FDA
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.
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.
The platform aims to support patients with respiratory conditions and enables clinical decision making amongst respiratory health professionals.
While its Galaxy Watch3 device is available now, a launch date for the Samsung Health Monitor app that will enable ECG, blood pressure and blood oxygen saturation tracking is still up in the air.
The FDA now allows LabCorp's platform to test patients with no COVID-19 symptoms, or to run samples from up to five patients at a time.
The Patient Controller app works with Abbott's Infinity DBS System, Proclaim XR SCS System and Proclaim DRG Neurostimulation System.
The information is stored and sent to hospital systems and the Vitls app, so healthcare providers can monitor the vital signs of their patients in real time, no matter where they are.