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CMS’s final rule updating and revising the end-stage renal disease prospective payment system for 2015 nudges up the ESRD PPS base rate to $239.43, from the base rate of $239.02 in 2014. Read More
For the first time, devicemakers will have to report financial payments to continuing medical education programs (CME) under the Physician Payments Sunshine Act. Read More
Cancer drug developer Southern Research Institute and the University of Alabama at Birmingham have formed a strategic partnership known as the Alliance for Innovative Medical Technology (AIMTech) to develop new medical devices, the two groups said Tuesday. Read More
FDA regulations have gotten more restrictive and lengthy, with new data showing regulatory restrictions increased by a double-digit percent from 2000 to 2012. Read More
The FDA is seeking a court order to force a retired dentist in South Dakota to pull the laser devices he manufacturers from the market, but the defendant maintains he has the right to sell the devices through a private membership association. Read More
Stryker Orthopaedics has agreed to pay more than a billion dollars to settle class action suits filed against the company by patients who say they were injured by Stryker metal-on-metal hips. Read More
The FDA is seeking input on its efforts to facilitate patient participation in the regulatory approval process and on ways to assess those patient engagement activities. Read More
With FDA already raising concerns about cybersecurity vulnerability in medical devices, CMS may be the next agency to jump in with an HHS audit planned for next year. Read More
As Republicans prepare to take over the Senate, hope is building among devicemakers that the political shift may signal the end of the medical device excise tax, despite a new report indicating the tax would have a minimal effect on production and employment. Read More
Consolidation of the orthopedics devices space continued Oct. 27 as Wright Medical announced plans to merge with Tornier. The all-stock transaction has a combined value of approximately $3.3 billion. Read More
The Australia government plans to fast-track approvals of promising new medical technologies and conduct joint reviews with trusted foreign regulators as part of a broad effort to streamline the country’s device approval process. Read More
The Department of Justice said Wednesday that Biomet and its EBI subsidiary will pay the U.S. government more than $6 million to settle False Claims Act allegations. Read More