regulatory approval

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 […]