Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


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A new "leapfrog" draft guidance from the US agency addresses implanted brain-computer interface prosthetic devices, and, specifically, the information sponsors should be prepared to submit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.

Innovation Regulation

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.

Regulation Medical Device

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.

Regulation Innovation

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.

Medical Device Innovation
See All

Company Information

  • Industry
  • Medical Devices