Zebra Medical Vision Gains FDA Clearance for Spine Fracture AI Solution
Zebra-Med secured clearance for a product helping to identify more patients at risk of osteoporosis, as 70% of VCFs are underdetected globally.
Regulatory
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Foresee-X Smart Surgical Glasses Gain CE Mark Approval
The system allows for reduction in the use of external monitors during trauma procedures, thereby minimizing radiation exposure among other benefits.
Corin’s OPSInsight Gains FDA Clearance for Total Hip Replacement
The new cloud-based software brings Corin's Optimized Positioning System onto a dynamic online platform for use in total hip arthroplasty.
Pixee Medical Granted CE Mark for Augmented Reality Knee Replacement Navigation
Knee+ technology combines computer vision and deep learning algorithms and works with off-the-shelf AR glasses to track instruments and implants.
Naviswiss Gains Japan Regulatory Approval for Hip Navigation
Naviswiss is entering the Japanese market with its miniaturized surgical navigation for hip replacement.
LimaCorporate, TechMah Gain FDA Clearance for Smart SPACE Digital Technology
LimaCorporate received FDA 510(k) clearance to market the Smart SPACE Shoulder 3D Planner & 3D Positioner.
THINK Surgical Gains FDA Clearance for Robotic Knee Replacement Application
THINK Surgical received FDA 510(k) clearance to market the TSolution One® Total Knee Application for pre-surgical planning.
Brainlab’s Cirq Robotics Gains FDA Clearance for Spine
Brainlab received FDA 510(k) clearance to market Cirq® Robotics in the U.S. for spinal applications.
Medacta Receives Japan Regulatory Approval for MyShoulder Placement Guides
Medacta gained regulatory approval for MyShoulder Placement Guides in Japan, for use in arthroplasty procedures.
MiRus Receives FDA 510(k) Clearance for GALILEO Spine Alignment Monitoring System
MiRus received FDA 510(k) clearance for the GALILEO Spine Alignment Monitoring System.