Deka R&D Corp.
http://www.dekaresearch.com
Questions?
Please contact Sales at: (212) 520-2765 or email [email protected]
Latest From Deka R&D Corp.
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A new "leapfrog" draft guidance from the US agency addresses implanted brain-computer interface prosthetic devices, and, specifically, the information sponsors should be prepared to submit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.
Baxter’s Amia Automated Home Dialysis System Receives FDA Clearance
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.
Company Information
- Industry
- Medical Devices
You must sign in to use this functionality
Authentication.SignIn.HeadSignInHeader
Email Company
All set! This article has been sent to my@email.address.
All fields are required. For multiple recipients, separate email addresses with a semicolon.
DCD.EmailPopout.Notice