NOVEMBER 2018 – Software as a Medical Device

Join us for our kickoff event for the HealthTech Boston group of Mobile Monday Boston.

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 (Akili Interactive), Greg Stern (Sanofi), Jeremy Gilbert (Pear Therapeutics), and Carlos Rodarte (Volar Health) about the latest developments in digital therapeutics and Software as a Medical Device (SaMD).

Event details:
November 14th, 2018
WPI Seaport @ 303 Congress Street, Boston, MA

Register

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