August 2, 2012
FDA Approves Tiny Computer Chip As Internal MD
John Neumann for redOrbit.com - Your Universe Online
Following four years of discussions, the US Food and Drug Administration (FDA) has approved a computer that can monitor the health of a patient from within their body. The Ingestion Event Marker from Proteus Digital has received approval for the very tiny (less than 1/10th inch) computer chip it plans on using as an internal MD.Once a sensor on the chip, which is swallowed, comes into contact with stomach acids it acts as an electrolyte, generating 1-2 volts of power between the copper salt cathode and a magnesium anode, reports Iain Thomson for The Register.
“We are thrilled to have achieved this important milestone to market our ingestible sensor in the United States now, as well as in Europe,” Dr. George M. Savage, co-founder and chief medical officer at Proteus Digital Health, said in a press release.
The few volts that are generated provide just enough power to relay a signal that documents exactly when the pill was swallowed. Data is then transmitted to a battery-powered patch worn on the skin which has a life span of seven days, collecting several metrics, including heart rate, temperature, and body position, which is also relayed to a mobile-phone app.
If the patient consents, this data is shared with caregivers and clinicians to help develop patient-specific and data-driven care.
“The point is not for doctors to castigate people, but to understand how people are responding to their treatments,” Savage said to Nature. “This way doctors can prescribe a different dose or a different medicine if they learn that it´s not being taken appropriately.”
Some doctors feel that the device will be able to help with medicine adherence, in other words getting people to continue taking their medication, reports Michelle Castillo for CBS News.
Although not quite the same scenario as the classic film Fantastic Voyage, where a team of doctors were shrunk to nano-size and journeyed through a patient, the Ingestion Event Marker is very basic at this early stage but technology is certainly being worked on that allows medical robots small enough to maneuver through the body and perform repairs.
Dr. Eric Topol, a professor of genomics at The Scripps Research Institute says in a news release that the digital health feedback system is an emerging technology that could improve not only a patient´s adherence to a treatment regimen but also chronic-disease management: “The FDA validation represents a major milestone in digital medicine.”
Proteus Digital cannot confirm a cost for such chips yet, stating that it depends on “the context in which the system is being used.” Time will tell if insurance providers will cover the system now that it has been cleared by the FDA, writes CNET Elizabeth Armstrong Moore.
This FDA approval is an important step in allowing the use of implantable computers, to improve human health. The EU has already approved the Proteus Digital designs and certified them as safe for human use. With the FDA decision, the company now has access to the most expensive healthcare market in the world.