Medspira has announced it has received FDA 510(k) clearance for its mcompass anorectal manometry device, according to a news release.
The device, which evaluates pelvic floor function in patients with constipation or fecal incontinence, will be marketed to colorectal surgeons, gastroenterologists, primary care physicians, gerontologists, URO/GYNs and OBGYNs.
"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 the 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 is headquartered in Minneapolis.
Related Articles on FDA Clearances:
Boston Scientific Receives FDA Approval for Epic Vascular Stent
Covalon Receives FDA Approval for Antimicrobial Silicone Adhesive Film
MAQUET Cardiovascular Receives FDA 510(k) Clearance for New Intra-Aortic Balloon Catheter Sizes