Ingestible Smart Pills Cleared By FDA to Improve Medication Adherence

  • Posted on: Wed, 10/21/2015 - 22:42
  • By: OCHIS
Recently, the FDA has expanded the indications for the latest ingestible sensor technology, enabling the device to be used as an aid in the measurement of medication adherence. 

Proteus Ingestible Sensor, which combines ingestible, mobile, wearable and cloud computing, become the first device measuring medication adherence with an FDA-sanctioned claim. As it is used with the medication monitoring, the Proteus Ingestible Sensor can mark actual intake time and record the time of ingestion along with different physiological parameters such as steps, rest and heart rate. The sensor communicates the actual time to an adhesive patch (The Proteus Patch) that links to a mobile app via Bluetooth. Only permitted people, such as family and health care providers, will be able to see the confidential information via an encrypted website.

Medication non-adherence is a significant public health consideration that greatly influence health outcomes and overall health care costs. Increasing adherence in patients with higher acuity is being considered as an investment, especially when the rate of hospitalization is high. To prevent admissions and readmissions, hospitals and payers have launched programs to improve medication adherence after discharge. Traditionally, improved adherence can be achieved through better education, value-based insurance designs, and thoughtful use of patient incentives. Now we have a new alternative.

Using the new technology, Proteus is creating a new category of therapy: Digital Medicines. In its vision, Digital Medicine therapy includes drugs that could self report the time they’ve been taken and sensors that would record the physiological response. This might help patient in self-care, physician in dosage follow up, and data analytics in interpreting patient health status, which will effectively manage medication-taking behavior and physiologic response to therapy. It also allow better insights for patients' health habits and more personalized medicine.

Depending on the pharmacy’s capabilities and the doctor’s prescription, the ingestible sensor can be dispensed in following ways:

  1. Using a stand-alone packaging and 1 sensor-enabled inactive tablet will be ingested every time when the patients take their prescribed active medication.

  2. Packaged in specialty blister packets or sachets and 1 sensor-enabled inactive tablet is dispensed with 1 dose of the prescribed active medication.

  3. Inside a capsules that has a sensor-enabled inactive tablet and the prescribed active medication.



[2] Iuga, A. O., & McGuire, M. J. (2014). Adherence and health care costs. Risk management and healthcare policy, 7, 35.

[3] Pictures: