An implantable drug pump that Medtronic Inc. recalled has a potentially life-threatening design problem, says the U.S. Food and Drug Administration.
Regulatory
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Midday panel discussion on day one of FDA’s Sept. 12 and 13 workshop on its draft guidance for mobile medical device applications.
Hemosphere Receives CE Mark Approval for the HeRO ® Graft
Hemosphere Opens European Union Market for Future Growth Opportunities Building Upon
HeRO® Graft’s Success in the United States
FDA Clears IsoRay, Inc. (ISR)’s GliaSite(R) Treatment for Brain Cancer
IsoRay, Inc. announced today that the FDA has cleared its GliaSite® radiation therapy system, a balloon catheter device used in the treatment of brain cancer.
Cochlear Limited Slumps Most in 7 Years on Recall
Cochlear Limited is undertaking a voluntary recall of the unimplanted Cochlear Nucleus CI500 cochlear implant range.
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
MiCardia Corporation Receives CE Mark for the enCorSQ Mitral Valve Repair SystemTM
MiCardia Corporation announced today that it has received the CE-Mark approval for commercial sales of its enCorSQ Mitral Valve Repair System in Europe and select countries worldwide.
OptiMedica Receives CE Mark For Catalys™ Precision Laser System
Global ophthalmic company OptiMedica Corp. has announced that it has received CE mark approval to market its Catalys Precision Laser System for cataract surgery in Europe.
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.
NICE recommends warming mattress
NICE (National Institute for Health and Clinical Excellence, UK) has published guidance supporting the use of a patient warming mattress from a Yorkshire company to prevent hypothermia during surgery.
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.
Consumer groups tell FDA panel to recall J&J breast implants
Consumer groups at this week’s FDA advisory panel on general and plastic surgery devices ask the watchdog agency to take Johnson & Johnson breast implants off the market until more safety data can be gathered.
Masimo brain function monitor receives CE mark
Masimo has received CE mark for its SEDLine brain function monitor with four separate EEG channels in a single integrated algorithm.
Warning letter: FDA unleashes laundry list of accusations against Beckman Coulter
The FDA warns Beckman Coulter on multiple quality issues at its California manufacturing plant, including issues related to its Class 1 recall of an electrolyte assay in May
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.