From streamlining long-held manual processes to creating entirely new diagnostic devices, new tech is cropping up all over the medtech industry—resulting in a real-world impact on patients' quality of life.
Huma plays a vital role in leveraging its digital infrastructure to help medical device companies navigate the regulatory complexities of generating RWE.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
An upcoming webinar sponsored by Huma will highlight three aspects of remote monitoring: real world data collection, supercharging patient engagement and navigating the regulatory landscape. Register today!
A new report from the Duke University Margolis Center for Health seeks to shed light on the current state of AI technology in healthcare and how to effectively drive adoption of AI-based clinical support tools.
A range of companies at the Digital Health showcase in San Francisco discussed how they view the changing regulatory environment within the category of software as a medical device.
The main reason for the latest publications on SaMDs by both the FDA and International Medical Device Regulators Forum is to bridge regulatory gaps that have resulted from the proliferation of app development and smartphone usage.
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.