FDA Formally Classifies Cardiac Surgery Device, Robotic Arm
Both an arm prosthesis and a device used in transcatheter valve replacement will be regulated via class II, FDA announced this week.
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US FDA needs to speed up its approval procedures for review of revolutionary devices like the LUKE prosthetic arm, says its inventor Dean Kamen. The arm was launched by Mobius Bionics on July 8. Kamen took a few moments after testifying at a House robotics hearing to explain its capabilities to Medtech Insight and share his thoughts about the FDA device review process and the spirit behind the 21st Century Cures bill.
A look at Medtech Insight's Approval Tracker data shows that last month was a relatively active one for US FDA approvals of novel devices via the PMA, panel-track supplement and de novo routes. But 510(k) clearance totals are down so far in 2016 compared to recent years.
The US agency is warning manufacturers about an alarming device submission trend toward unreliable data generated by third-party labs.