FDA Accepts Label Update for Plasma IQ™, the First FDA-Cleared Handheld Plasma Energy Device
The removal of this specific contraindication was due in part [...]
Medtronic Reports FDA Approval of Spinal Cord Stimulation Therapy for Treating Chronic Pain Resulting from Diabetic Peripheral Neuropathy
This new indication enables us to apply Medtronic’s more than [...]
Cardiovascular Systems, Inc. and OrbusNeich Announce FDA PMA Approval of Scoreflex® Scoring Balloon
Scott Ward, CSI’s Chairman, President and Chief Executive Officer, said, [...]
BD Introduces Smart Connected Robotics to Automate Microbial Identification (BD Kiestra™)
“The BD Kiestra IdentifA system transforms the manual workflow into [...]
NuVasive Receives FDA Clearance for Expanded Indications of Use for Attrax Putty with Company’s Thoracolumbar Interbody Portfolio
“The expanded indications of Attrax Putty with thoracolumbar implants support [...]
Zynex Submits FDA Application for its Next Generation Fluid and Blood Volume Monitor
The Zynex Fluid Monitoring System (CM-1500) is a 100% non-invasive [...]
Paragon 28, Inc. R3ACT™ Stabilization System Cleared by FDA
The R3ACT Stabilization System, expected to commercially launch in early [...]
Nobel Biocare Receives FDA 510(k) Clearance for the Nobel Biocare N1™ Implant System
More than an implant, N1 is a comprehensive system of [...]
MOWOOT earns FDA’s First-Ever ‘Breakthrough Device Designation’ for a Novel Non-Drug and Non-Invasive Therapy of Neurogenic Bowel Disorder
“The Breakthrough Device Designation is a significant milestone for our [...]
Blackrock Neurotech’s MoveAgain Brain-Computer Interface System Receives Breakthrough Device Designation from the FDA
The FDA Breakthrough Device designation aims to expedite the review [...]