A growing number of startups are turning to the Food and Drug Administration (FDA) to validate innovative interventions for autism spectrum disorder (ASD) that go beyond traditional behavior therapy. These companies are pushing the boundaries of how autism is diagnosed and treated by applying the rigorous standards required for FDA clearance for autism devices—an emerging trend reshaping the autism care landscape.
For years, the autism treatment field has leaned heavily on behavioral therapies. While beneficial, these methods can be time-consuming, expensive, and subjective. The path to FDA clearance for autism devices offers a way to introduce more standardized, evidence-based approaches, helping address long-standing gaps in access, diagnostic accuracy, and treatment outcomes.
Why companies are turning to the FDA
The FDA clearance process is known for being lengthy and expensive. A recent survey of device companies revealed that the median cost of obtaining FDA clearance for autism devices is around $6.1 million—with some spending as much as $41 million. Yet many startups see the process not as a barrier, but as a necessary step toward credibility and ethical responsibility.
Katya Sverdlov, CEO of JelikaLite Corp., described her company’s journey through the FDA as one grounded in integrity. JelikaLite’s Cognilum platform uses transcranial photobiomodulation—infrared light targeted at the cerebellum—to stimulate mitochondrial function in the brain. The company hopes this novel approach can aid in managing certain autism symptoms. “We didn’t want to give families false hope with treatments that haven’t been validated,” Sverdlov said. “Going after FDA clearance for autism devices is our way of proving this works.”
Building trust with clinicians and stakeholders
Clinicians serve as the primary access point between patients and emerging autism technologies. Without their buy-in, it’s difficult for new tools to reach those who need them most. Experts say FDA clearance for autism devices is often the first thing clinicians look for when evaluating whether to adopt a new intervention.
Michael Fox, VP of Marketing at EarliTec Diagnostics, emphasized this in a recent interview. EarliTec has received two FDA clearances for its eye-tracking diagnostic tools aimed at streamlining autism assessment. “FDA clearance for autism devices not only ensures regulatory compliance but also builds trust among clinicians, investors, and payers,” Fox explained.
Sharief Taraman, CEO of Cognoa, echoed this sentiment. Cognoa’s digital platform, Canvas Dx, helps clinicians diagnose autism more quickly and objectively. After receiving FDA clearance for autism devices in 2021, the company secured reimbursement deals and grew provider adoption. “With FDA validation, clinicians know our platform is safe, effective, and backed by science,” Taraman said.
Unlocking reimbursement and scaling innovation
One of the most important reasons for companies to pursue FDA clearance for autism devices is access to reimbursement. Without FDA approval, insurers are unlikely to cover a device, placing the financial burden on families or healthcare providers. Even providers eager to adopt new tools may hesitate without a path to payment.
Taraman noted that early diagnosis through FDA-cleared tools could save families an estimated $2.5 million in lifetime care costs. Cognoa’s partnership with Highmark, one of the nation’s largest insurers, led to coverage for Canvas Dx without prior authorization. “This is the kind of economic validation we need to expand access,” Taraman said.
Vijay Ravindran, CEO of Floreo Inc., is also banking on FDA approval to scale. Floreo develops a virtual reality (VR) platform for autism therapy, creating immersive experiences to help children build real-world skills. “If we want to serve the million-plus children who could benefit from VR, FDA clearance for autism devices is essential,” Ravindran said.
Bridging innovation with reimbursement pathways
Floreo’s pursuit of regulatory legitimacy recently led to its inclusion in the FDA’s Total Product Life Cycle Advisory Program and designation as a breakthrough device. These programs are designed to speed up FDA clearance for autism devices that show promise in treating or diagnosing serious conditions.
In parallel, Floreo worked with the American Medical Association to introduce new CPT codes for VR-based therapy. While CPT codes don’t guarantee reimbursement, they lay the foundation for future billing standards. Ravindran said the “north star” is to obtain a CPT I code—which typically requires full FDA market authorization.
“Having FDA clearance for autism devices is the only way to create a clear reimbursement pathway that providers can trust and use,” Ravindran explained. “It’s not just about building technology—it’s about making sure it actually gets to kids who need it.”
The future of FDA-cleared autism innovation
As autism diagnosis and treatment grow in complexity, the demand for validated, scalable solutions increases. Behavioral therapies remain essential, but they can’t stand alone in a system struggling to meet growing needs. Startups that pursue FDA clearance for autism devices are betting on a future where early diagnosis, precise assessment, and tailored treatments are more accessible—and reimbursable.
FDA approval opens the door to more than market access. It signals to clinicians, families, and payers that a product is backed by data, ethically developed, and designed to improve lives. From diagnostic tools to therapeutic VR platforms, FDA clearance for an autism device is quickly becoming the gold standard for innovation in autism care.
