A fecal incontinence test has won regulatory approval, announced the company that originally licensed the technology from the Mayo Clinic in 2009.
Medspira, based in Minneapolis, said the U.S. Food and Drug Administration has approved its mcompass anorectal manometry device that can evaluate how the pelvic floor of a person with constipation or fecal incontinence functions.
The system comprises three components: a disposable catheter, mobile tablet PC and wireless portable manometer. The test can be conducted by even inexperienced users, noted the company in a news release, and results are displayed on the tablet PC in real time. The fully secure data can be emailed to specialists for review and interpretation.
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Fecal incontinence plagues the elderly mainly and an estimated 18 million Americans experience it.
“Fecal incontinence and related chronic constipation are major medical problems and growing significantly with today’s aging population,” said Jim Quackenbush, CEO of Medspira, in a news release. “Yet, despite the health and lifestyle consequences, only one in 13 patients with fecal incontinence or chronic constipation is tested to determine the cause of their disorder. Often, sufferers are provided a range of treatments that fail to address the root of their problem.”
Medspira expects to market the product to colorectal surgeons and gastroenterologists, as well as to primary care physicians, gerontologists, URO/GYNs and OBGYNs.
Aside from mcompass, Medspira also makes the Breath Hold device, which enables patients to maintain consistent breathing during imaging exams and other medical procedures where breathing plays a role. In November, Medspira announced that Philips Healthcare would be offering its Breath Hold interactive tool along with its imaging system to help patients maintain consistent breathing during CT and other imaging tests.
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A third device is a small extremity coil made exclusively for GE MRI systems. It can be used to scan hands, fingers, wrists and other small parts of the body.
In September, the company announced that it had raised $2.25 million from a private investment firm.
[Photo Credit: freedigitalphotos user Surachai]
