UK MHRA report shows 13% uplift in adverse incident reports year on year.
Regulatory
Innocoll Announces European Approval for CollaGUARD®, Surgical Adhesion Barrier
Innocoll Inc. has announced the approval of CollaGUARD surgical adhesion barrier for the prevention of postoperative adhesions following abdominal and pelvic surgery.
Medtronic Announces 510(k) Clearance for the Aquamantys®3 System with Combined Hemostatic Sealing and Cutting Functionality
Medtronic, Inc. has announced that it has received 510(k) clearance from the Food and Drug Administration (FDA) for its Aquamantys®3 System as well as the new 8.2L Bipolar Sealer with Cutting and 6.0 Bipolar Sealer hand pieces.
Unisense FertiliTech’s EmbryoScope® Receives FDA 510(k) Clearance for day 5 culture of human embryos in IVF
Danish company Unisense Fertilitech has announced the gaining of FDA approval for its EmbryoScope® for clinical use in the United States.
GE Healthcare Announces FDA 510(k) Clearance of SenoBright Contrast Enhanced Spectral Mammography (CESM) for Breast Cancer Diagnosis
GE Healthcare (NYSE:GE), has announced FDA 510(k) clearance of an innovative technology to aid the physician in breast cancer diagnosis.
New Duodenal Stent gains FDA approval: Provides Relief to Patients with Advanced Small Intestine Cancer
Cook Medical has announced that its Evolution® Duodenal Controlled-Release Stent was recently granted 510(k) clearance by the Food & Drug Administration (FDA)
Titan Spine Receives FDA Clearance to Launch Endoskeleton ® TAS ALIF Interbody Fusion Device with Integrated Fixation
Titan Spine, has announced that it has received FDA clearance to commercially release its Endoskeleton® TAS system, consisting of an ALIF device with integrated fixation screws.
CorMatrix ECM gains FDA approval for Carotid Repair
Food and Drug Administration (FDA) has granted the company 510(k) clearance to market its CorMatrix® ECM® for Carotid Repair, which utilizes the company’s proprietary ECM Technology.
Independent conference pre-vetting system for the European medical technology industry to be launched in 2012
Eucomed, Europe’s association for the medical technology industry, is to enforce a system to review and approve third-party medical educational conferences in accordance with its Code of Practice.
SORIN GROUP LAUNCHES SONR® SENSOR BASED CARDIAC RESYNCHRONIZATION THERAPY (CRT) OPTIMIZATION SYSTEM
Sorin announced at the Venice Arrhythmias 2011 Congress, CE Mark approval and the European commercial launch of its innovative SonR CRT optimization system
FDA in the Spotlight again as All Metal Hip Implants and Brain Stents Referenced as Examples of Harms Created by Underregulation
Republicans have been urged to hold hearings to examine certain medical devices, which have developed serious defects after being implanted in patients.
ISTO Technologies Receives CE Mark for InQu Bone Graft Substitute and Extender
ISTO Technologies, Inc., has announced that it has received the CE Mark approval for its InQu® bone graft substitute and extender, enabling the company to initiate a commercial launch of the product in Europe.
Cook Medical’s Zilver® PTX® Drug-Eluting Stent Technology Receives Unanimous Recommendation from FDA Advisory Committee
Two years after receiving CE mark approval, Cook Medical’s Zilver® PTX® Drug-Eluting Stent Technology has received unanimous recommendation for approval from FDA Advisory Committee
Report: More than 75% of med-tech companies go outside US first
High costs, long review times and increasing unpredictability led more than three-quarters of medical device makers to seek overseas regulatory approval before launching a bid for FDA clearance, according to the largest-ever survey on the 510(k) review process.
FDA approves ‘atmosphere-friendly’ COPD inhaler
The FDA has approved Boehringer Ingelheim’s Combivent Respimat, a propellant-free inhaler for patients with chronic obstructive pulmonary disease (COPD).
St. Jude Medical Announces Approval and Market Launch of New Neurostimulation Lead to Manage Chronic Pain in Japan
St Jude’s Penta surgical lead is designed to help patients with complex pain patterns such as low back pain