Regulatory Approvals

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

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

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

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

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...