Sen. Amy Klobuchar (D:Minn.) and Rep. Erik Paulsen (R:Minn.) urge the Food & Drug Administration to go easy on proposed changes to the 510(k) program.
A pair of Minnesota legislators are lobbying against changes the Food & Drug Administration proposes for its 510(k) clearance protocol the industry says will hurt innovation and the state’s economy.
U.S. Sen. Amy Klobuchar (D:Minn.) and Rep. Erik Paulsen (R:Minn.) sent a letter to FDA Commissioner Dr. Margaret Hamburg, warning that overzealous regulation would hurt start-ups struggling to raise venture capital in a weak economy.
Covidien’s 3-year study results showing positive outcomes for its Urgent PC Neuromodulation system in...
NEC Display Solutions wins 510(k) clearance for its 21-inch medical monitor systems.
J&J's former head of global cardiology makes the jump to CEO at Itamar Medical
Sunshine Heart raises $1.5 million of a hoped-for $25.5 million equity funding round.
J&J subsidiary Lifescan asks the courts to ban Shasta from using its logo, saying problems with...