AI is reshaping healthcare—but for innovators building AI/ML-enabled software as a medical device (SaMD), staying compliant with FDA regulations is just as critical as building great tech. The FDA’s evolving Total Product Lifecycle (TPLC) approach, new transparency principles, and guidance on Predetermined Change Control Plans (PCCPs) are reshaping the path to market.
Read MoreScaling a healthcare AI company? Learn the top legal strategies for growth-stage digital health companies—from FDA SaMD analysis and HIPAA compliance to state AI laws and AI governance.
Read MoreHealthcare delivery is changing, and digital health is revolutionizing healthcare, creating a burgeoning market opportunity for software-as-a-medical-device (SaMD) and digital therapeutic (DTx) products.
Read MoreFind out what Healthcare and Life Sciences businesses and investors anticipate for the healthcare industry in 2022.
Read MoreWith these new RTM codes set to go into effect January 1, 2022, RPM vendors already in the remote monitoring arena should start preparing now for how they can take advantage of this new reimbursement opportunity.
Read MoreIf you’re in the Remote Patient Monitoring (RPM) or Remote Therapeutic Monitoring (RTM) space, then you’ll want to understand the criteria and opportunities for qualifying as Software as a Medical Device (SaMD)
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