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 [...]
Magnus Medical Launches With Breakthrough Device Designation for Rapid, Individualized Treatment of Major Depression and $25M in Series A Financing
The Magnus System is based on the SAINT technology, which [...]
Samsung Receives FDA Clearance for AI Algorithms that Detect Lung Nodules in Chest X-rays
“This FDA clearance is a huge milestone for Samsung and [...]
Naviswiss Receives FDA 510k Clearance for Naviplan
The Naviplan hip application is CT-based and assists the surgeon [...]
DreaMed Launches its FDA-Cleared Diabetes Management Platform with a Leading U.S. Children’s Hospital
Advisor Pro is the first decision support system to receive [...]
Alpha Tau Receives FDA’s Breakthrough Device Designation for the RX of Recurrent Glioblastoma Multiforme
“As GBM is such a terrible disease, it is critical [...]
FDA Announces Signing of Domestic Mutual Reliance Agreements with California, Florida, Utah and Wisconsin
These Mutual Reliance agreements facilitate a coordinated effort between the [...]