There are fewer than a handful of prescription video game digital therapeutics with regulatory clearance, but gamification in patient care is proving its worth as a novel way of treating a range of conditions, from vision loss to dyslexia and ADHD. Now, the onus is on lawmakers and insurers to create a clear path towards reimbursement.

Even before a new law granted FDA authority to require studies be underway before accelerated approval, review divisions have, in some cases, given sponsors years of advance notice on expectations around study timing, according to a Pink Sheet review of NME accelerated approvals.

There are fewer than a handful of approved prescription video game digital therapeutics, but gamification in patient care is proving its worth as a novel way of treating a range of conditions, from vision loss to dyslexia and ADHD. Now, the onus is on lawmakers and insurers to create a clear path towards reimbursement.

After a comparatively subdued 2022 in terms of M&A and other deal-making, a strengthening currency and interest in new areas such as digital tools and cell and gene therapy might see a rebound in activity this year, which should also see domestic approvals of several potential blockbusters and more support for bioventures.