ETS Wound Care Wins FDA Clearance for Mirragen April 4, 2017 The device is designed to be packed into wounds to manage and control wound fluids. Read More
NICO Wins CE Mark for BrainPath Non-Disruptive Cranial Access Technology April 3, 2017 BrainPath is designed to displace brain tissue as it creates a corridor to the tumor or hemorrhage site. Read More
Singulex Gains CE Mark for Sgx Clarity System April 3, 2017 Singulex will submit data for regulatory clearance of the Sgx Clarity system in the United States. Read More
RenovoRX Expands Indications for Use for Dual-Balloon Catheter March 31, 2017 The RenovoRx uses two balloons, which allows for more targeted therapy. Read More
FDA Clears QIAGEN JAK2 Assay March 31, 2017 The JAK2 assay is the first and only FDA-cleared kit for the JAK2 V617F mutation. Read More
FDA Grants UDI Extension for Soft Contact Lenses March 31, 2017 Assigning a different UDI to each prescription would produce a large number of virtually identical records. Read More
China Clears Ra Medical’s Pharos Dermatology Laser March 30, 2017 Ra Medical gained a CE mark earlier this year for the device. Read More
FDA Awards Marketing Clearance to Bodycad’s Personalized Unicompartmental Knee System March 30, 2017 The device is designed to the patient's anatomical features and kinematics. Read More
Cardiovascular Systems Wins Clearance for Coronary Orbital Atherectomy System in Japan March 30, 2017 The device is designed to both pilot tight, calcific lesions and treat up to 4mm vessels. Read More
NuVasive Receives FDA Clearance for Cervical Interbody Implant System Used in More Than Two Levels March 29, 2017 The device is an interbody cage manufactured from PEEK-Optima. Read More
FDA Clears Providence Medical Technology’s Cervical Cage-L System and Facet Screws March 29, 2017 The devices are used for cervical fusion. Read More
FDA Grants Investigational Device Exemption for Human Trial of Prosthetic Hand March 29, 2017 The device stimulates nerves in the arm to provide sensation as the person uses the prosthetic hand. Read More