April 17, 2019 Boston and Coloplast sink on mesh mess Transvaginal mesh implants are banned in the US, but remain a possibility in Europe.
December 11, 2018 The FDA’s proposed changes to device regulation are thin on detail The FDA has made a lot of noise about its plans to make medical devices safer. But these plans are somewhat amorphous; any meaningful steps would likely require congressional approval, and could thus take years.
November 06, 2017 Luck, strategy and FDA device approvals Experience and high staff levels help companies negotiate FDA approval – but luck plays a part.