Shots:
Nyxoah announced the first patient implantation in BREATHE, its US post-approval study evaluating the long-term safety and effectiveness of the Genio System in adults with moderate to severe obstructive sleep apnea (OSA)
The prospective, multicenter study plans to implant up to 229 pts. across up to 25 US centres, with follow-up for up to…
Shots:
This edition explores Digital Vigilance: AI Enhancing Post-Market Safety Monitoring, highlighting how artificial intelligence, real-world data, and digital listening technologies are transforming pharmacovigilance into a proactive, predictive, and patient-centric discipline.
Through expert perspectives, cover stories, and regulatory insights, we examine the opportunities and challenges of AI-driven safety surveillance—from social media signal detection and real-world…

