U.S. Senators Patti Murray (D-Wash.) and Elizabeth Warren (D-Mass.) are challenging an FDA budget proposal that would ease the approval process for certain medical devices. In a June 24 letter to Acting Commissioner Dr. Ned Sharpless and Dr. Jeffrey Shuren, director of the Center for Devices and Radiological Health, Murray and Warren target the “progressive […]
Medtronic: Infuse data delay was inadvertent
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 […]
Senate bill would streamline FDA’s medical device reviews
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 […]
Senators Warren, Grassley want more from CMS on UDIs
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 […]
Senate panel advances FDA fast-track bill
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 […]
US Senators urge FTC to probe Baxter, Braun & Hospira saline prices
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 […]
Senate bill would allow Medicare patients to self-pay for med devices
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 […]
FDA panel on aneurysm devices | Regulatory news for the week of April 27, 2015
Burr introduces fast-track FDA bill
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.).
Analysis: Medtech gains on Wall Street and the Beltway with big GOP win
Bayh: Obama is open to repealing the medical device tax
Regardless of whether Republicans are able to re-take the U.S. Senate in the midterm elections, there’s a good chance the medical device tax will be repealed, according to former Sen. Evan Bayh.
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