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Paro Robots positions stuffed animal as therapeutic device

This article was originally published in The Gray Sheet

Executive Summary

Firm plans Dec. 1 launch of its Paro Therapeutic Robot following its Sept. 21 designation by FDA as a Class II medical device exempt from pre-market notification requirements. The device looks like a stuffed harp seal pup but is an "intelligent, interactive" robot covered in white synthetic fur intended for use in nursing homes, assisted living facilities, retirement communities, hospitals and schools "for the purpose of therapy," the company claims. Paro "allows the documented benefits of animal therapy to be administered to patients in environments ... where live animals present treatment or logistical difficulties," according to the firm's Web site. It uses sensors and an on-board computer to process voice recognition and imitate animal behavior, enabling it to "develop its own character," the firm says. It respond to users "as if it is alive, moving its head and legs, making sounds, and showing your preferred behavior," the firm notes. While the $6,000 device has been used in Japan and Europe since 2003, and was unveiled in the U.S. in 2008, Paro said it pursued FDA regulatory clearance to aid future reimbursement efforts

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