PILOTING A PATH FOR DIGITAL INNOVATION
Tidepool , comments : “ This is the FDA acknowledging the old guidance for how software technology is regulated wasn ’ t working , and couldn ’ t keep up with the pace of innovation we ’ ve been seeing in Silicon Valley and the consumer world .”
“ We commend the FDA ’ s Digital Health Innovation Action Plan initiative and the speed with which they are moving towards building a regulatory pathway to bring these important products to patients ,” says Corey McCann , President and CEO at Pear Therapeutics , which completes the list of nine participants . Pear Therapeutics is a leader in prescription digital therapeutics which integrate clinicallyvalidated software applications with previously approved pharmaceuticals and treatments to provide better outcomes for patients and smarter engagement / tracking tools for clinicians . Pear ’ s lead product , reSET ®, is an FDA-cleared , 12-week interval prescription therapeutic for Substance Use Disorder , designed to be used alongside standard outpatient treatment .
Dr Marisa Miraldo is an Associate Professor in Health Economics at Imperial College Business School , and
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