constant. Authorities are “advancing with the changing health care landscape,” as one industry representative put it, striking an upbeat note on recent regulatory updates around the world. In China, authorities seek to streamline reviews and approvals to drive innovation and […]