Today's News

Medicare Panel Looks To Upcoming Study To Fill Evidence Gaps For Carotid Artery Disease / There is a lot more to learn about which treatment to choose for carotid atherosclerosis patients, Medicare advisors said this week. A new trial in the works that would compare both surgery and stenting to standalone medical therapy presents a good opportunity to fill the gaps. / “The Gray Sheet”

Regulatory

510(k) Guidance Footnote May Signal Greater FDA Oversight Of Preclinical Testing / Device industry experts say a seemingly minor footnote to the recent 510(k) program draft guidance could create a new requirement for nonclinical studies. / “The Gray Sheet” Jan. 23, 2012

ClinicalTrials.gov: NIH Busy Educating Sponsors On Mandates While Regs Remain In The Works / Draft rules are still being developed to fully implement ClinicalTrials.gov, but the law has been in effect for some time and officials say they are making a consistent effort to ensure study sponsors are educated on their new responsibilities. / “The Gray Sheet” Jan. 23, 2012

Next Step On the Innovation Pathway: Renal Disease Devices / FDA issued an “innovation challenge” Jan. 12 asking companies developing devices for end-stage renal disease to volunteer for a pilot program designed to assess new statistical tools and collaborative processes that the agency hopes will accelerate product development. / “The Gray Sheet” Jan. 23, 2012

Regulatory News In Brief / The latest FDA guidances and other regulatory updates for device makers. / “The Gray Sheet” Jan. 23, 2012

Trade Groups Taking Extra Steps To Ensure Start-Ups' Regulatory Know-How / AdvaMed and the Medical Device Manufacturers Association take steps to keep pace with a changing regulatory and policy environment for smaller device makers. / “The Gray Sheet” Jan. 23, 2012

Reimbursement

Many Medicare Demos Do Not Reduce Spending, CBO Reports / Medicare demonstration projects may need more careful design to meet cost-saving goals, says the Congressional Budget Office. Better methods to evaluate the success of demos are also necessary, the budget office argues in a January 2012 report. / “The Gray Sheet” Jan. 23, 2012

New Products

New Products In Brief / WL Gore’s endovascular graft for aortic tears and J&J/LifeScan’s OneTouch Verio IQ blood glucose monitor are among new products on the market. / “The Gray Sheet” Jan. 23, 2012

Business

Financings In Brief / Aria Diagnostics and Gene Security Network/Natera raise funds for non-invasive prenatal test development. More financings. / “The Gray Sheet” Jan. 23, 2012

News In Brief / Industry guides on ethical distribution pacts. Stryker settles charges over OP-1 marketing. / “The Gray Sheet” Jan. 23, 2012

Clinical Trials

Fractional Flow Reserve Proves Itself Early In St. Jude’s FAME II Study / St. Jude Medical’s fractional flow reserve technology gave stenting a significant enough edge in stable coronary disease patients that a monitoring board recommended stopping the study early because it would be unethical to continue to randomize patients to the optimal medical therapy control group. / “The Gray Sheet” Jan. 23, 2012

Research In Brief / Data reports on obesity devices, bone density screening and more. / “The Gray Sheet” Jan. 23, 2012

International

International News In Brief / Forming a single European device-diagnostics industry federation; the “scandal” of U.K. device regulation; more international news. / “The Gray Sheet” Jan. 23, 2012

Recalls

Covidien’s Recalled Thoracic Surgery Stapling Indication Generated Roughly $33 Mil. In Sales / Firm cites reports of 13 serious injuries and three deaths related to use of Duet TRS in the thoracic cavity. / “The Gray Sheet” Jan. 23, 2012

FDA Recalls List – Jan. 11, 2012 / Recent medical device recalls. / “The Gray Sheet” Jan. 23, 2012

Comparative Effectiveness

PCORI Draft Research Agenda Offers Only Broad Areas Of Study / The Patient-Centered Outcomes Research Institute issues its draft national priorities and research agenda for comment Jan. 23. Rather than specific research items, the list contains five broad areas designed to elicit the greatest amount of input from stakeholders on what projects should be funded. / “The Gray Sheet” Jan. 23, 2012

Compliance & Enforcement

CDRH Following Up More Actively On Complaints Against Manufacturers / New system will track and triage complaints filed against device companies. / “The Gray Sheet” Jan. 23, 2012

FDA Warning Letters Released The Weeks Of Jan. 2-16 / Recent warnings to medical device manufacturers and marketers. / “The Gray Sheet” Jan. 23, 2012

Digital Health

Mobile Devices For Blood Pressure Checks Highlighted In Heart Campaign / Public-private “Million Hearts” campaign to reduce the heart attack and stroke rate by one million by 2017 will emphasize mobile technology for monitoring blood pressure. / “The Gray Sheet” Jan. 23, 2012

Health Care Reform

Quest 'High Performing' Hospitals Save $4.5 Billion Over First Three Years / A collaborative representing 157 hospitals in the Premier health care alliance saved 24,820 lives and billions of dollars in its first three years. / “The Gray Sheet” Jan. 23, 2012

Publishers Spotlight

IN3 Medical Device 360° 2012 - Orlando / Publisher’s Spotlight: Elsevier Business Intelligence is proud to announce a powerful new event for today's medical technology executive: The Investment in Innovation (IN³) Medical Device 360° Conference, being held February 29-March 2, 2012, at the Ritz-Carlton Orlando, Grande Lakes.  / “The Gray Sheet” Jan. 23, 2012