(NaturalNews) The U.S. Food and Drug Administration (FDA) has approved a new method for inspecting the large intestine, also known as a colonoscopy, a procedure so unpleasant, and arguably painful, that many skip it, despite its high recommendation for those over 50 years old.
While the new, less invasive method is not a substitute but an alternative, it includes the patient swallowing a bite-sized camera that travels throughout the intestine, snapping internal photographs, which are then sent to a device worn around the patient's waist and later reviewed by a physician.
The device, known as PillCam, has been around since 2001 but was unable to compete directly with a regular colonoscopy because of the photographs' lack of clarity. The FDA's recent approval allows the device to be used as a substitute for those who cannot undergo a regular colonoscopy procedure, a demographic of nearly 750,000 U.S. patients annually.
PillCam was developed from missile defense systems by an Israel-based company called Given Imaging (GI) and is available in 80 countries including Japan and countries in Europe and Latin America In addition to its Israel-based headquarters, GI maintains several operating subsidiaries in the U.S., Germany, France, Japan, Australia, Brazil, Hong Kong and Vietnam.
Inconsistency in FDA approval process
Recent reports revealed that the FDA's method for approving medical devices and prescription drugs is anything but consistent; however, PillCam underwent testing that included 884 patients at 16 sites. Clinical trial results showed the "sensitivity for PillCam COLON was 88% and specificity was 82% in detecting adenomas at least 6 millimeters in size."
Although there are likely important benefits associated with this new imaging device, because of ulterior financial motives behind most FDA approvals, one has to wonder what side effects, if any, exist.
Douglas Rex, M.D., Distinguished Professor of Medicine and Chancellor's Professor at Indiana University School of Medicine, says the polyp-detecting device is a "minimally invasive, radiation-free option that provides endoscopic images of the same basic type that has made colonoscopy so useful."
GI claims that the PillCam has a "low to moderate risk that [has] no predicate on the market."
Colon imaging has a global market of 3 million procedures a year, creating opportunity for a tremendous profit. Analysts estimate PillCam sales to reach over $60 million in North America alone by 2019.
Debbie Wang, an analyst with MorningStar, said using the PillCam for colon imaging is extremely competitive financially in that it costs roughly $500 in comparison to a $4,000 colonoscopy.
The PillCam technology is similar to that of the "smart pill," or the "Helius system," a pill developed by California-based company Proteus Biomedical, Inc. The smart pill, a tiny digestible, silicon-based chip, has the capability of notifying your physician once a prescription drug has been ingested. Upon digestion, the pill's trace amounts of magnesium and copper mix with your stomach acid resulting in an electrical charge that's sent to an external skin patch. The patch transmits the data to your iPhone or computer, from where it is then sent directly to your doctor.
In addition to notifying your doctor that the pill has been taken, it's also capable of providing a full-body analysis, including heart rate, body temperature, exercise levels and sleep patterns, and can even inform you of your next scheduled dosage.
Reports confirm that the leading developer of technology imaging, GI, is to be purchased by medical device manufacturer Covidien PLC. The $860 million deal is to be completed by March 2014.