Novel balloon catheter with nitinol “scoring” element gains CE mark
Products
CE Mark for Lower Extremity Compresssion Device
U.S company, FlowAid Medical Technologies Corp., has received CE mark approval for its FA100 SCCD Sequential Contraction Compression Device.
U.S. Commercial Launch of Signostics Uscan™ Ultrasound Bladder Scanner
New system promises industry-leading scan accuracy and volume measurement
Palliative Spine Surgery Options Increased with First-Ever FDA Clearance for Cement-Augmented Pedicle Screws
Clearance of Medtronic’s CD Horizon® Fenestrated Screw Set gives spine surgeons a new treatment option for spinal tumors patients
Zimmer Biomet Consults Its Way to Success with Signature Solutions™ Care Platform
These days, at least in orthopedics, outcomes demonstrably influence the entire business. Zimmer Biomet is aiming to exert positive influence over the care episode which will cement its position as device supplier of choice.
New Stroke Thrombectomy Technology Launched at SNIS 2016
Penumbra launches ACE™68 Reperfusion Catheter with clinical symposium at Neuroointerventional Society annual bash
FDA Approval for Medtronic’s Two-Level Prestige LP™ Cervical Disc System
Prestige LP™ Cervical Disc approved for the treatment of cervical disc disease causing nerve or spinal cord compression at two adjacent levels between the C3-C7 segments
First US Cases for MIS Nasal Valve Collapse Device
Newly cleared minimally invasive device for lateral cartilage support in patients with nasal valve collapse, a major cause of nasal obstruction
FDA Approves St. Jude Medical’s New CRT Software for Managing Heart Failure Patients
St. Jude Medical, Inc., has achieved U.S. FDA approval and announced the launch of its SyncAV™ CRT software which it says will enhance its already comprehensive cardiac resynchronization therapy portfolio.
Medtronic’s NuVent™ Indications Expanded to Include Revision Sinus Surgery
Clinical study conducted on revision subjects supports expanded indication for patients with previously surgically altered tissue
DJO Global Launches New Advanced Cooling Clima-Flex OA Knee Brace
Patients with mild to moderate osteoarthritis knee pain are the target for DJO Global, Inc., with its new Clima-Flex™ OA Knee Brace from DonJoy, offering a new level of comfortable cooling relief through compression and offloading.
New HD Pulmonology Endoscopy System from Pentax Medical Claims Crystal Clear Imaging
The new DEFINA system in Pulmonology combines a state-of-the art HD processor with i-scan imaging technology and two highly maneuverable HD bronchoscopes.
CE Mark and Launch for Eyenuk’s Next Generation EyeArt™ Fully Automated Diabetic Retinopathy Screening Software
New Study of 59,000 patients, presented at EASDec 2016, showed EyeArt 2.0 demonstrating 91 Percent Sensitivity and 90.8 Percent Specificity
Brexit Could Mean Higher Regulatory Hurdles for UK Medical Device Industry
So the deed has been done, UK powers need to get on with the job of leaving the EU, while not actually leaving the EU
New EU Device Regs: No Further Surprises
Changes don’t alter the fact that it’s all about beefing up Notified Bodies and adding stringent Post-Marketing Surveillance… which is good.
FDA Clears SI-BONE’s iFuse Implant System® Updated Indication to Include QOL Claims
iFuse is the only SI Joint Fusion Implant with an FDA cleared indication citing clinical studies that demonstrated improvement in pain, patient function, and quality of life