U.S company, FlowAid Medical Technologies Corp., has received CE mark approval for its FA100 SCCD Sequential Contraction Compression Device.
Approval/Clearance
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
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
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
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
CE Mark for Ellipsys® Vascular Access System
Vascular Access specialist Avenu Medical gains European approval and closes in on U.S.
Seal of Approval for TissuePatch™ in China
Chinese approval for TissuePatch™ makes it the first and only sealant film to gain access to one of the world’s biggest markets
Last Hurdle Jumped as FDA Approves Integra® Omnigraft™ Dermal Regeneration Matrix Packaging
FDA green light for commercialisation of diabetic foot ulcer graft
FDA Clears EndoGastric Solutions’ Next Generation EsophyX® Device
EsophyX® Z fastener delivery system now requires fewer steps for Transoral Incisionless Fundoplication (TIF) procedures
CE Mark for Planmed Clarity 3D, DBT System
Finnish technology company sees its 3D Tomosynthesis and 2D full field mammography systems ready for EU market
World’s Smallest Pacemaker Gains U.S. Approval
Medtronic’s Micra® TPS is the first transcatheter pacemaker to be approved in the U.S., giving patients access to the most advanced pacing technology at one-tenth the size of traditional devices
CE Mark for St. Jude’s Expanded Selection of Quadripolar Pacing Leads
Cardio device titan will now proceed to EU launch of range adds, claiming largest portfolio of quadripolar leads
Smartinhaler™ Company Sets Stall Out in U.S.
Adherium establishes North American operation and appoints Senior Vice President of Business Development to lead market expansion