Innocoll Inc. has announced the approval of CollaGUARD surgical adhesion barrier for the prevention of postoperative adhesions following abdominal and pelvic surgery.
Approval/Clearance
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.
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
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
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).
BIONESS INC RECEIVES FDA CLEARANCE AND CE MARK FOR ITS NESS H200 WIRELESS SYSTEM FOR HAND PARALYSIS AS A RESULT OF STROKE AND OTHER CENTRAL NERVOUS SYSTEM DISORDERS
Bioness Wireless Hand rehabilitation System gains FDA and CE mark approval. The device’s Wireless capability allows for seamless integration of device into daily life, increasing therapy time and patient compliance.