NeuRxDPS is approved in the United States under a Humanitarian Device Exemption
(HDE) for spinalcord injury (SCI) patients 18 years or older who have stimulatable diaphragms but lack control of their diaphragms.
Medtronic helped pioneer DBS, and more than 140,000 patients worldwide have received Medtronic DBS Therapy, which is approved in many locations around the world, including Europe and the United States, for the treatment of the disabling symptoms of essential tremor, Parkinson's disease and dystonia, the latter for which approval in the United States is under a Humanitarian Device Exemption
InVivo was expecting to file for a humanitarian device exemption
(HDE) on data from the pilot trial, enabling it to commercialize the scaffold in the United States by around mid-2015.
Under the special Humanitarian Device Exemption
approval, Medtronic can market its device, Reclaim DBS Therapy, for obsessive-compulsive disorder (OCD).
Danvers, MA, announced it has received US Food and Drug Administration (FDA) Humanitarian Device Exemption
(HDE) supplemental approval on systems upgrades for AbioCor, its implantable replacement heart.
The AbioCor was approved under a humanitarian device exemption
Prior to the approval, the US FDA reviewed data for the Flourish device through the humanitarian device exemption
The first transcatheter heart valve available anywhere in the world, the Melody TPV was originally approved in 2010 under a Humanitarian Device Exemption
(HDE), a regulatory approval for treatments intended for fewer than 4,000 U.
In 2011, BSD Medical obtained humanitarian device exemption
marketing approval for the BSD-2000 from the U.
At present, OP-1 products only are approved under a humanitarian device exemption
(HDE) for limited use in trauma situations and spinal surgery.
In addition to reviewing the use of artificial hearts as bridge to transplantation as requested by SynCardia, CMS will review other indications for which artificial hearts are currently on the market, through a humanitarian device exemption