Floreo Blog

A Huge Milestone: FloreoRx FDA Submission!

By Heather | Apr 23, 2026

Big news!

We’ve officially submitted a De Novo clearance application to the FDA for FloreoRx, our investigational digital therapeutic designed to improve social skills for children with autism. This milestone is backed by a rigorous clinical trial with 117 children, which found statistically significant outcomes across parent-reported (AIM, CFQL-2) and clinician-administered measures (CARS-2, AFLS).

A few things stand out from the trial:
1) Statistically significant results with just ~18 minutes of VR treatment a week over 12 weeks;
2) The impact for children was higher as the baseline severity of symptoms increased
3) Continued improvement even 60 days after the treatment

Less than four hours of VR not only yielded significant results but also effect sizes that give the therapist superpowers.

We want to thank the families who enrolled in our trial. Your dedication to improve science for the larger autism community is a gift for all. And our partners at Cortica for successfully executing the trial across 18 sites.

We’re eager to continue to engage with leaders across the autism and ABA community. Our CEO, Vijay Ravindran, will be at CASP and the Autism Investor Summit West — and welcomes briefings on the data. The Floreo and Cortica team will be presenting Tuesday evening at CASP.


 

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Just released! Teen Talk: Join a Conversation is here!

Teen Talk: Join A Conversation is designed to help Learners build confidence jumping into real-life conversations. In this lesson, Learners practice identifying the topic and contributing relevant, on-topic comments: key skills for social success.

This lesson may sound familiar: it is a new adaptation of our original Join a Conversation lesson featuring our newly aged-up characters and two difficulty levels. This lesson is designed to meet learners where they are and grow with them. It’s a great way to support more natural, independent communication in everyday interactions.

We've also released some new WIld Immersion content: don't forget to check out Enter a Charming World and Wild Seashores.


Upcoming events


New Partners

We’re excited to welcome our newest Floreo partners!

  • Community Based Services (NY)

And a big congratulations and thank you to Lifeworks Autism Services (OH) who just renewed their program for the next year! We are excited to continue making a difference for their Learners.

If you haven't yet subscribed to Floreo, we would love to chat with you. Reply to this email to speak with a member of our team.

If you are looking for an organization near you that offers Floreo, check out the Floreo Locator!


Using Floreo in your clinic, school, or home

Floreo's Director of Applied Digital Therapy, Rita Solórzano MA, CCC-SLP, is a Speech Language Pathologist with over 30 years of experience.

Impulse control is one of those abilities that often goes unnoticed - until it’s missing. No one is born with it; everyone has to learn it, and sometimes relearn it under different circumstances throughout life. Children develop impulse control at different rates, and some of our learners need significant support in this area. Floreo’s immersive virtual reality lessons can help strengthen these foundational skills.


What have we been reading this week?


About the Author

Heather

Heather is Floreo's Director of Customer Success. She makes sure that all of Floreo's customers are comfortable and confident using Floreo. Prior to working at Floreo, Heather worked at Trove (a news start-up) and eBay for Charity. Heather holds an A.B. from Dartmouth College, where she also played varsity basketball (and won an Ivy League Championship) and a M.Ed. from the University of Mary Washington. In her free time she enjoys reading, tennis, skiing, and hiking around Western North Carolina with her husband, two sons, and adorable lab mix, Pepper.