Costs related to winning 510(k) clearance for a medical device that were directly related to satisfying Food & Drug Administration rules average $24 million, according to a Stanford University report.
More than three-quarters of the cost to bring a medical device from concept to the U.S. market is spent clearing regulatory hurdles, according to a Stanford University report.
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...