FDA Commissioner Scott Gottlieb trumpeted the agency’s “modern and flexible” approach to digital health regulation when speaking at Health Datapalooza last week. As we have written about here, FDA has announced multiple initiatives over the last several months designed to clarify the regulatory considerations around new and emerging digital health technologies. Last week’s speech continued … Continue Reading
FDA announced last week that it is permitting marketing of an mHealth app that uses artificial intelligence (AI) to analyze CT images for signs of stroke. The app, called Contact, is a clinical decision support tool marketed by Viz.AI. It relies on triage software to scan for potential blockages and then notifies a medical specialist … Continue Reading
Last week, FDA released a document outlining its policy priorities for the coming year. “Healthy Innovation, Safer Families: FDA’s 2018 Strategic Roadmap” addresses continued focus on digital health, among other priorities, as one way that the agency seeks to further its public health mission and foster innovation that benefits consumers and patients. Consistent with this … Continue Reading
The “Internet of Medical Things Resiliency Partnership Act of 2017” was introduced in the House of Representative earlier this month. Co-sponsored by Rep. David Trott (R-MI) and Rep. Susan Brooks (R-IN), the bill would require establishment of “a working group of public and private entities to develop recommendations for voluntary frameworks and guidelines to increase … Continue Reading
In his keynote address at the AdvaMed annual conference in late September, FDA Commissioner Scott Gottlieb returned to the themes of promoting innovation by partnering with industry. Consistent with that, and furthering the agency’s emphasis on digital health innovation, he announced the companies that will be participating in FDA’s Pre-Cert program, a program that the … Continue Reading
