Inside the Digital Therapeutics Approval Pipeline

Lucas and Luna break down how digital therapeutics actually get approved. Using Pear Therapeutics' reSET-O as a case study, they walk through the FDA's new Software Precertification Pilot, the difference between a wellness app and a regulated digital therapeutic, and why the failure rate for DTx submissions is still above 60 percent. They also explore how companies like Akili Interactive and Big Health are navigating the evidence bar. If you're building in health tech, this episode gives you the regulatory roadmap that most founders get wrong. #DigitalTherapeutics #FDAApproval #PearTherapeutics #reSETO #AkiliInteractive #BigHealth #SoftwarePrecertification #RegulatoryScience #HealthTech #DTx #Business #Technology #HealthcareInnovation #ClinicalTrials #EvidenceBar #FexingoBusiness #BusinessPodcast #TheDigitalHealthPodcast Keep every episode free: buymeacoffee.com/fexingo