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Latest From Petroci Gaz
FDA Revokes EUA For Curative Test, Slew Of Other COVID-19 Products
In an ongoing trend, the US agency announced it revoked a number of emergency use authorizations at the behest of manufacturers.
Thought-Controlled Prosthetics Get US FDA 'Leapfrog' Treatment
A new "leapfrog" draft guidance from the US agency addresses implanted brain-computer interface prosthetic devices, and, specifically, the information sponsors should be prepared to submit for pre-submissions meetings and investigational device exemptions.
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.
Robotic Arm Inventor Says 18 Months ‘Too Long’ To Approve Novel Device
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.
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