Next year, some family physicians likely will be using ingestible digital pills to keep track of patient's health, the New York Times' "Bits" reports (Bilton, "Bits", New York Times, 6/23).
Such pills feature an embedded microchip to transmit patient data to health care providers.
Last month, FDA said that it is easing federal oversight of the pills.
FDA said it is amending the Federal Food, Drug and Cosmetic Act -- which gives the agency regulatory authority -- to categorize digital pill technology as a class 2 medical device. Traditionally, new devices are automatically labeled as class 3 devices, which is more restrictive than class 2.
In July 2012, FDA approved Proteus Digital Health's microchip, a silicon wafer that is embedded in an ingestible pill.
The device generates electricity when it makes contact with the stomach's digestive fluids and sends a signal to a patch on the patient's skin.
The disposable patch then can transmit information to a health care provider's mobile phone application, including data on:
- Time the pill is taken;
- Heart rate;
- Body position; and
- Temperature (iHealthBeat, 5/16).
Other Digital Pills
In addition to Proteus' digital pill technology, HQ -- a Florida company -- has developed a pill that has a built-in battery and sends real-time body temperature updates as it moves through a patient's body.
Meanwhile, Regina Dugan -- senior vice president for Motorola Mobility's advanced technology and projects group -- at a digital technology conference last month showed an example of a digital pill that can wirelessly communicate with a smartphone application ("Bits", New York Times