Thoratec Corporation, a world leader in mechanical circulatory support therapies to save, support and restore failing hearts, announced that the FDA has granted conditional approval for a U.S. Final FDA approval is expected in the coming months pending resolution of certain routine technical questions. "Swift FDA approval of our newly proposed U
Ventripoint Diagnostics Ltd. is pleased to announce that it has received Marketing Clearance from the U.S. Food& Drug Administration for the expanded Indications for Use of its VMS? product which states; "The VMS system is indicated for use where RV volumes and ejection fractions are warranted or desired". "This change in use criteria means phys
MARLBOROUGH, Mass., May 26, 2015/ PRNewswire-USNewswire/ Verax Biomedical today announced that the company has gained FDA clearance to expand the use of its Verax Platelet PGD test a rapid test for the detection of bacterial contamination in platelets intended for transfusion. The new FDA clearance makes the Verax Platelet PGD test the only
VertiFlex , Inc., a leading innovator of advanced minimally invasive interventions for spinal stenosis, announced today that the U.S. Food and Drug Administration has issued a PMA Approval Order for the company s Superion Interspinous Spacer System, clearing the way for commercialization in the United States. Largest, most robust IDE device
TEHRAN- New research has led to FDA approval of the use of a drug to treat the effects of radiation exposure following a nuclear incident. The research was done by Thomas J. MacVittie, PhD, professor, and Ann M. Farese, MA, MS, assistant professor, both in the University of Maryland School of Medicine Department of Radiation Oncology's Division of
By a News Reporter-Staff News Editor at Pharma Business Week Nevro Corp., a medical device company that is providing innovative evidence-based solutions for the treatment of chronic pain, announced that it has received approval from the United States Food and Drug Administration for its Senza spinal cord stimulation system. Nevro also announced t
Ventripoint Diagnostics Ltd. is pleased to announce that it has received Marketing Clearance from the U.S. Food& Drug Administration for the expanded Indications for Use of its VMS? product which states; "The VMS system is indicated for use where RV volumes and ejection fractions are warranted or desired." "This change in use criteria means phys
By a News Reporter-Staff News Editor at Heart Disease Weekly "The launch of the Protege MRI system provides physicians with a solution that offers the benefits of future therapy upgrades as they are approved without the need for a future surgery," said Robert Levy, M.D., Ph.D., director of the Marcus Neuroscience Institute in Boca Raton, Florida.
Cellceutix Corporation, a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, and antimicrobial applications, is pleased to announce that the Institutional Review Board overseeing the Company's Phase 1 clinical trial of Kevetrin for the treatment of advanced solid tumors being conducted at Harvard...
LONDON- ReNeuron Group PLC Friday said the US Food and Drug Administration has given a Fast Track designation to the company's human retinal progentiro cell therapy candidate for the treatment of retinitis pigmentosa. The fast track status grant comes after ReNeuron earlier this month said it has received regulatory approval in the US for a phase 1
The announcement comes just one month after Aptensio XR received approval from the U.S. Food and Drug Administration. "While there are a number of treatment options available for patients with ADHD, there continues to be an unmet need as many patients struggle to achieve symptom control," said Robert Kupper, PhD, Vice President and Chief Technolog