The US robotics company is ramping up its go-to-market strategy ahead of potential US Food and Drug Administration (FDA) clearance in the second quarter of 2025 (Q2 2025).
has prompted the biotech to seek discussions with regulators about the design of a pivotal trial. The new results, presented at the Association for Research in Vision and Ophthalmology (ARVO ...
The trial of the app is being conducted in children aged six to 17 with ADHD, with a target enrolment of 150, and is designed to support regulatory approval in Japan. It is the first pivotal study ...