Regulation
The AI tool can now be used to triage radiology scans with intracranial bleeds, mass effect, midline shift, and cranial fractures.
The device monitors vitals from up to four feet away, and is designed for use in healthcare settings or at home.
The long-awaited decision is the first regulatory authorization for Akili, and the first game-based therapeutic that the FDA has greenlit for any condition.
The system is able to continuously transmit glucose data every minute.
The company also announced its plans to launch Lumify, a handheld ultrasound device, in Japan.
Eko's ECG low ejection fraction tool will now be able to help clinicians spot cardiac complications associated with the novel coronavirus.
Technology issues for interoperability are more of a cultural than a deployment challenge, explain Drew Ivan, Lyniate's chief product and strategy officer, and Matthew Michela, CEO of Life Image.
This news means that the Australian company will be able to expand to the United States.
The continuous remote monitor can help prevent complications driven by experimental COVID-19 treatments such as hydroxychloroquine or chloroquine, according to the agency.
Dr. Don Rucker, National Coordinator for Health Information Technology Office of the National Coordinator for Health IT, discusses his work with the Global Digital Health Partnership initative.