Today, the U.S. Food and Drug Administration announced it is launching the Digital Health Center of Excellence within the Center for Devices and Radiological Health (CDRH). The launch of the Digital Health Center of Excellence is an important step in furthering the agency's overarching dedication to the advancement of digital health technology, including mobile health devices, Software as a Medical Device (SaMD), wearables when used as a medical device, and technologies used to study medical products.
Siemens Healthineers announced today a master collaboration agreement with Novartis Pharma AG to design, develop, and commercialize diagnostic tests for therapeutic products across Novartis' therapeutic pipeline. The initial program supports the development of a serum neurofilament light chain (sNFL) immunoassay to support Novartis’ MS and other neuroscience programs.
An innovative health technology company, that has seen its secure mobile communications app scale rapidly in the NHS during the coronavirus pandemic, is expanding its multi-platform solution to pharmacy networks and GP practices to improve the coordination of important communication and prescribing information between healthcare professionals and patients. BioEP works by creating mathematical models of the brain using short segments of electroencephalogram (EEG) recordings.
South London and Maudsley NHS Foundation Trust is using the Oxehealth Digital Care Assistant in the seclusion suite of Eileen Skellern 1 ward.
The women's ward has a tradition of improving the therapeutic environment and is using the Digital Care Assistant to support clinical staff to monitor the safety and physical health of patients when they are unwell.
Fitbit (NYSE:FIT) has received 510(k) clearance from the U.S. Food and Drug Administration (FDA), as well as Conformité Européenne (CE) marking in the European Union, for its electrocardiogram (ECG) app to assess heart rhythm for atrial fibrillation (AFib), a condition that affects more than 33.5 million people globally.
Cerner Corporation is pleased to announce a new relationship with Hampshire and Isle of Wight (HIOW) health and care system to enable their population health management journey to transform the planning and delivery of health and care services across the region.
The initiative will see the implementation of Cerner’s population health management data platform, HealtheIntent ®, alongside HealtheEDW SM, a big data analytics solution.