FDA Gives Thumbs-up to EtectRx's Wireless Smart Pills

Approved

The U.S. Food and Drug Administration (FDA) approved Gainesville, Florida-based etectRx’s ID-CAP System. The company calls the system the first and only “ingestible event marker to transmit digital messages” from inside the body to a receiver without need for direct skin contact. In other words, the ID-CAP System is a pill loaded with sensors that wirelessly communicates to a system outside the body without physical contact. The purpose appears to, at least initially, confirm that the patient actually took the medication.

The system is made up of the ID-Capsule, ID-Tag, ID-Cap Reader and the associated software. It provides real-time, dose-level data on when the pill is ingested. The ID-Capsule is a regular pharmaceutical capsule that contains the ID-Tag, which is an ingestible sensor. The ID-Tag produces a low-power digital message that is activated by the patient’s stomach fluid. The ID-Cap Reader is worn on a lanyard and it verifies the message as a valid ingestion event, forwarding the data to a secure smartphone-based mobile app and to the healthcare provider via a secure web-based portal.

“This is a historic event for etectRx and the larger digital health market,” said Harry J. Travis, president and chief executive officer of etectRx. “It is the first product enabled by our proprietary in-vivo communication technology platform to gain clearance. We are very excited about the many opportunities that the ID-Cap System will provide patients and clinicians to improve therapeutic outcomes and deliver better care.”

The FDA classified the system as an ingestible event marker and Class II medical device. It will be available by prescription.

etectRx has also partnered with researchers at Brigham and Women’s Hospital and Fenway Health to study the system in HIV medications.

The company hasn’t indicated which types of medications it will work with and remains slightly ambiguous about what the practical applications are, although Travis indicates that he is encouraged by early conversations he’s held with pharmaceutical companies. Adherence and compliance appear to be the early reason for use, since it’s a clear market with published research. A 2005 study in the New England Journal of Medicine found that patients don’t take their medications up to 50% of the time. And, of course, pharma companies want physicians to actually fill and refill their prescriptions.

The system was approved through the FDA’s 510(k) clearance, which allows for quicker approval for device makers by comparing their product to one currently on the market. In the case of etectRx’s system, it was compared to Proteus’ sensors. However, one big difference is that with Proteus’ technology, patients wear a patch instead of a lanyard.

One issue that the market has struggled with is consumer trust and costs. Proteus’ Abilify MyCite runs about $1,650 per month. Some patients have expressed concern over privacy issues.

Travis argues that they will focus entirely on medication adherence. Because patients can take off the lanyard, the privacy issues may be less of a factor.

“There are differences between the products,” Travis told MedCity News. “It’s important to look at each therapeutic category to understand what the barriers are. Patients will ask, what’s in it for me? Why do you want me to take this monitored medication?”

It may have less to do with patients than insurers, however. It’s possible payers may offer incentives and discounts to consumers on their deductible for using the systems, although the cost-benefits analysis of that would likely be complex.

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