The US Food and Drug Administration (FDA) has granted Breakthrough Device designation for Blackrock Neurotech’s MoveAgain Brain Computer Interface (BCI) System.
The system has been...
Nearly two decades after its NeuroPort Array scored the FDA’s first approval for an implanted electrode panel that sends brain signals to a computer...
Cardialen has received approval from the US Food and Drug Administration (FDA) for an investigational device exemption (IDE) to begin a clinical trial of...
270Surgical Ltd. has received U.S. Food and Drug Administration (FDA) 510(k) clearance of its next generation SurroundScope System. The SurroundScope is the first laparoscopic imaging...
Wision A.I. Ltd, a startup in the field of artificial intelligence assisted diagnostics for gastrointestinal endoscopy, today announced it received the European CE Mark...
The company is developing a digital therapeutic using VR to manage chronic lower back pain. It recently submitted an application for de novo clearance...
- FDA 510(k) Clearance Creates Multi-Vendor, One Click MRI™ Automation Platform to Increase Real-Time MRI Imaging Access and Accuracy for Patients
- New AHA and ACC Guidelines,...
Global surgical robotics company, CMR Surgical (CMR), has received regulatory approval for the Versius® Surgical Robotic System from the Brazilian Health Regulatory Agency, Anvisa, paving the way for...
ReWalk Robotics is picking up the pace on its trek down the FDA's review pathway.
The agency has granted ReWalk’s latest offering a breakthrough device...
