FDA News: Medspira Receives FDA Clearance

Medspira Receives FDA 510K Clearance for mcompass Anorectal Manometry Device.

Full press release below.

SOURCE: Medspira

Makes Testing Practical for a Wide Range of Medical Specialists

MINNEAPOLIS--(BUSINESS WIRE)--Medspira has received U.S. Food and Drug (FDA) 510K clearance for its innovative mcompass anorectal manometry device. Anorectal manometry testing evaluates pelvic floor function in patients with constipation or fecal incontinence.

“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.”

Incorporating a range of unique features, mcompass is designed to make testing highly accurate, easy to perform and practical for a broad range of medical specialists. In addition to colorectal surgeons and gastroenterologists, Medspira will market the device to 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,” says Jim Quackenbush, CEO of Medspira. “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.”

Unlike today’s more complex and cumbersome anorectal devices, mcompass is portable, compact and weighs only three pounds. Other systems usually require a cart and dedicated room, while mcompass can be set up anywhere in minutes. Testing can be easily conducted in nursing homes or other community locations.

Intuitive and user-friendly, mcompass comprises three simple components—a disposable catheter, mobile tablet PC and wireless portable manometer. Built-in software prompts guide even inexperienced users through the testing process. The device is ready for use within seconds due to an innovative priming method, and results display in real time on the device’s tablet PC workstation. The full encrypted data packet can be emailed to specialists for interpretation, if needed, in a few clicks using the device’s built-in Wi-Fi connectivity.

In addition, mcompass features an innovative, disposable catheter for enhanced testing accuracy and a proprietary single-connector to streamline set-up. The catheter comprises a central rectal balloon and four radial anal canal balloons at 90 degree relative positioning. Each balloon provides independent measurement. The device’s anal canal balloon is 20 mm long, enabling one or two positioned full anal canal measurements. A non-compliant rectal balloon supports true rectal compliance testing. (Continued: http://www.healthflashmarketing.com/Medspira%20mcompass%20510k%205-21-12.pdf)

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