Baucus Floats Idea Of Forcing Hospitals To Report Device Prices, Device Makers Protest

Baucus Floats Idea Of Forcing Hospitals To Report Device Prices, Device Makers Protest: "Senate Finance Committee chair Max Baucus (D-MT) has signaled he may push to mandate that hospitals report medical device prices to CMS in response to congressional investigators' discovery of major pricing disparities with implantable devices -- a reporting idea hospital officials tell Inside CMS should instead be directed at the medical device industry and the medical device industry rejects as unnecessary. "

Safety Advocates Unveil Device Safety Agenda, Ramp Up Lobbying

Safety Advocates Unveil Device Safety Agenda, Ramp Up Lobbying: "Consumer safety advocates are unveiling a broad medical device reform agenda as they increase lobbying efforts on Capitol Hill, with groups focusing on more rigorous approval for implantable devices, restrictions on using recalled predicates, increased requirements for post-market studies, implementation of the delayed unique identifier system and a national device registry, and greater scrutiny of direct-to-consumer medical device advertising."

CMS Considers New Strategies For Reviewing IDE Trials

CMS Considers New Strategies For Reviewing IDE Trials: "The agency is exploring ways to consolidate the reviews of category B investigational device exemption studies under a single Medicare administrative contractor (MAC), as opposed to the current practice of contractors making coverage determinations in each jurisdiction where the trial is being conducted."

Consumer group demands more med-tech oversight from MDUFMA III

Consumer group demands more med-tech oversight from MDUFMA III: "Patient advocacy group Consumer Union petitions the FDA to implement more stringent oversight for medical devices in the new medical device user fee agreements, to prevent the public from being used "as guinea pigs when it comes to something as important as a medical implant."

Pediatric Device Reauthorization Bill Mandates FDA Issue Withdrawn Reporting Rule

Pediatric Device Reauthorization Bill Mandates FDA Issue Withdrawn Reporting Rule: "A bipartisan duo of House lawmakers Wednesday (Feb. 8) introduced a bill that would require FDA finalize a pediatric medical device rule mandating device manufacturers include in applications potential pediatric populations that could benefit from the device, a requirement that the agency withdrew in 2010 after objections from industry. "

Stryker Seeks CEO After MacMillan Steps Down for Family Reasons - Businessweek

Stryker Seeks CEO After MacMillan Steps Down for Family Reasons - Businessweek: "Stryker Corp. Chief Executive Officer Stephen MacMillan led the company’s expansion efforts and helped the maker of artificial hips and knees navigate an industrywide probe before his resignation yesterday for family reasons."

NatJournal: Medical-Device Industry Doubles FDA Fees

NatJournal: Medical-Device Industry Doubles FDA Fees: "Medical-device companies have agreed to more than double the fees that industry pays the Food and Drug Administration to review new medical products."