Medical Device | March 31, 2022
USFDA approves Edwards Mitris Resilia valve
The valve has a saddle-shaped sewing cuff that mimics the asymmetric shape of the native mitral valve
The valve has a saddle-shaped sewing cuff that mimics the asymmetric shape of the native mitral valve
Approval is based on results of a multicenter, randomized, open-labeled and controlled IDE clinical study that demonstrated the superiority of Agili-C™ implant to the current surgical standard of care, debridement and microfracture in the knee joint
The companies are now preparing to initiate a Phase 1 trial to assess the safety and immunogenicity of BLB-201 in healthy volunteers
50 µg dose approved for all adults over 50 years of age and immunocompromised adults over 18 years of age
U.S. NIAID-sponsored trial will evaluate heterologous booster regimens, including NVX-CoV2373, after primary series with current USFDA approved or emergency use authorized-vaccines
Cabenuva was co-developed as part of a collaboration with ViiV Healthcare and builds on Janssen's decades-long commitment to combatting HIV
Titan 2 pivotal study to evaluate implantable tibial neuromodulation (TNM) device to help expand patient access to advanced therapy
The FDA decision is primarily informed by the positive results of a proof-of-concept, Phase 2a study evaluating the safety, immunogenicity, and efficacy of a single dose of 120µg RSVpreF in a human viral challenge model in healthy adults 18 to 50 years of age
Data to establish the safety profile and human dose of vaccine candidate
The approval is based on new data from cohorts D and K of the KEYNOTE-158 trial
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