FDA Awards 510(k) Clearance to Visaris Portfolio November 20, 2015 The clearance covers the company’s software, flat panel detectors and various hardware offerings. Read More
Boston Scientific Wins CE Mark for Watchman FLX November 20, 2015 The device is a catheter-delivered heart implant designed to close the left atrial appendage and prevent the migration of blood clots. Read More
CVRx’s Barostim Therapy Receives Expedited Access Pathway Designation November 19, 2015 The implantable system is designed for the treatment of heart failure. Read More
FDA Awards Clearance to Visunex’s PanoCam LT Wide-field Imaging System November 19, 2015 The system is designed for the early detection of vision disorders. Read More
St. Jude Medical Wins FDA Approval for Spinal Cord Stimulation System November 19, 2015 The device contains a non-rechargeable system and an upgradable platform. Read More
Fujifilm SonoSite Wins 510(k) Clearance for iViz Solution November 18, 2015 The device allows clinicians to access patient information, store exam findings, submit reports and consult with remote providers. Read More
Moximed Wins CE Mark for Atlas Knee System November 18, 2015 The device is a next-generation knee joint unloader for pre-arthroplasty patients. Read More
Innovacyn’s Puracyn Plus Professional Formula Wins Canadian Approval November 17, 2015 The formula is designed to improve preparation of the wound bed. Read More
Medtronic Wins FDA Approval for MyCareLink Smart Monitor November 17, 2015 The device is an app-based remote monitoring system for patients with implantable pacemakers. Read More
NeuroSigma Wins CE Mark for Monarch eTNS System November 16, 2015 The device is indicated for the treatment of ADHD in adults and children age 7 and older. Read More
Mallinckrodt Wins FDA Clearance for INOmax DSIR Plus MRI Device November 16, 2015 The device is indicated for delivery of nitric oxide for inhalation during MRI procedures. Read More
Cephasonics Receives CE Mark for cQuest Cicada Subsystem November 13, 2015 The subsystem is a 64-channel ultrasound front-end with AutoFocus beamforming technology. Read More