FDA Approves Digital Pill
Could new medical technology help people with chronic pain get consistent relief? That’s what manufacturer Proteus Digital Health, Inc is hoping. The company is moving forward with its ingestible sensor for marketing as a medical device, after the U.S. Food and Drug Administration (FDA) gave the green light earlier this month.
I am thinking it would be a great help for those who care for the elderly to be able to know when and how much medication has been taken. Doctors can even tell if the patient has missed a dose, and make the necessary adjustments. The ingestible sensor is part of the Proteus digital health feedback system, an integrated, end-to-end personal health management system that is designed to help improve patients’ health habits and connections to caregivers.
The FDA has been working with Proteus for the past four years to pave the regulatory path for this innovation, which represents a new category of medical device and patient care.
The way it works is quite interesting. Once the ingestible sensor reaches the patient’s stomach acid, it sends a unique signal through the user’s body tissue to a patch worn on the skin that detects the signal and marks the precise time the meds were taken. (This patch can also collect data on heart rate, body position and activity!) The patch then sends information to a mobile phone app, which can then be accessible by caregivers and doctors anywhere in the world.
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- FDA clears the “smart pill” by Proteus Digital Health (ingestible sensor) (medicineandtechnology.com)
- FDA Approves Ingestible Sensor That Tracks Health From The Inside (medicalnewstoday.com)
- FDA approves ‘ingestible sensor’ for use as a medical device (slashgear.com)
- FDA Approves the Ingestible Smart Pill “ChipSkin” – Part of the Proteus Wireless Monitoring System that Currently Uses Patches For Heart Rate Monitoring (ducknetweb.blogspot.com)
- FDA approves ingestible sensor that transmits patient data to doctors (cbsnews.com)
- A Medical Sensor You Can Swallow (spectrum.ieee.org)