Sen. Franken, Hamburg discuss device industry's concerns

Sen. Al Franken (D-MN) shared the medical device industry's concerns with regulators this week. He met with FDA Commissioner Margaret Hamburg as federal regulators are considering more than 70 changes to the 510(k) pre-market review process for low- and moderate-risk devices. Devicemakers say some changes are needed to simplify the process, but they're worried about the FDA's proposals to strengthen an expedited review process that they say has a strong safety record. "During our meeting on Thursday, the FDA Commissioner committed to working with me, as a member of the Senate committee that oversees the FDA, to address the concerns of Minnesota's medical device community," Franken said in a statement. Article | Story

Suggested Articles

The ADDF announced its second round of research awards, with a total of $6 million in new funding for diagnostic tests.

Takeda teamed up with Enzyre to develop an at-home diagnostic device that will help people with hemophilia determine their own coagulation status.

Foundation Medicine received a diagnostic approval from the FDA for selecting HR+/HER2- breast cancer patients for treatment with Novartis' Piqray.