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.
With the Rise of AI, What IP Disputes in Healthcare Are Likely to Emerge?
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
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.