Proteus Ingestible Sensor for Tracking Medication Intake Receives FDA Clearance

Proteus Ingestible Sensor for Tracking Medication Intake Receives FDA Clearance

Proteus Digital Health Announces FDA Clearance of Ingestible Sensor

REDWOOD CITY, Calif. – July 30, 2012 – Proteus Digital Health, Inc. announced today that the U.S. Food and Drug Administration (FDA) has cleared its ingestible sensor for marketing as a medical device. The ingestible sensor (formally referred to as the Ingestion Event Marker or IEM) 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.

Proteus has worked collaboratively with the FDA since 2008 to determine the regulatory pathway for this innovation, which represents a new category of medical device and patient care. The application was ultimately processed in accordance with the de novo provisions of the Federal Food, Drug and Cosmetic Act for low-risk devices that have no predicate on the market.

“We are thrilled to have achieved this important milestone to market our ingestible sensor in the United States now, as well as in Europe,” said Dr. George M. Savage, co-founder and chief medical officer at Proteus Digital Health. “We are very much looking forward to bringing the benefits of our ingestible sensor to the American public in the form of innovative product offerings.”

“The FDA validation represents a major milestone in digital medicine. Directly digitizing pills, for the first time, in conjunction with our wireless infrastructure, may prove to be the new standard for influencing medication adherence and significantly aid chronic disease management,” said Dr. Eric Topol, professor of genomics at The Scripps Research Institute and author of “The Creative Destruction of Medicine: How the Digital Revolution Will Create Better Healthcare”.

The Proteus ingestible sensor can be integrated into an inert pill or other ingested products, such as pharmaceuticals. Once the ingestible sensor reaches the stomach, it is powered by contact with stomach fluid and communicates a unique signal that determines identity and timing of ingestion. This information is transferred through the user’s body tissue to a patch worn on the skin that detects the signal and marks the precise time an ingestible sensor has been taken. Additional physiologic and behavioral metrics collected by the patch include heart rate, body position and activity. The patch relays information to a mobile phone application. With the patient’s consent, the information is accessible by caregivers and clinicians, helping individuals to develop and sustain healthy habits, families to make better health choices, and clinicians to provide more effective, data-driven care.

About Proteus Digital Health

Proteus Digital Health, Inc. is developing and commercializing digital health feedback technology that is integrated into ingestible products. This provides an unprecedented view into an individual’s personal health choices and physiologic response, allowing patients to better manage their health and more effectively collaborate with caregivers and clinicians, while enabling new information-based business models. Proteus received a CE mark in August 2010 and U.S. FDA approval in July 2012 for its technology platform. Headquartered in Redwood City, Calif., Proteus is privately held and funded by Carlyle, Essex Woodlands, Kaiser Permanente, Medtronic,

Proteus Biomedical has received CE Mark approval from the European Union to bring to market the firm’s Raisin ingestible drug sensors and monitoring system. baquh04l Proteus Pill Ingestion Monitoring System Gets EU Green LightWhen a patient swallows tablets that have individually tagged beacons on them, a sensor can automatically record the precise time and basic vital signs of the patient at that time. The system allows physicians to get a better picture of how a patient responds to a given medication. The system received FDA regulatory approval back in April. Additionally MobiHealthNews is reporting that UK’s National Health Service will be testing the system in a trial involving 40 patients over four months.

Proteus’s ingestible sensor and personal monitor system, called the RaisinTM System, is indicated under the CE Mark to timestamp, via ingestion, any discrete event (such as the ingestion of a specific pharmaceutical) and to record this event along with physiologic information such as heart rate, activity, body angle and patient-logged information. The unique ingestion event and personalized physiologic information are then communicated via Bluetooth to any computerized device, such as a mobile phone for emerging mHealth applications.

The Raisin System is being developed as part of Proteus’s integrated intelligent medicine system to link sensor-based formulations of pharmaceutical products to individualized physiologic response and outcomes-based treatment systems. Proteus and its partners are currently developing these integrated product systems in diabetes, cardiovascular disease, psychiatric disorders, organ transplantation and infectious disease.

Proteus Digital Health has received FDA clearance for its ingestible sensor. The sensor (formally referred to as the Ingestion Event Marker or IEM) is part of the Proteus digital health feedback system, which also includes a wireless skin patch (previously called Raisin Personal Monitor) with which the sensor communicates. The sensor can be integrated into ingested products such as pharmaceuticals, to track when one actually swallows one of these substances.

The sensor measures 1mm square and is made mostly of silicon. It does not contain a battery, but is powered for a short amount of time by contact of two conductive materials with stomach acid. It sends a signal to the skin patch at the moment it reaches the stomach allowing the patch to record the exact time medication is taken, as well as the unique identity of that medication.

Besides communicating with the ingestible sensor, the patch records heart rate, temperature, activity and rest patterns. The patch is battery-operated and lasts approximately seven days, after which it must be replaced.

The Proteus ingestible sensor can be integrated into an inert pill or other ingested products, such as pharmaceuticals. Once the ingestible sensor reaches the stomach, it is powered by contact with stomach fluid and communicates a unique signal that determines identity and timing of ingestion. This information is transferred through the user’s body tissue to a patch worn on the skin that detects the signal and marks the precise time an ingestible sensor has been taken. Additional physiologic and behavioral metrics collected by the patch include heart rate, body position and activity. The patch relays information to a mobile phone application. With the patient’s consent, the information is accessible by caregivers and clinicians, helping individuals to develop and sustain healthy habits, families to make better health choices, and clinicians to provide more effective, data-driven care.

Source : http://proteusdigitalhealth.com/proteus-digital-health-announces-fda-clearance-of-ingestible-sensor/

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