Regulation
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.
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.
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.
The device was originally developed at MIT with Harvard Medical School.
The aim of the electronic system is to ensure medicines are dispensed according to the correct procedures set by authorities, as well as to prevent counterfeit drugs.