In a first, FDA clears video game for kids with ADHD
Digital health company Akili Interactive received FDA de novo clearance for its digital therapeutic, a video game intended to improve attention among kids with ADHD.
FDA is looking for new companies to test out its pre-cert pilot program
The regulator is opening up the program to 510(k) submissions, instead of its initial focus on companies moving through the De Novo regulatory pathway.
Beyond IVF: How We’re Revolutionizing Women’s Fertility Health
Dr. Asima Ahmad addresses the challenges multinational employees face when trying to provide fertility benefits.
FDA commissioner further details digital health pre-cert program
FDA Commissioner Scott Gottlieb further clarified the pilot program meant to expedite review of digital health technologies and incorporate real world evidence into the regulatory process.