“Digiceuticals” Are Gaining Steam

“Digiceuticals” Are Gaining Steam

For several months now, the FDA has been approving mHealth apps (also known as digital therapeutics or “digiceuticals”) to treat everything from diabetes to substance abuse. Unlike other mHealth apps, digiceuticals must be tested for efficacy, approved by the FDA and prescribed by physicians. Typically, these apps are used to gather data through either patient engagement or passive monitoring and offer personalized recommendations, enabling real-time guidance for users.

One clinical area where digiceuticals have shown early promise is attention-deficit/hyperactivity disorder (ADHD). In December, Akili Interactive completed a trial demonstrating that use of their high-quality action video game, AKL T01, delivered statistically significant improvements in attention and inhibitory control compared to a group of children who played a different action-driven video game.

As more digiceuticals are successfully utilized for care by physicians and patients alike, production and funding of them are also increasing. Recently Pear Therapeutics, a digiceuticals company, raised $50 million in Series B funding to develop another digiceutical platform after the success of reSET, a digiceutical for treating patients with substance use disorder, which received Expedited Access Pathway designation from the FDA. These high-profile successes have encouraged continued innovation, as at least 150 firms across the globe are developing some sort of digital therapeutic.

mHealth App Speeds Diagnosis of Stroke

Recently, the FDA cleared the mHealth app Contact (also known as the LVO Stroke Platform) for marketing. The Contact app, which was developed by, uses artificial intelligence (AI)–based software to analyze brain CTs for signs of stroke (through the identification of large vessel occlusions). Once identified, the app alerts a neurovascular specialist. Contact was approved in a de novo premarket review pathway based on the results of a retrospective study comparing the accuracy of the app with 2 trained neuroradiologists analyzing 300 CT images.

The app can be used by hospitals to triage patients, streamlining the diagnostic process and accelerating the time to treatment for stroke patients. When the app identifies a large vessel occlusion, it simultaneously notifies the specialist and the frontline provider analyzing the images through a standard review. Through this process, the app can notify the neurovascular specialist earlier than traditional approaches.

As patients increasingly use technology to better manage their health, organizations need to consider not only their current technological capabilities but also the future technology ecosystem. Uncertain as to which technologies will be most impactful moving forward? Tune into the Sg2 on-demand webinar: Disrupters to Watch in 2018.




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