FDA
Bradley Merrill Thompson, an FDA-watcher, lawyer and occasional MobiHealthNews guest contributor, joins the MobiHealthNews team for a closer look at what the FDA has been up to around digital health and AI.
Dascena's COViage system uses demographic and vital-sign data pulled from a COVID-19 patients' EHR to calculate their risk of hemodynamic instability or respiratory failure.
The company said that its tool was "highly accurate" in a 425-participant study conducted across 14 U.S. sites.
Although still a work in progress, the new center will reportedly help coordinate digital health projects within the agency while providing expertise to external stakeholders.
Panelists at DTx East discuss the difference between 510(k) clearances and enforcement discretions, and why research should go beyond the FDA threshold.
Dr. Amy Abernethy, principal deputy commissioner at the U.S. FDA, discusses the FDA's role in balancing innovation, regulation and safety during the coronavirus pandemic.
The new tool can monitor a patient's end-tidal carbon dioxide, respiratory rate, and fractional inspired CO2.
Masimo's O3 Regional Oximeter can be integrated with its SedLine brain function monitor or its Root patient monitoring and connectivity platform.
The consumer genomics company's existing offering, called AncestryHealth, sold clinician-ordered tests that were not cleared or approved by the FDA.
While the company's new 510(k) cuts down some of the burden, consumers are still advised to consult their healthcare provider before making any changes to their treatments.