Regulatory Approvals

IMRIS, Deerfield Imaging Receives FDA Clearance for the InVision 1.5 Surgical Theatre

IMRIS, Deerfield Imaging, the global leader in intraoperative imaging, announced that the company has received 510(k) clearance from the U.S. Food and Drug Administration...

Momentum scores FDA clearance for remote monitoring scoliosis app

Canadian company Momentum Health has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Momentum Spine app for remote monitoring...

CALCIVIS® to Launch Revolutionary New Bioluminescent Dental Imaging System in the US After Securing Final Stage Food and Drug Administration Pre-Market Approval

Calcivis is launching its groundbreaking new preventive dental technology in the United States. The business filed a PMA supplement with the FDA for enhancements...

Wandercraft secures expanded FDA approval for Atalante X exoskeleton

France-based medical robotic solutions provider Wandercraft has received expanded US Food and Drug Administration (FDA) approval for Atalante X, its self-balancing robotic exoskeleton. Atalante X...

neuro42 Receives FDA Clearance on Portable and Compact Brain MRI Scanner for Point of Care Imaging

neuro42, a medical technology Company leading the innovation of MRI and robotics for brain related diagnosis and treatment, today announced it has received 510(k)...

Bone Solutions gets expanded FDA nod for Mg OSTEOCRETE in intervertebral procedures

Orthobiologics technology company Bone Solutions has received the US Food and Drug Administration (FDA) 510(k) clearance for an expanded indication of Mg OSTEOCRETE in...

Zynex Receives FDA Clearance for its Next Generation NMES Device

Zynex, an innovative medical technology company specializing in the manufacture and sale of non-invasive medical devices for pain management, rehabilitation, and patient monitoring, today...

FDA clears Tyber Medical’s Tibia Plating System

Tyber Medical, a provider of private-label orthopaedic implants, has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Proximal Tibia...

Mainstay secures FDA approval for MRI labelling on ReActiv8 System

Mainstay Medical has received the US Food and Drug Administration (FDA) approval for full-body MRI conditional labelling for its ReActiv8 Restorative Neurostimulation system. ReActiv8 is...
1...565758...116Page 57 of 116

Latest articles