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A new "leapfrog" draft guidance from the US agency addresses implanted brain-computer interface prosthetic devices, and, specifically, the information sponsors should be prepared to submit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.
Both an arm prosthesis and a device used in transcatheter valve replacement will be regulated via class II, FDA announced this week.
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.
Baxter received FDA 510(k) clearance in October for Amia, a home-based automated peritoneal dialysis system that features voice guidance, touchscreen control and two-way connectivity. With more than 600,000 people in the US living with end-stage renal disease, and 40,000 of these on peritoneal dialysis, the company is working to enhance renal care with patient-centric technologies that provide more individualized and efficient home-based therapy.
- Medical Devices