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A new era for digital therapeutics:
Medical treatments that incorporate software running on patient’s personal devices are starting to gain widespread acceptance. Several new companies are building treatment pipelines of mobile apps that can be prescribed and reimbursed by insurance. Meanwhile the pharmaceutical industry is producing a steady stream of companion apps that can integrate with devices in the home for drug delivery and data collection.
The FDA and Software as a Medical Device (SaMD):
The medical community and FDA are responding favorably to this trend. Earlier this year, the FDA rolled out a pre-certification program for software as a medical device to address the needs of software developers who typically operate at a timescale of weeks instead of years. In their words, an “agile regulatory paradigm is necessary to accommodate the faster rate of development and potential for innovation in software-based products.”
Join us for an open discussion with Ashley Mateus from Akili Therapeutics, Greg Stern from Sanofi and other experts about the latest developments in digital therapeutics and Software as a Medical Device (SaMD).
About HealthTech Boston
HealthTech Boston is a new group of technology experts and medical professionals who are passionate about healthcare. While Boston is both a world leader in healthcare and home to a thriving technology ecosystem, these two communities interact less often than they should. HealthTech Boston will bridge that gap by helping tech experts to enter the complex healthcare sector and provide technical assistance to our local academic medical centers, biotech companies, and healthcare entrepreneurs.