Digital therapies are proving particularly useful in pathological conditions linked to behavioural and psychological factors, such as Alzheimer’s, dementia, type II diabetes, and even serious respiratory problems. Let’s take a look at how they are made, how they work, the indications and market perspectives.
The FDA has awarded De Novo certification to NigthWare which has developed a digital therapy to combat sleep disorders.
The FDA has authorized Abbott to market the BinaxNOW COVID-19 Ag CARD, a kit for the rapid diagnosis of Covid-19 through a nasal swab, for emergency use (EUA).
Akili Interactive has received De Novo marketing authorization from the FDA for EndeavorRx, a therapeutic video game for children aged 8-12 years with ADHD (Attention Deficit Disorder/Hyperactivity Disorder).
FDA has published a 20-page white paper on how to set up certification as a medical device of machine-learning software (SaMD). Continue reading
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