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Click Therapeutics - Model SaMD - Medical Device Software
We are a regulated Software as a Medical Device (SaMD)-focused biotechnology company that develops our applications as medical treatments in accordance with all relevant FDA, ISO and IEC standards.
DEVELOP
We develop prescription software applications as medical devices that work independently or in conjunction with pharmacotherapies to treat disease.
VALIDATE
We clinically validate these applications through rigorous randomized, controlled trials to demonstrate safety and efficacy.
REGISTER
We seek FDA clearance for our apps as class II medical devices with independent therapeutic treatment claims or as adjuncts to existing therapy.
COMMERCIALIZE
Physicians prescribe our apps and payers reimburse for them, while we generate and apply real world evidence to continuously personalize and improve the applications.