FDA Grants Approval to Obalon Balloon System September 13, 2016 There were 387 patients in the U.S. across 15 clinical trial sites in the study. Read More
FDA Gives ‘Go Ahead’ to Omega3-Rich Fish Skin for Surgical Applications September 13, 2016 Kerecis’s Omega3-rich fish skin has received clearance from the FDA for marketing as a surgical reinforcement in the U.S. Read More
EBR Systems Obtains FDA Approval to Begin Study of Wireless Cardiac Pacing System for Heart Failure September 13, 2016 The company’s device is designed as an endocardial pacing system. Read More
Ossix Volumax Receives FDA 510(k) Clearance September 12, 2016 This product is designed to restore lost volume in periodontal regeneration. Read More
NovaBay Pharmaceuticals’ Neutrox Receives CE Mark and ISO Certification September 12, 2016 Neutrox is NovaBay’s hypochlorous acid used in their Avenova eye care product. Read More
Ethicon Widens Portfolio with Addition of Enseal X1 Large Jaw Tissue Sealer September 12, 2016 The device designed for surgeons to use during open procedures such as colectomies and hysterectomies. Read More
FDA Grants Approval to SyntheticMR’s MAGiC September 9, 2016 MAGiC is the industry’s first multi-contrast magnetic resonance (MR) technique. Read More
FDA Grants IDE Approval to Monteris Medical’s NeuroBlate Laser System September 8, 2016 GBM is the most common and deadliest type of primary brain tumor. Read More
Carestream’s OnSight 3D Extremity System Gets FDA 510(k) Clearance September 8, 2016 This device enables healthcare providers to capture 3D images. Read More
FDA Approves Clot Retrieval Devices for Preliminary Stroke Treatment September 8, 2016 The first-time approval allows the devices to be used alongside a tissue plasminogen activator. Read More
OrthoSera Receives CE Mark for hypACT Device to Restore Osteoarthritic Bone September 7, 2016 The company has developed a hyperacute serum technology to be used to treat osteoarthritis. Read More
FDA Gives De Novo Classification for Concussion Assessment Device September 6, 2016 The device measures neurocognitive functioning for managing concussions. Read More