The US Food and Drug Administration (#FDA) has cautiously moved to embrace Digital Therapeutics, mobile trial platforms and expanded use of real world evidence (#RWE) mining for clinical development: this progress will continue to drive sponsor investment.
Substantively, the agency has issued landmark approvals of digital products including Pear’s reSET, Proteus/Otsuka’s Abilify MyCite, and earlier WellDoc’s BlueStar.
The list of companies with digital products in development that will be seeking approval is growing.
This non-invasive brain training solution uses an electroencephalogram (EEG) measurement device + Personalized brain exercises on an app. URGONight, the first non-invasive daytime brain training solution for a better sleep, is named as a CES 2019 Innovation Award Nominee in the Wearable Technology category.
How Does the Neurofeedback Method Work?
Developed by neuroscientists and sleep experts, URGONight uses the same technology previously only available to clinics and sleep researchers. Now, EEG-feedback therapy for sleep is available in the comfort of your own home.
Using exclusively bio-compatible and bio-degradable materials, researchers from the University of Stanford have devised a capacitive-based artery blood-flow sensor which can be read out wirelessly once implanted, and which does not require removal as it self-resorbs after a few months of operation.
The thin flexible device described in a paper titled “Biodegradable and flexible arterial-pulse sensor for the wireless monitoring of blood flow” published in Nature Biomedical Engineering was designed to locally monitor blood flow after complex reconstructive surgeries involving “anastomosis”, the suturing of blood vessels, such as would be the case in cardiovascular, vascular and transplantation operations.