Once it reaches the stomach, the sensor collects information on timing of digestion and sends a signal via the patient's body tissue to a patch worn on the skin, which also collects heart rate and activity data. All that information is relayed to a mobile phone application and can be accessible to doctors and clinicians to monitor patient behavior and ensure they are taking pharmaceuticals correctly.
In an order to be published in the Federal Register on Thursday, the FDA is amending the Federal Food, Drug, and Cosmetic Act, which gives the agency regulatory authority, to categorize the technology, formally known as an ingestible event marker, as a class 2 medical device. Class 2 is less restrictive than class 3, the status that new devices are normally automatically given at first.
FDA granted the device class 2 status shortly after its approval in 2012, but the legal order sets a permanent standard for the technology.
The company claims the device can help patients "to develop and sustain healthy habits, families to make better health choices, and clinicians to provide more effective, data-driven care."
The firm recently raised $62.5 million from a variety of corporate investors, including Novartis and Oracle, to continue work on pharmaceuticals that contain tiny transmitting sensors.
-- The story was updated at 9:27 p.m. to clarify when the device was classified as class 2.