Regulation
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.
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 health app evaluation and advisor organisation will provide Sigma with review and accreditation services to advance its digital health apps.
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.