DePuy Synthes Spine has seen its SYNAPSE™ Occipital-Cervical-Thoracic (OCT) System cleared for expanded indications
Approval/Clearance
FDA Clears CoolSculpting® Therapy for Lower Temperatures/Shorter Treatment Times
Cosmetic treatment technology company ZELTIQ® Aesthetics, Inc., has clinical data supporting its change of treatment parameters
FDA Approves First Flexible-Tipped Cardiac Ablation Catheter
St. Jude’s FlexAbility is the first flexible tipped ablation device for the treatment of cardiac arrhythmias to gain U.S. approval
CE Mark for InspireMD’s New CGuard RX, Carotid Embolic Protection Stent System
InspireMD, Inc. tells us it has received CE mark approval for its new CGuard RX rapid exchange system for its MicroNet™ covered carotid stent technology.
Pediatric Clearance for EOS Imaging’s Micro Dose Reduces Radiation Worry
System offers potential to reduce radiation exposure during orthopedic imaging in patients requiring repeat visits
FDA Nod Means Shared Glucose Monitoring Reality Using Apps
Now people with diabetes as young as 2 years of age can automatically and securely share real-time CGM data from their Dexcom receiver to a caregiver’s mobile app
First MRI-Conditional Cochlear Implant Approved in U.S.
MED-EL USA has announced U.S. FDA approval of its new SYNCHRONY cochlear implant, the first time such a device has been approved for use with 3.0 Tesla MRI without the surgical removal of the internal magnet.
CE Mark and Launch for AliveCor AF Detection Function
AliveCor, Inc. has received CE Mark clearance for an automated atrial fibrillation detection function on its AliveCor® Heart Monitor.
FDA Clears K2M’s New Mesa® 2 Pedicle Screw System
Mesa 2 claims quicker on/off capability and one-step locking.
FDA Clearance for Handheld Bladder Scanner
Medical device company, Signostics, has gained U.S. FDA (510(k) clearance for its SignosRT Bladder, the company’s new hand-held bladder scanner.
Good News for BPH Sufferers as MIS Embolization Procedure Gains CE Mark
“Prostatic Artery Embolization offers a safe and effective treatment option for men.”
CE Mark for Silk-Enhanced Biological Bone Graft
Silk from moths enhances cohesion and mechanical properties of new bone graft
FDA Approves First Obesity Treatment Device for Ten Years
Enteromedics is celebrating approval of its novel neuroscience-based technology that it says enables safe, durable eeight loss
FDA Clears Valorem Surgical® MaxiMIS™ Spinal Fixation System
Valorem Surgical has received FDA clearance and seen a first U.S. case utilizing its minimally invasive MaxiMIS™ Spinal Fixation System.
FDA Clears t:flex™ Largest Capacity Insulin Pump
Insulin pump maker, Tandem Diabetes Care®, Inc. has gained U.S. FDA clearance to market the t:flex™ Insulin Pump, with its 480 unit reservoir.
Expanded Clearance for Intact® Tissue Excision System
Intact Medical Corporation’s marketing clearance sees it usable for remove intact breast lesions up to 30mm in diameter.