Novartis will seek regulatory approval for 'smart pill'

Donna Cusano

Not at the mHealth Summit either:  Novartis expects within 18 months to go for regulatory approval–probably European first–of the Proteus Biomedical chip-implanted ‘smart pill’. Trevor Mundel, Novartis global head of development, announced at the Reuters Health Summit in New York today that the first pharmaceutical submitted for approval will be a transplant anti-rejection drug, as compliance is most critical for the condition.  According to the article, full scale clinical trials will not be needed, only bioequivalence.  Proteus already has CE approval for the chip and biometric body sensor that transmits the signal to a smartphone or internet [TA 17 Aug].  Reuters, ‘Look out, your medicine is watching you.’ (a headline we could have done without–‘Frankenpills’ anyone?)