The platform, SmartFuse, is designed to remotely stimulate, control and monitor bone growth. The system’s remote monitoring allows real-time clinical decision making.
FDA breakthrough designation speeds up the development, assessment and review for select devices.
“We look forward to working closely with the FDA through future clinical trials and review processes for SmartFuse,” CEO John Zellmer said in a May 28 news release. “We expect to benefit from additional FDA input during premarket development as well during the submission process and through an expedited review once the submission is filed.”
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