“The Gray Sheet” from Elsevier Business Intelligence

FDA User Fee Reauthorization Charges Along With Senate Passage

rebecca.kern@elsevier.com — Mon, 28 May 2012 00:03:00 -0400

FDA user fee and reform bill sails through Senate on 96-1 vote. House plans to take up its similar legislation this week.

Hacking Of Wireless Devices Poses Growing Threat, Warns Homeland Security Report

m.hogan@elsevier.com — Mon, 28 May 2012 00:02:00 -0400

Department of Homeland Security bulletin details the risks of "malicious intrusion" into wireless health care networks and connected medical devices.

FDA Takes Initial Steps To Quantify Patient Opinion

d.tahir@elsevier.com — Mon, 28 May 2012 00:01:00 -0400

CDRH survey to quantify patients’ risk tolerance for obesity device therapies will begin soon, but some physicians and patient advocates are urging caution in applying the data.

FDA Recalls List – May 16, 2012

Mon, 28 May 2012 00:00:00 -0400

Recently reported recalls of medical devices.

Regulatory News In Brief

rebecca.kern@elsevier.com — Mon, 28 May 2012 00:00:00 -0400

FDA announces meetings on risk communication and imported products. U.S. and Mexico agree on communication guidelines.

Medical Body Area Networks Get Go-Ahead From FCC

m.hogan@elsevier.com — Mon, 28 May 2012 00:00:00 -0400

The Federal Communications Commission voted to approve MBAN spectrum May 24, and is now seeking public comments on how to designate an MBAN coordinator.

FDA Employee Assessments Don’t Always Include User Fee Performance Goals

Mon, 28 May 2012 00:00:00 -0400

Agency’s device center holds many reviewers to user fee pre-market time goals as part of employee performance reviews, but the goals are not explicit components of the CDRH director’s performance plan, an inverse approach to that of FDA’s drug center, according to the Government Accountability Office.

Medtronic Partners With Payers To Prove Economic Worth

d.filmore@elsevier.com — Mon, 28 May 2012 00:00:00 -0400

Recently inked partnerships with Aetna and a regional Italian government are focused on improving the economic data that Medtronic has at its disposal in support of its devices.

The 12%: Diagnostics “Quick Reviews” Make A Mark, FDA Official Says

d.filmore@elsevier.com — Mon, 28 May 2012 00:00:00 -0400

The first month of the diagnostics office’s “triage” pilot program has led to quicker reviews for some 510(k)s, an agency official reports. To qualify for the program's quick-review pathway, a submission must be of high quality and free of certain time-consuming complexities.

Research Industry Urges More Leeway For Disclosures In Sunshine Regs

l.radick@elsevier.com — Mon, 28 May 2012 00:00:00 -0400

The Association of Clinical Research Organizations is pressing CMS to minimize the negative impacts on researchers when it finalizes Physician Payment Sunshine disclosure rules later this year.

PSA Prostate Cancer Screening Does More Harm Than Good, USPSTF Concludes

m.houghton@elsevier.com — Mon, 28 May 2012 00:00:00 -0400

The final recommendations are a major shift in policy for the commonly performed blood test, and one certain to face ongoing controversy.

Senate FDA Bill: Device Provisions

Mon, 28 May 2012 00:00:00 -0400

The Senate-approved Food and Drug Administration Safety and Innovation Act includes dozens of sections related to devices.

News In Brief

Mon, 28 May 2012 00:00:00 -0400

DaVita buys HealthCare Partners. Boston Scientific/Philips imaging collaboration.

FDA Panel: Heart Closure Device Safety Data Demands Further Study

z.miners@elsevier.com — Mon, 28 May 2012 00:00:00 -0400

More study is required to make sense of the adverse event rates associated with two marketed atrial septal defect occluders, a May 24 FDA panel concluded. St.

CT’s Benefits Outweigh Risks In Some 55-And-Older Smokers, Societies Find

z.miners@elsevier.com — Mon, 28 May 2012 00:00:00 -0400

The new recommendations are based on a meta-analysis of eight randomized trials and 13 cohort studies of low-dose computed tomography screening for lung cancer, including the large, federally funded National Lung Screening Trial.

POD Primer: Some Physician-Owned Device Distributors Can Pass Muster

s.darcey@elsevier.com — Mon, 28 May 2012 00:00:00 -0400

The best physician-owned distributors “do not bill Medicare at all,” POD-supporter Truhe said at a May 21 meeting. Instead, the distributors can sell a variety of implantable devices to hospitals, without steering the hospital to buy just one manufacturer’s wares.

People In Brief

s.darcey@elsevier.com — Mon, 28 May 2012 00:00:00 -0400

Vincent Forlenza becomes chairman of BD. Richard Meelia joins Apollo Endosurgery board.

Digital Health In Brief

m.hogan@elsevier.com — Mon, 28 May 2012 00:00:00 -0400

Comcast Ventures invests in BodyMedia. Qualcomm Life forms advisory council.

Sunshine Heart Gears Up For Heart Failure Implant Pivotal Trial

d.tahir@elsevier.com — Mon, 28 May 2012 00:00:00 -0400

Firm preps for U.S. pivotal trial and European market launch in the third quarter for its minimally invasive, extra-aortic balloon counter-pulsation system for moderate to severe heart failure.

Brookings Workshop Explores Cultural Changes Needed To Drive mHealth

m.hogan@elsevier.com — Mon, 28 May 2012 00:00:00 -0400

Physicians and patients may need to become more comfortable with giving up some privacy in exchange for achieving better clinical outcomes, speakers suggested at a Brookings Institution workshop.

FCC Chairman Sings MBAN Praises In Advance Of May 24 Spectrum Vote

m.hogan@elsevier.com — Mon, 21 May 2012 00:03:00 -0400

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.

Latest Senate FDA Reform Bill Would Delay Guidance On Mobile Health Apps

rebecca.kern@elsevier.com — Mon, 21 May 2012 00:01:00 -0400

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.

New Coverage-With-Evidence-Development Guidance In The Works Following MedCAC Meeting

m.hogan@elsevier.com — Mon, 21 May 2012 00:01:00 -0400

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.

"Medical Device Complaint Handling" Special Report

Mon, 21 May 2012 00:00:00 -0400

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?

Not So Special? FDA Proposal Would Damage Streamlined 510(k) Submissions Program, Firms Say

d.filmore@elsevier.com — Mon, 21 May 2012 00:00:00 -0400

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.

Research In Brief

d.filmore@elsevier.com — Mon, 21 May 2012 00:00:00 -0400

Details from St. Jude's FAME II study on fractional flow reserve technology.

Public Hearing: IRS Tight-Lipped On Industry Device Tax Concerns

z.miners@elsevier.com — Mon, 21 May 2012 00:00:00 -0400

IRS remained mostly in listening mode during a recent public hearing on the impending device tax held at its headquarters in Washington, D.C.

Agilent Builds Cancer Diagnostics Biz Via Dako Acquisition For $2.2 Billion

z.miners@elsevier.com — Mon, 21 May 2012 00:00:00 -0400

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.

FDA Holds Up HeartWare LVAD Trial In Less Advanced Heart Failure Patients

d.filmore@elsevier.com — Mon, 21 May 2012 00:00:00 -0400

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.

New Products In Brief

Mon, 21 May 2012 00:00:00 -0400

Recent approvals and launches include St. Jude Medical’s EnligHTN renal denervation system for hypertension and Zeltiq Aesthetics’ expanded CoolSculpting clearance for fat reduction.

U.K. Health Dept. Recommends Stronger Adverse Event Reporting System In Wake Of Breast Implant Scandal

l.radick@elsevier.com — Mon, 21 May 2012 00:00:00 -0400

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.

News In Brief

Mon, 21 May 2012 00:00:00 -0400

CryoLife buys Hemosphere. Medtronic Infuse case closed.

FDA Proposes Sliding-Scale Paradigm For Obesity Device Trials

Mon, 21 May 2012 00:00:00 -0400

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.

Financings In Brief

Mon, 21 May 2012 00:00:00 -0400

Cancer Genetics plans initial public offering. Mitralign raises $35 million for valve repair device.

Couples Therapy: VC Discusses Challenges In Companion Diagnostic-Biopharma Relationships

c.kelly@elsevier.com — Mon, 21 May 2012 00:00:00 -0400

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.

Regulatory News In Brief

m.houghton@elsevier.com — Mon, 21 May 2012 00:00:00 -0400

J&J queries FDA on the intricacies of device product codes and unique device identifiers. Biologics center strategic plan touches on diagnostics.

FDA Warning Letters Released The Weeks Of May 1 Through May 15

Mon, 21 May 2012 00:00:00 -0400

Recent warnings to medical device manufacturers.

OraSure In-Home HIV Test’s Promise Outweighs Risks, Panel Concludes

rebecca.kern@elsevier.com — Mon, 21 May 2012 00:00:00 -0400

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.

FDA Recalls List – May 9, 2012

Mon, 21 May 2012 00:00:00 -0400

CLASS II FastPlan Treatment Planning System Manufacturer: Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA.

FDA’s April 2012 Clearances Of 510(k)s

Mon, 14 May 2012 00:00:00 -0400

Agency signs off on 252 devices via 510(k) during the month.

Patients Could Play A Role In PCORI Research Application Reviews – Exec Director Selby

g.twachtman@elsevier.com — Mon, 14 May 2012 00:00:00 -0400

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.

Webinar: Metrics for an FDA-Compliant Quality System: CAPA, Complaints, Supply Chain, Design and Validation

Mon, 14 May 2012 00:00:00 -0400

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.

People In Brief

s.darcey@elsevier.com — Mon, 14 May 2012 00:00:00 -0400

The latest moves by movers and shakers in the medical device and diagnostics industries

Obesity Device Makers Debate Merits Of CMS Gastric Sleeve Coverage Proposal

m.hogan@elsevier.com — Mon, 14 May 2012 00:00:00 -0400

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.

Fireworks Kept At Bay As Congress Pushes To Enact FDA Reforms By July 4

Mon, 14 May 2012 00:00:00 -0400

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.

Research In Brief

Mon, 14 May 2012 00:00:00 -0400

Data updates from HRS, SCAI meetings, and more.

FDA Will Not Broadly Release Report Criticizing EU Oversight

rebecca.kern@elsevier.com — Mon, 14 May 2012 00:00:00 -0400

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.

Government, Industry Seek To Stimulate Telemedicine Growth

m.hogan@elsevier.com — Mon, 14 May 2012 00:00:00 -0400

American Telemedicine Association annual meeting April 29-May 1 in San Jose, Calif., hosted about 4,600 attendees.

New Products In Brief

Mon, 14 May 2012 00:00:00 -0400

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.

DME Suppliers Await CBO Score On Competitive Bidding Alternative

s.darcey@elsevier.com — Mon, 14 May 2012 00:00:00 -0400

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.