A new FDA policy aiming to boost access to digital health devices for treating psychiatric disorders during the COVID-19 pandemic is creating new opportunities for digital therapeutic manufacturers.
Akili Interactive Labs, a Boston-based company that seeks to deliver digital medicine through video games, began rolling out its still-under-review ADHD treatment Wednesday at no cost to qualifying users under the policy, which like FDA’s other COVID-19 guidance documents applies for the duration of the public health emergency.
Prior to the COVID-19 era, digital therapeutics was gaining steam with regulators, payers, and prescribers as a viable treatment option or supplement across a range of diagnoses. The still relatively nascent category saw investments increase by an average of 40% annually over the past seven years, topping $1 billion in 2018, according to research cited in a McKinsey report last month. Digital therapeutic
Amassing enough clinical evidence to back the use of those digital health interventions has been an important goal for companies in the sector and, as is the case for other products regulated by FDA, a barrier to entry for some developers.
Pear Therapeutics’ inaugural product, an app-based, prescription-only treatment for substance use disorder, gained an FDA De Novo authorization in 2017, creating the product classification for computerized behavioral therapy devices for psychiatric disorders and allowing for follow-on 510(k)s.
But in light of the COVID-19 pandemic, FDA moved to temporarily lower some of those barriers — including the necessity for 510(k) submissions, certain clinical evidence standards, and registration and listing requirements — for low-risk technologies that could provide relief to individuals with anxiety, depression, insomnia, ADHD, PTSD, and autism, among other psychiatric disorders.
Read the complete article at Medtechdive.com
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