Today's News
FDA Holds Up HeartWare LVAD Trial In Less Advanced Heart Failure Patients / Investigators for the REVIVE-IT pilot study received a second deficiency letter from FDA May 11; researchers say they continue to work with the agency to move forward on the 100-patient, randomized trial. / “The Gray Sheet”
Current Issue:
May 21, 2012
Regulatory
FDA Proposes Sliding-Scale Paradigm For Obesity Device Trials / Higher-risk devices, based on feasibility trial adverse event rates, would be matched to steeper effectiveness targets in pivotal studies for weight-loss under a plan outlined by the agency. / “The Gray Sheet” May 21, 2012
Latest Senate FDA Reform Bill Would Delay Guidance On Mobile Health Apps / The Senate user fee reauthorization and FDA reform bill, formally introduced May 15, includes several new provisions, including a moratorium on FDA issuing final guidance on mobile medical apps. The bill should see action on the Senate floor this week. / “The Gray Sheet” May 21, 2012
Not So Special? FDA Proposal Would Damage Streamlined 510(k) Submissions Program, Firms Say / Agency’s proposed “special 510(k)” reforms, outlined in a recent draft guidance, will make the streamlined submissions program a lot less streamlined, and also less accessible to many device modifications, companies say. / “The Gray Sheet” May 21, 2012
Public Hearing: IRS Tight-Lipped On Industry Device Tax Concerns / IRS remained mostly in listening mode during a recent public hearing on the impending device tax held at its headquarters in Washington, D.C. / “The Gray Sheet” May 21, 2012
Regulatory News In Brief / J&J queries FDA on the intricacies of device product codes and unique device identifiers. Biologics center strategic plan touches on diagnostics. / “The Gray Sheet” May 21, 2012
Advisory Panels
OraSure In-Home HIV Test’s Promise Outweighs Risks, Panel Concludes / FDA’s Blood Products Advisory Committee endorses OraSure’s OraQuick in-home HIV test in a unanimous 17-0 vote on May 15. If approved, OraQuick would be the first-ever over-the-counter test for HIV that can be performed entirely in the home by untrained users. / “The Gray Sheet” May 21, 2012
Reimbursement
New Coverage-With-Evidence-Development Guidance In The Works Following MedCAC Meeting / The Medicare Evidence Development & Coverage Advisory Committee was charged May 16 with helping CMS better define the evidence threshold under which the agency should or should not pursue a coverage- with-evidence-development policy. / “The Gray Sheet” May 21, 2012
New Products
New Products In Brief / Recent approvals and launches include St. Jude Medical’s EnligHTN renal denervation system for hypertension and Zeltiq Aesthetics’ expanded CoolSculpting clearance for fat reduction. / “The Gray Sheet” May 21, 2012
Mobile Health
FCC Chairman Sings MBAN Praises In Advance Of May 24 Spectrum Vote / Julius Genachowski, chairman of the Federal Communications Commission, met May 17 with officials from GE Healthcare, Philips Healthcare and George Washington University Hospital to highlight the benefits of medical body area networks in improving care and reducing costs. / “The Gray Sheet” May 21, 2012
Clinical Trials
FDA Holds Up HeartWare LVAD Trial In Less Advanced Heart Failure Patients / Investigators for the REVIVE-IT pilot study received a second deficiency letter from FDA May 11; researchers say they continue to work with the agency to move forward on the 100-patient, randomized trial. / “The Gray Sheet” May 21, 2012
Research In Brief / Details from St. Jude's FAME II study on fractional flow reserve technology. / “The Gray Sheet” May 21, 2012
Financings
Financings In Brief / Cancer Genetics plans initial public offering. Mitralign raises $35 million for valve repair device. / “The Gray Sheet” May 21, 2012
News in Brief
News In Brief / CryoLife buys Hemosphere. Medtronic Infuse case closed. / “The Gray Sheet” May 21, 2012
International
U.K. Health Dept. Recommends Stronger Adverse Event Reporting System In Wake Of Breast Implant Scandal / Internal review finds U.K. regulators were not at fault in the PIP breast implant scandal, but recommends improvements to adverse event reporting and analysis. / “The Gray Sheet” May 21, 2012
Recalls
FDA Recalls List – May 9, 2012 /
CLASS II
FastPlan Treatment Planning System
Manufacturer:
Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA. / “The Gray Sheet” May 21, 2012
Personalized Medicine
Couples Therapy: VC Discusses Challenges In Companion Diagnostic-Biopharma Relationships / Companion diagnostic firms facing skeptical partners in big pharma need to focus on ways of establishing the value of their test to payers and patients, Third Rock Ventures’ Mark Levin told the Personalized Medicine Coalition. / “The Gray Sheet” May 21, 2012
Compliance & Enforcement
FDA Warning Letters Released The Weeks Of May 1 Through May 15 / Recent warnings to medical device manufacturers. / “The Gray Sheet” May 21, 2012
Mergers & Acquisitions
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” May 21, 2012
Publishers Spotlight
"Medical Device Complaint Handling" Special Report /
Does your complaint management system provide value to your company? Does your system recognize requirements to report to regulatory agencies (such as FDA, the EU, and Health Canada) and help you make the reports on time? / “The Gray Sheet” May 21, 2012