GlaxoSmithKline has received approval from the UK’s National Institute for Health and Clinical Excellence (NICE), for its platelet-boosting drug Revolade in the treatment of adult bleeding disorder, chronic immune (idiopathic) ...
Tags: Blood Disorder Treatment, Medicine
Cerus' proposed modular premarket approval (PMA) application shell for Intercept Blood System for platelets has been accepted for review by the US Food and Drug Administration (FDA). The PMA application shell accepted by the FDA for the ...
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Terumo BCT's automated blood collection system, designed for collecting and storing platelets in Isoplate platelet additive solution (PAS). The solution, which ...
Regenerative therapies company Cytomedix has received clearance from the Therapeutic Goods Administration (TGA) to commercialize its Angel cPRP system in Australia. The approval allows the company to use the system in the clinic or ...
Tags: Cytomedix, TGA, Angel cPRP system
Accumetrics' VerifyNow II System has received CE marking for point-of-care measurement of platelet reactivity to antiplatelet agents. The receival of Ce mark is expected to expand the market opportunities for the VerifyNow System in both ...
Tags: Accumetrics, VerifyNow II System, CE marking, platelet reactivity
The US Food and Drug Administration (FDA) has granted 510(k) clearance to AngioDynamics' BioFlo peripherally inserted central catheters (PICCs) with a permanent and non-eluting integral polymer Endexo technology. The BioFlo PICCs is ...
Tags: FDA, clearance, PICCs, BioFlo PICCs, PASV Valve technology
Global healthcare firm Abbott's everolimus eluting coronary stent system has been accorded with CE Mark in Europe. The XIENCE Xpedition everolimus eluting coronary stent system, which is used to treat coronary artery disease, provides ...
Tags: Abbott, CE mark, coronary stent system, coronary artery disease
Cytomedix has featured its AutoloGel system at the Native American Wound Care Conference and Diabetic Limb Salvage Conference. The FDA-cleared AutoloGel system is designed for the production of autologous platelet rich plasma (PRP) for ...
Tags: Cytomedix, AutoloGel system, PRP, wound management
The US Food and Drug Administration (FDA) has granted 510(K) approval to Cytomedix to use its Angel Concentrated Platelet Rich Plasma (cPRP) system to process a small sample of blood or a mixture of blood and bone marrow aspirate. ...
The US Food and Drug Administration (FDA) has approved Immunetics' BacTx rapid test to detect bacterial contamination in platelet units. The clearance allows BacTx test to use on leukocyte-reduced whole blood-derived platelet units, a ...
T2 Biosystems has announced data of its T2Hemostasis monitoring system at the 54th Annual Meeting of the American Society for Hematology (ASH) which is being held in Atlanta, Georgia, US. The system has the capability to characterize key ...
Tags: T2 Biosystems, monitoring system, key coagulation, platelet, health
Eckart GmbH has been granted a patent for platelet-shaped, copper-containing, metallic effect pigments, which have a copper content of 60% to 100% by weight, based on the total metal content, wherein the metallic effect pigments have a ...
The U.S. Food and Drug Administration (FDA) has cleared Immunetics Incorporation's BacTx rapid test used to detect bacterial contamination in platelet units. The clearance allows BacTx test use on leukocyte-reduced whole blood-derived ...
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Semprus BioSciences' vascular access catheter, designed to provide peripheral access to the central venous system. Using Semprus Sustain technology, the ...
RS Medical is set to distribute Harvest Technologies' Terumo SmartPReP 2 platelet concentrate system, as part of a recently completed agreement. Harvest, a Terumo Americas Holding company, is involved in developing point-of-care ...
Tags: clinical technology, cellular platform, company cooperation