After the Food and Drug Administration temporarily waived restrictions around software tools for mental health, a handful of digital health companies have already released new solutions to the public. Pear Therapeutics, which already has three FDA-cleared digital therapeutics under its belt, plans to make a product candidate for schizophrenia available on a limited basis.

Called Pear-004, the digital therapeutic is not yet FDA approved. It is intended to be used in conjunction with medication, giving users access to cognitive behavioral therapy and training to help them manage their schizophrenia.

Pear said it plans to give patients access to the tool through collaborations with select healthcare providers and academic centers. So far, Pear said it had seen high patient satisfaction and engagement rates in two clinical studies, though it has not yet conducted a pivotal clinical trial.

“Thanks to FDA’s Emergency Guidance, Pear is pleased to have the opportunity to help people suffering from schizophrenia by providing temporary access to our product candidate, Pear-004, during this time of greater need,” Pear CEO Dr. Corey McCann said in a news release. “We embrace FDA’s guidance to temporarily expand the availability of experimental digital therapeutics to facilitate patient use during a time of heightened stress and to reduce potential exposure to COVID-19.”

Seeing a surge in demand for mental health services during the Covid-19 pandemic, the FDA temporarily waived requirements around low-risk digital health tools in mid-April. That included requirements for companies to submit a 510(k) premarket notification before distributing a digital health solution to the public.

There are still a few conditions in place. These software products still must meet certain quality measures, such as adequate cybersecurity protections, and must be clearly labeled to distinguish between products that have received FDA clearance and those that have not.

Shortly after the FDA rolled out its emergency guidance, McCann said he saw a “tremendous opportunity” for digital therapeutics, and supported the FDA further defining quality standards around this new class of healthcare products.

“I think this is a really good step in the right direction for both access to digital therapeutics and quality standards for digital therapeutics. We’re quite excited about this announcement,” he said in a previous interview.

Another digital health company, Akili, has released a digital therapeutic to the public during this time. Two years ago, the company had submitted results of a pivotal trial of Endeavor, a game intended to approve attention in children with ADHD. Jeff Abraham, vice president of market access and trade, said last week that the company is still actively pursuing 510(k) clearance for the product.

Photo credit: exdez, Getty Images



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