Medtronic (NYSE:MDT) reportedly said this week that its years-long delay in releasing adverse event data for its controversial Infuse bone-growth protein was inadvertent. The Minneapolis Star Tribune last month reported that a 2-year Medtronic review of some 3,647 Infuse patients in 2008 turned up about 1,000 adverse events that weren’t reported to the FDA until 2013. That prompted Sens. Al Franken […]
A bipartisan duo in the U.S. Senate introduced a bill last week that aims to streamline the way the FDA reviews medical devices. Sens. Amy Klobuchar (D-Minn.) and Pat Roberts (R-Kan.) introduced S.2737, or “A bill to improve medical device innovation,” to the Upper Chamber’s Health, Education, Labor & Pensions committee March 17. Earlier this month the panel […]
U.S. Senators Chuck Grassley of Iowa and Elizabeth Warren of Massachusetts are pushing for more unique device identifier integration on medical claim forms from U.S. healthcare agencies, with a focus on the Centers for Medicare and Medicaid Services. CMS was called out for expressing views on the system that are contradictory to those from the Department of […]
A U.S. Senate panel yesterday advanced a bill that would create a fast-track program at the FDA for breakthrough medical devices. The Senate Health, Education, Labor & Pensions committee sent the bill, S. 1077 or “A bill to provide for expedited development of and priority review for breakthrough devices,” to the Senate floor. The bill, introduced last […]
Four U.S. Senators yesterday wrote the FTC urging a probe into possible illegal saline price inflation of 200-300% since a shortage of the fluid began in late 2013. The letter, sent to FTC chairwoman Edith Ramirez, was signed by Conn. dem senator Richard Blumenthal, Minn. dem Amy Klobuchar and Utah reps. Mike Lee and Orrin […]
A new U.S. bill introduced by 4 senators would allow Medicare patients to self-pay for medical devices not fully covered by Medicare without dealing with a series of administrative hurdles. The bill, titled the Accelerating Innovations in Medicine Act, was sponsored by Sens. Rob Portman (R-Ohio), Michael Bennet (D-Colo.), John Thune (R-S.D.), and Martin Heinrich […]
A new Senate bill introduced yesterday would create a fast-track program at the FDA for breakthrough medical devices
The bill, S. 1077 or " A bill to provide for expedited development of and priority review for breakthrough devices," was sponsored by Sen. Richard Burr (R-N.C.) and co-sponsored by Sens. Orrin Hatch (R-Utah) and Michael Bennet (D-Colo.).