PRESS RELEASE

2014.11.15 update

【News】CYBERDYNE Inc. submitted final application for market clearance from the U.S. Food and Drug Administration (“FDA”) ~ the first DeNovo submission by a Japanese company for a “novel” medical device

CYBERDYNE Inc. (“the Company”) submitted a final application for market clearance from FDA to market Robot Suit HAL for Medical Use as a medical device in the United States, on November 14, 2014 U.S. time. This is the first DeNovo (*1) submission as a Japanese company for a “novel” medical device.

After the accepting the application, FDA will determine its classification and conduct a review before giving clearance as a medical device. As FDA guideline stipulates that examination period for De Novo submission is 120 days, we aim to get clearance by the end of next year, 2015, considering the time necessary for interaction with the FDA during the review process.

 (*1) De Novo submission: This is a special application route for novel medical equipment, whose risk level to life and patient is considered to be low~moderate. When cleared, a new classification for the device is newly established. The feature of this process is that it does not require a clinical trial procedure, which is mandatory in PMA process for medical devices with high risk. “De Novo” is a Latin expression meaning “anew”.

 

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