Novartis AG plans to seek regulatory approval within 18 months for a pioneering tablet containing an embedded microchip, bringing the concept of smart-pill" technology a step closer. The initial program will use one of the Swiss firm's established drugs taken by transplant patients to avoid organ rejection. But Trevor Mundel, global head of development, believes the concept can be applied to many other pills. Novartis agreed in January to spend $24 million to secure access to chip-in-a-pill technology developed by privately owned Proteus Biomedical of Redwood City, California, putting it ahead of rivals. The biotech start-up's ingestible chips are activated by stomach acid and send information to a small patch worn on the patient's skin, which can transmit data to a smartphone or send it over the Internet to a doctor. Because the tiny chips are added to existing drugs, Novartis does not expect to have to conduct full-scale clinical trials to prove the new products work. Instead, it aims to do so-called bioequivalence tests to show they are the same as the original. A bigger issue may be what checks should be put in place to protect patients' personal medical data as it is transmitted from inside their bodies by wireless and Bluetooth.
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