Warning Letter: Exoskeleton Firm Dodged Communication With FDA Over Postmarket Study, Failed To Assemble Surveillance Plan
This article was originally published in The Gray Sheet
An FDA warning letter sent to Argo Medical Technologies, now named ReWalk Robotics, outlines the company's failure to conduct mandatory postmarket surveillance activities on its ReWalk bionic walking assistance system. The missive to Argo also lays out a timeline of events that describes how the agency chased after the company.
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When it comes to helping patients recover from spinal cord injuries and stroke, the use of exoskeletons – a robotic suit that supports a person's weight and helps them move their limbs – is gaining traction by physical therapists in rehabilitation centers and clinical settings. Several exoskeleton companies such as ReWalk, Ekso Bionics and Parker Hannifin are already marketing their own versions of these smart, robotic-assisted body suits in various countries worldwide. Despite facing significant barriers, such as high device cost and lack of reimbursement, recent advances in robotics, microelectronics, battery technologies and product designs are the driving forces behind the continuous innovation in this field. Companies hope the dramatic life-changing impact exoskeletons have today in helping the paralyzed will also have implications for other mobility-challenged individuals, including those living with Parkinson's disease, multiple sclerosis, cerebral palsy and the elderly.
FDA Warning Letters For Olympus, Fujifilm, Pentax: Duodenoscope-Makers Fail To Meet Agency's Post-Market Surveillance Study Order
US FDA sent the letters toOlympus Corp., Fujifilm Medical Systems USA Inc. and Pentax Medical after the firms failed to meet obligations to conduct Sec. 522 post-market studies on their duodenoscopes, the use of which caused a number of antibiotic-resistant superbug infections in 2013 and 2014.
The agency has issued a final guidance on Sec. 522 postmarket study orders about five years after a draft version. In the interim, Congress stipulated a 15-month deadline for companies to start the FDA-mandated studies, a requirement emphasized in the new document.