Regulation
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.
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.
The new tool can monitor a patient's end-tidal carbon dioxide, respiratory rate, and fractional inspired CO2.
The ECG app can detect over 98% of atrial fibrillation cases and was 100% accurate in identifying participants with normal sinus rhythm, according to study results.
The UK government has released a proposed regime on the regulation of medical devices in Great Britain, Northern Ireland and the European Union post Brexit.
This marks the first automated delivery system that can be used for children 2 to 6.
Masimo's O3 Regional Oximeter can be integrated with its SedLine brain function monitor or its Root patient monitoring and connectivity platform.
The product consists of three components - a patient app, a doctor app, and a portable CO Checker.
The consumer genomics company's existing offering, called AncestryHealth, sold clinician-ordered tests that were not cleared or approved by the FDA.