Regulatory Approvals

New Soldier® High Flow Microcatheter Granted FDA Clearance

Embolx Inc., a leading medical technology company developing microcatheters for arterial embolization procedures, is thrilled to announce that the U.S. Food and Drug Administration...

Spectral AI’s DeepView software secures UKCA authorisation

Spectral AI has received UK Conformity Assessed (UKCA) authorisation for its DeepView AI-Burn predictive software. The authorisation allows the system to aid in burn wound...

Virtual Incision secures FDA authorisation for MIRA Surgical System

Virtual Incision has received the US Food and Drug Administration (FDA) marketing authorisation of the MIRA Surgical System (MIRA) for colectomy procedures in adults. MIRA...

SeaStar’s device granted humanitarian exemption approval for children with AKI

Following positive clinical results, the US Food Drug Administration (FDA) has granted SeaStar Medical a humanitarian device exemption (HDE) approval for its Quelimmune selective...

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)...
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