One year after the FDA declined to approve Proteus Digital Health and Otsuka's new sensor-embedded formulation of Otsuka's antipsychotic drug Abilify, the companies are giving it another shot, resubmitting the application with additional information. As before, the application is a New Drug Application (NDA) -- both the Proteus system itself and Abilify are already FDA cleared and approved,...
When Proteus Digital Health got its first FDA clearance, Stephen Colbert, then still the host of The Colbert Report, featured the pill on his ‘Cheating Death’ segment.
“The sensor can help patients suffering from diseases of the central nervous center, including schizophrenia,” he said. “Because nothing is more reassuring to a schizophrenic than a corporation inserting sensors into your body that...
Redwood City, California-based Proteus Digital Health announced its first US healthcare provider customer, Barton Health, which will prescribe the company's Proteus Discover to patients. The company says this is the first time its technology has been implemented outside of a clinical trial setting in the US.
Barton Health, a health system in Lake Tahoe, California, will use the medication...
