Medical Equipment, Supplies & Distribution

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Visiomed Group receives FDA approval for Thermoflash products

Tuesday, 23 Dec 2014 12:30pm EST

Visiomed Group SA:Announces that all Thermoflash products received FDA approval in addition to the CE mark and registration with the ANSM.

Cerus Corporation announces FDA approval INTERCEPT Blood system for platelets

Thursday, 18 Dec 2014 07:20pm EST

Cerus Corporation:Says that the U.S. Food and Drug Administration (FDA) has approved the INTERCEPT Blood System for platelets.Says the INTERCEPT platelet system is approved for ex vivo preparation of pathogen-reduced apheresis platelet components in order to reduce the risk of transfusion-transmitted infection (TTI), including sepsis, and to potentially reduce the risk of transfusion-associated graft versus host disease.

FDA approves Cerus Corp's INTERCEPT blood system for Plasma

Tuesday, 16 Dec 2014 06:40pm EST

Cerus Corporation:Says that the U.S. Food and Drug Administration has approved the INTERCEPT Blood System for plasma.Says the INTERCEPT plasma system is approved for ex vivo preparation of plasma in order to reduce the risk of transfusion-transmitted infection (TTI) when treating patients requiring therapeutic plasma transfusion.

DiaSorin SpA says FDA approves 1,25 Vitamin D-Reuters

Tuesday, 16 Dec 2014 04:33am EST

DiaSorin SpA:Says it has received FDA clearance on commercialization of 1,25 Dihydroxyvitamin D on its Liaison XL in US market-Reuters.Says the fully automated test for the quantitative determination of Vitamin D levels in human serum samples is already available in Europe since June.

BioFirst receives patent in China

Monday, 15 Dec 2014 01:55am EST

BioFirst Corp:Received patent for double emulsion core-shell nano structure and preparation methods thereof in China.

Immunodiagnostic Systems Holdings plc receives European CE Mark declaration for IDS-iSYS 1,25 VitDXp assay

Friday, 12 Dec 2014 02:00am EST

Immunodiagnostic Systems Holdings plc:Receives European CE Mark declaration for the IDS-iSYS 1,25 VitDXp assay - assay for use with the IDS-iSYS Multi-Discipline Automated System.

BioFirst Corp gets patent for artificial vitreous technology

Wednesday, 10 Dec 2014 07:55pm EST

BioFirst Corp:Got patent for artificial vitreous technology named CROSS-LINKED OXIDATED HYALURONIC ACID FOR USE AS A VITREOUS SUBSTITUTE in Europe.

Great Basin Scientific Inc initiates clinical trial for Staph ID/R Molecular diagnostic test

Wednesday, 10 Dec 2014 05:00pm EST

Great Basin Scientific Inc:Initiates a clinical trial for its sample-to-result Staph ID/R (identification/resistance) diagnostic test.This is the second clinical trial the Company has initiated since July 2014 and, upon submission and if granted 510(k) clearance by the U.S. Food and Drug Administration (FDA), Staph ID/R will be Great Basin's third molecular diagnostic assay.In Nov. of this year, the Company submitted its Group B Strep assay to FDA for 510(k) clearance.In 2012 the Company launched its FDA-cleared Toxigenic C. diff assay.Further, company announced that it has added two additional tests, a fungal panel and a test for Shiga toxin-producing E. coli (STEC) infections, to its clinical trial roadmap for 2015.

FDA Grants Cytori Therapeutics Inc conditional approval for U.S. pivotal clinical trial in Scleroderma

Wednesday, 10 Dec 2014 08:00am EST

Cytori Therapeutics Inc:Says U.S. Food and Drug Administration (FDA) has granted conditional approval for Investigational Device Exemption (IDE) for pivotal clinical trial, named the 'STAR' trial.To evaluate Cytori Cell Therapy as potential treatment for impaired hand function in scleroderma, rare autoimmune disease affecting about 50,000 patients in United States.STAR trial is conditionally approved to be a randomized, double blind, placebo-controlled pivotal clinical trial of 80 patients in up to 12 U.S. sites.Trial evaluates the safety and efficacy of single administration of Cytori Cell Therapy in scleroderma patients affecting hands and fingers.More than 90 pct of scleroderma patients have hand involvement that is typically progressive and can result in chronic pain, blood flow changes and severe dysfunction.Limited available treatments for scleroderma may provide some benefit but do little to modify disease progression or substantially improve symptoms.

Vexim SA obtains FDA approval to market masterflowTM injection system in the United States

Wednesday, 10 Dec 2014 02:00am EST

Vexim SA:Says U.S. Food and Drug Administration (FDA) has approved the marketing in the United States of the company's MasterflowTM Injection System for mixing and injecting orthopedic cement.

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