FDA Clears Profound’s Prostate Tissue Ablator August 16, 2019 Surgeons can use the device for ablation procedures on both malignant and benign tissue types. Read More
V-Wave’s Heart Failure Shunt Snags Breakthrough Designation August 15, 2019 The device is designed to relieve symptoms, reduce hospitalization, increase exercise tolerance and improve patients’ quality of life. Read More
Pavmed’s Carpal Tunnel Treatment Sees Successful Use in Resubmission Safety Study August 15, 2019 The company said it will resubmit the CarpX 510(k) application with the new safety and effectiveness data. Read More
Restoration Robotics Gains European Approval for Hair Restoration System August 15, 2019 The system automates significant parts of hair transplantation procedures. Read More
FDA Hands Breakthrough Designation to Ascyrus’ Dissection Stent August 15, 2019 The stent reduces the size of the aorta. Read More
FDA Clears Standalone Cervical Interbody Fusion System August 14, 2019 The device has its own bone screw fixation and needs no additional fixation. Read More
Misonix Earns CE Mark for Ultrasonic Surgical Device August 13, 2019 The platform features a new digital algorithm that provides more control. Read More
FDA Grants Breakthrough Designation for Balloon Catheter August 13, 2019 No incidents of device and procedure-related mortality were reported in an ongoing clinical study Read More
FDA Clears Binx Health Diagnostic for STDs August 13, 2019 The test delivers results in about a half hour. Read More
China Gives Innovative Device Designation to Cancer Treatment August 12, 2019 The designation puts Optune on a faster approval track. Read More
Shimadzu’s Earns 510(k) Clearance for Radiographic Table August 12, 2019 The system supports chest, abdomen, or extremities along with Upper GI's, modified swallows and even joint injections. Read More
Endologix Grabs IDE for Aneurysm Sealing Protocol August 12, 2019 The new technology will help “patients that are underserved by the current standard of care,” the devicemaker said. Read More