Today's News
Agilent Builds Cancer Diagnostics Biz Via Dako Acquisition For $2.2 Billion / Research and testing product maker Agilent gains Dako’s c-Kit pharmDx and HER2 FISH pharmDx assays, among other cancer diagnostics, in the firm’s largest acquisition to date. / “The Gray Sheet”
Current Issue:
May 14, 2012
Regulatory
Device Firms Seek More Exemptions, Pricing Flexibility For Oncoming Excise Tax / Written comments were due May 7 on the Internal Revenue Service’s proposed regulation to implement a 2.3% excise tax on device sales in the lead-up to a May 16 public hearing. / “The Gray Sheet” May 14, 2012
FDA Will Not Broadly Release Report Criticizing EU Oversight / The agency decided not to widely disseminate a report examining 12 high-risk devices that were approved in Europe, but were later found to be dangerous or ineffective. / “The Gray Sheet” May 14, 2012
Fireworks Kept At Bay As Congress Pushes To Enact FDA Reforms By July 4 / Bipartisan FDA user fee reauthorization and reform legislation sailed unanimously through the House Energy and Commerce Committee May 10, with many similarities to a Senate version that has also passed out of committee. / “The Gray Sheet” May 14, 2012
House Moves Closer To Senate On FDA Bill / The chart compares provisions in the latest available versions of House and Senate FDA user fee reauthorization and reform bills. / “The Gray Sheet” May 14, 2012
Regulatory News In Brief / Regulatory updates from FDA and the White House. / “The Gray Sheet” May 14, 2012
Reimbursement
DME Suppliers Await CBO Score On Competitive Bidding Alternative / Durable medical equipment supplier groups pressed their “Market Pricing Program” during a May 9 House subcommittee hearing as an alternative to the Medicare competitive bidding program. The Congressional Budget Office is currently analyzing the proposal. / “The Gray Sheet” May 14, 2012
Obesity Device Makers Debate Merits Of CMS Gastric Sleeve Coverage Proposal / Allergan and Johnson & Johnson have differing responses to the Medicare agency’s proposal to require clinical trial participation in return for coverage of a laparoscopic sleeve gastrectomy procedure to treat obesity. / “The Gray Sheet” May 14, 2012
New Products
FDA’s April 2012 Clearances Of 510(k)s / Agency signs off on 252 devices via 510(k) during the month. / “The Gray Sheet” May 14, 2012
New Products In Brief / Recent product approvals and launches include St. Jude’s Assura and Ellipse ICDs, Boston Scientific’s Ingenio pacemakers and Medtronic’s Valiant Captivia thoracic stent graft system. / “The Gray Sheet” May 14, 2012
People
People In Brief / The latest moves by movers and shakers in the medical device and diagnostics industries / “The Gray Sheet” May 14, 2012
Clinical Trials
Research In Brief / Data updates from HRS, SCAI meetings, and more. / “The Gray Sheet” May 14, 2012
News in Brief
News In Brief / Smith & Nephew launches orthobiologics spinout. CMS proposes CED for wound care gel. / “The Gray Sheet” May 14, 2012
Recalls
FDA Recalls List – May 2, 2012 / Agency’s enforcement report includes 22 device recalls. / “The Gray Sheet” May 14, 2012
Comparative Effectiveness
Patients Could Play A Role In PCORI Research Application Reviews – Exec Director Selby / The notion of patient engagement in the research process could extend so far as to include reviewing applications submitted to the Patient-Centered Outcomes Research Institute, Executive Director Joe Selby says. / “The Gray Sheet” May 14, 2012
Digital Health
Digital Health In Brief / FCC sets MBAN discussion date. CMMI awards telemedicine projects. / “The Gray Sheet” May 14, 2012
Government, Industry Seek To Stimulate Telemedicine Growth / American Telemedicine Association annual meeting April 29-May 1 in San Jose, Calif., hosted about 4,600 attendees. / “The Gray Sheet” May 14, 2012
Publishers Spotlight
Webinar: Metrics for an FDA-Compliant Quality System: CAPA, Complaints, Supply Chain, Design and Validation /
Nonconforming products, CAPA systems, complaint systems, MDR systems, training systems, design systems, and risk systems: every business has its own set of metrics. During this special extended length webinar, James Eric Miller, Senior Quality Analyst in Roche's Diagnostics Division, will detail exactly which quality metrics can be used effectively and when they can be used and how-to monitor your quality systems. / “The Gray Sheet” May 14, 2012