FDA Approves First Pill with Digital Ingestion Tracking System | Healthcare Informatics Magazine | Health IT | Information Technology Skip to content Skip to navigation

FDA Approves First Pill with Digital Ingestion Tracking System

November 14, 2017
by Heather Landi
| Reprints

The U.S. Food and Drug Administration (FDA) has approved the first drug in the U.S. with a digital ingestion tracking system. Abilify MyCite (aripiprazole tablets with sensor) has an ingestible sensor embedded in the pill that records that the medication was taken.

The product is approved for the treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder and for use as an add-on treatment for depression in adults.

The system works by sending a message from the pill’s sensor to a wearable patch. The patch transmits the information to a mobile application so that patients can track the ingestion of the medication on their smart phone. Patients can also permit their caregivers and physician to access the information through a web-based portal, according to the FDA.

“Being able to track ingestion of medications prescribed for mental illness may be useful for some patients,” Mitchell Mathis, M.D., director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research, said in a statement. “The FDA supports the development and use of new technology in prescription drugs and is committed to working with companies to understand how technology might benefit patients and prescribers.”

The FDA granted the approval of Abilify MyCite to Otsuka Pharmaceutical Co., Ltd. The sensor technology and patch are made by Proteus Digital Health.

About 1 percent of Americans have schizophrenia, a chronic, severe and disabling brain disorder. Typically, symptoms are first seen in adults younger than 30 years of age. Symptoms of those with schizophrenia include hearing voices, believing other people are reading their minds or controlling their thoughts, and being suspicious or withdrawn. Bipolar disorder, also known as manic-depressive illness, is another brain disorder that causes unusual shifts in mood, energy, activity levels and the ability to carry out day-to-day tasks. The symptoms of bipolar disorder include alternating periods of depression and high or irritable mood, increased activity and restlessness, racing thoughts, talking fast, impulsive behavior and a decreased need for sleep.

Get the latest information on Health IT and attend other valuable sessions at this two-day Summit providing healthcare leaders with educational content, insightful debate and dialogue on the future of healthcare and technology.

Learn More



Arizona ACO Pilots Blockchain Platform to Improve Clinical Outcomes, Reduce Costs

Arizona Care Network, a Phoenix-based accountable care organization (ACO), plans to pilot a blockchain technology platform developed by Solve.Care with the aim of improving clinical outcomes, relieving healthcare’s administrative burdens, and reducing waste within the system.

Protenus February Breach Report: Number of Incidents Remain Steady

The number of healthcare data breach incidents continues to remain steady, and in February’s Breach Barometer report from Protenus, it was revealed that last month, a ransomware attack was responsible for the largest single incident.

Prior Authorization Burdens Hindering Patient Care, AMA Survey Finds

Approximately 64 percent of physicians in a recent American Medical Association (AMA) survey said they wait at least one business day before getting a response from a health plan regarding a prior authorization (PA) decision.

Intermountain Healthcare to Build Global DNA Registry with AncestryDNA, 23andMe Data

Intermountain Healthcare is building a new global DNA registry based on medical histories from people around the world, using existing genetic test results and electronic health histories.

NH-ISAC Accelerates Cyber Threat Sharing for Healthcare Industry

The National Health Information Sharing and Analysis Center (NH-ISAC) is partnering with Anomali, a provider of threat management solutions, to enable seamless, secure threat sharing within the healthcare community.

Enterprise Telemedicine Strategies Gaining Steam, Survey Finds

Healthcare providers are increasingly leveraging a centrally-managed (enterprise) approach to telemedicine, according to the results of the REACH Health 2018 U.S. Telemedicine Industry Benchmark survey.