Friday, April 23, 2021

Tag: FDA

ReNetX Bio Receives Fast Track Designation From U.S. FDA

Potential First-in-Class Therapy for Chronic Spinal Cord Injury NEW HAVEN, Conn., Jan. 08, 2020 (GLOBE NEWSWIRE) -- ReNetX Bio announced today that the U.S. Food and Drug Administration (FDA) has granted the company Fast Track Designation for...

StemCyte Receives Phase II Investigational New Drug (IND) Clearance from the U.S. Food and...

BALDWIN PARK, Calif., Jan. 3, 2019 /PRNewswire/ -- StemCyte is pleased to announce that the U.S. Food and Drug Administration (FDA), on December 14, 2018, approved its Phase II Investigational New Drug (IND) application for...

A Reboot For Wheelchair That Can Stand Up And Climb Stairs

Thirteen years ago, just as the United States began what was to become its longest war, a futuristic wheelchair hit the market. The iBOT allowed paralyzed people, including many veterans of Iraq and Afghanistan, to...

User-Friendly Urinary Catheter Designed by Quadriplegic Gets FDA Clearance

Adapta Medical, Inc. to Expand Catheter Product Line COLORADO SPRINGS, Colo., Oct. 6, 2016 /PRNewswire/ -- Adapta Medical, Inc. has received FDA market release for the PerfIC Cath® intermittent touchless urinary catheter. The sterile catheter...

InCube Labs Announces $10 Million Department of Defense (DoD) Subcontract

Company will Collaborate with The University of Pittsburgh to Develop an Implantable Device for Spinal Cord Injury Patients SAN ANTONIO, May 24, 2016 /PRNewswire/ -- InCube Labs, a multi-disciplinary life sciences R&D lab, today...

Ekso GT™ Robotic Exoskeleton Cleared by FDA for Use With Stroke and Spinal Cord...

First robotic exoskeleton cleared for use with stroke and spinal cord injury levels to C7 RICHMOND, Calif., April 04, 2016 (GLOBE NEWSWIRE) -- Ekso Bionics Holdings, Inc. (OTCQB:EKSO), a robotic exoskeleton company, today announced that...

FDA Clears Parker’s Indego® Exoskeleton for Clinical, Personal Use

State-of-the-Art Device Allows Individuals with Spinal Cord Injury to Stand and Walk; Regulatory Clearances in USA and Europe Pave the Way for Commercialization CLEVELAND, March 10, 2016 (GLOBE NEWSWIRE) -- Parker Hannifin Corporation (NYSE: PH),...

Acorda Wins $2.67M Army Contract for Spinal Cord Injury Drug Trial

Acorda Therapeutics said today it won a $2.67 million contract from the U.S. Army Medical Research and Material Command (USAMRMC) to support development of AC105 as a treatment for acute spinal cord injury (SCI). The...

The Race To Cure Spinal Cord Injuries

A Big Opportunity - For Everyone Spinal Cord Injury (SCI) refers to an injury to the spinal cord that is caused by direct trauma or secondary damage to the surrounding bone, tissue, or blood vessels....

Neuralstem Receives FDA Approval To Commence Spinal Cord Injury Trial

NSI-566 to be tested in patients with chronic spinal cord injury ROCKVILLE, Md., Jan. 14, 2013 /PRNewswire/ -- Neuralstem, Inc. (NYSE MKT: CUR) announced that it received approval from the United States Food and Drug Administration...