“Digital therapeutics need to meet the demands for efficacy and safety set by regulatory stakeholders,” says Acacia. “I’ve been consistently impressed by Soihtu DTx’s commitment to rigorous clinical evidence, which establishes a strong foundation for regulatory approval. And as a bonus, they’re an absolute joy to work with!”
We are equally excited to collaborate with Acacia! She brings a rare blend of deep scientific insight and regulatory strategy expertise, with a proven track record guiding digital health innovations through complex regulatory and reimbursement pathways. Her experience is already accelerating our mission.
Together, we are building a robust clinical evidence package to meet the highest standards in healthcare and advancing towards the FDA’s 510(k) premarket notification. Our collaboration has already gained strong momentum, and we’re just getting started.
