Medical Device | January 08, 2026
Stereotaxis scores FDA nod for groundbreaking MAGiC robotic heart catheter
The MAGiC catheter is designed for robotically-navigated cardiac ablation procedures
The MAGiC catheter is designed for robotically-navigated cardiac ablation procedures
The trial’s primary endpoint is the mean change in HbA1c from baseline, while secondary endpoints include changes in fasting blood glucose, body weight, and overall safety
WCK 5222 is the first New Chemical Entity (NCE) discovered and developed in India to be submitted for pan-European marketing authorisation
Currently approved for patients eight and older, Tzield could now be used to delay the onset of stage 3 type 1 diabetes (T1D) in children diagnosed with stage 2 T1D
The company is pursuing the accelerated FDA 505(b)(2) approval pathway for its once-daily oral ondansetron formulation
The FDA acknowledged that Corcept’s pivotal GRACE trial met its primary endpoint and that data from the GRADIENT trial offered confirmatory evidence
Theracor is derived from human umbilical cord extracellular matrix (ECM) and is designed to cover, protect, and maintain a moist wound environment
The Toumai platform, currently the only robotic system with US FDA Study Approval for telesurgery, enabled real-time surgical control with no compromise to patient safety
INOVIO remains confident in the therapy’s benefits and intends to meet with the FDA to discuss maintaining eligibility under this pathway
Lucid-MS represents a potential breakthrough in the treatment of multiple sclerosis
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