An implantable drug pump that Medtronic Inc. recalled has a potentially life-threatening design problem, says the U.S. Food and Drug Administration.
USA
FDA mobile apps workshop: When is a car a medical device accessory?
Midday panel discussion on day one of FDA’s Sept. 12 and 13 workshop on its draft guidance for mobile medical device applications.
Integra LifeSciences Holdings Corporation (IART) Buys Ascension Orthopedics, Inc. for $65 Million
Integra LifeSciences Holdings Corporation (Nasdaq:IART) and Ascension Orthopedics, Inc. (“Ascension”) today announced an agreement for Integra to acquire Ascension, a provider of high quality, innovative products for the foot, hand and shoulder markets, for approximately $65 million in cash, subject to adjustments.
Cook Medical Applauds AdvaMed Report
Cook Medical has come out in support of the Advamed report detailed on these pages in recent weeks, in which it warned of 43000 job losses as a consequence of the proposed Medical Device excise tax..
Study: Device Tax Could Cost Jobs, Stifle Innovation
The medical device tax, if implemented, could cost tens of thousands of jobs, almost double the industry’s total taxes, raise the effective tax rate to among the highest in the world, and harm U.S. competiveness, according to a study released today by the Advanced Medical Technology Association
Med-tech firms fight tax on devices
The new excise tax was approved by Congress to help pay for the health care law. But the medical device industry says it would push good jobs out of the country.
FDA announces new staff training for medical device reviewers
FDA announces new staff training for medical device reviewers:
Training a key step to improving device review program, strategic priorities
Former DePuy Orthopaedics CEO Floyd lands with OrthoWorx
Former DePuy Orthopaedics CEO David Floyd, who departed amid the fallout over the ASR hip implant recall, lands with OrthoWorx, an initiative aiming to boost the orthopedics sector in Indiana.
MEDICAL DEVICE APPROVAL SYSTEM BROKEN BEYOND REPAIR, REPORT FINDS
The IOM recently releasing a report recommending a complete overhaul of the process used by the government to approve medical devices.
FDA may revoke 510(k) clearances for transvaginal mesh products
Recent warnings and pressure from public groups may see transvaginal mesh devices bumped up to a higher risk FDA classification.
FDA May Classify Surgical Mesh Devices as High Risk
Blog from Injury board network discussing 510(k) classification of surgical meshes in context of current high profile medical device-related concerns.
Medtronic Reports Positive Results with CoreValve and Acquisition of Peak Surgical, Salient Surgical Technologies
Investigators reported that cardiac survival of patients, who were implanted with the 21F CoreValve system in 2005 and 2006, was 77.9 percent at two years and 68 percent at four years; in other Medtronic news, company announces completing the acquisition of Peak Surgical Inc. and Salient Surgical Technologies Inc.
Focus on innovation and overseas market, new Medtronic CEO says
“within a decade, Medtronic’s sales in both China and India could exceed its sales in the U.S” says Medtronic CEO Omar Ishrak
FDA Proposes Guidelines That Clarify Benefit-Risk Determinations For Medical Devices
For the first time, the U.S. Food and Drug Administration has provided draft guidance clarifying how benefit-risk determinations are made during premarket review of certain medical devices.
FDA Proposes Guidelines That Clarify Benefit-Risk Determinations for Medical Devices
For the first time, the U.S. Food and Drug Administration has provided draft guidance clarifying how benefit-risk determinations are made during premarket review of certain medical devices.
IOM to FDA: Ditch the 510(k) clearance program for medical devices
The Institute of Medicine’s much-anticipated independent review of the FDA’s 510(k) clearance program for medical devices recommends that the entire program be scrapped in favor of a new protocol to ensure the devices are safe and effective. Medtronic officials and Sen. Scott Brown (R-Mass.) react.