Search Tag: FDA

ICU Management

Masimo Announces FDA 510(k) Clearance for Radius-7® with rainbow® Technology

2016 28 Jun

Radius-7 is the First Wearable, Tetherless, Noninvasive rainbow® Monitor Masimo (NASDAQ: MASI) has announced FDA 510(k) clearance for Radius-7® – the first and only wearable, tetherless, noninvasive rainbow® monitor. Radius-7, which connects to the Root® patient monitoring and connectivity platform, is now available in the U.S. with breakthrough Masimo... Read more

Executive Health Management

FDA Approves Use of the Procleix Zika Virus Assay from Hologic & Grifols

2016 21 Jun

--Blood banks will use the new test, co-developed by Hologic and Grifols, to screen donated blood in potential endemic areas of the US----Test will run on the Procleix Panther System, a fully automated NAT blood screening platform--Hologic, Inc. (NASDAQ: HOLX) and Grifols (MCE: GRF, MCE: GRF.P and NASDAQ: GRFS) – market-leading partners committed to... Read more

IMAGING Management

MRI-Guided Ultrasound to Treat Tremor Gets OK From FDA

2016 12 Jul

The U.S. Food and Drug Administration (FDA) has given the green light to a focused ultrasound device that uses magnetic resonance (MR) images taken during the procedure to treat essential tremor in patients who have not responded to medication. ExAblate Neuro, manufactured by InSightec in Dallas, Texas, delivers focused ultrasound to destroy brain tissue... Read more

Cardiology Management

FDA Approves First Absorbable Cardiac Stent

2016 05 Jul

The US Food and Drug Administration (FDA) has approved the Absorb GT1 Bioresorbable Vascular System (Abbott Vascular), with the first absorbable stent for coronary artery disease.Nine members of the Circulatory System Devices panel vs 1 voted that it was safe, and 9 to 1 voted that it had an acceptable risk/benefit profile. In addition, all 10 members... Read more

IT Management

3D-printed Drug: Breakthrough in Precision Medicine

2015 10 Aug

The U.S. Food and Drug Administration has approved the first 3D-printed drug, SPRITAM®, for oral use as a prescription adjunctive therapy in the treatment of partial onset seizures, myoclonic seizures and primary generalised tonic-clonic seizures in adults and children with epilepsy.  The FDA approval is being hailed as a breakthrough in precision medicine.... Read more

Executive Health Management

10% of Adverse Drug Events Reported Miss Deadline

2015 28 Jul

According to an article published in JAMA Internal Medicine, approximately 10 percent of serious and unexpected adverse events are not reported by drug manufacturers to the U.S. FDA under the 15-day time frame that is set out in federal regulations. Drug manufacturers are required by law to report serious adverse events including death, life-threatening,... Read more

ICU Management

Rapid Ebola Diagnostic Successful in Field Trial

2015 29 Jun

Potential game changer for treatment and containmentA new test can accurately diagnose Ebola virus disease within minutes, providing clinicians with crucial information for treating patients and containing outbreaks.Researchers from Harvard Medical School, Partners In Health and Boston Children's Hospital have shown that a new commercially developed... Read more

ICU Management

Teleflex Incorporated Announces Worldwide Voluntary Recall of Hudson RCI® LIFESAVER®

2015 29 Jun

Teleflex Incorporated announced today that the U.S. Food and Drug Administration (FDA) has classified the voluntary medical device recall of Hudson RCI® LIFESAVER® Neonate Manual Resuscitator as a Class 1 recall. FDA defines Class I recalls as, “a situation in which there is a reasonable probability that the use of or exposure to a violative product... Read more

IMAGING Management

EOS imaging Reports 2014 Financial Results and Q1 2015 Revenue

2015 23 Apr

Strong growth in 2014 revenues: up 32%Continued improvement in gross margin: up 400 basis pointsQ1 2015 revenues increase 53% driven by USAEOS imaging (Paris:EOSI) (Euronext, FR0011191766 – EOSI), the pioneer in 2D/3D orthopaedic medical imaging, announced its consolidated annual results for the year ended December 31, 2014, as approved by the Company’s... Read more

Pharmacy Management

EMA Recommends Suspension of 700 Generic Medicines

2015 30 Jan

A committee of the European Medicines Agency (EMA) has made recommendations that the sale of four dozen generic drugs should be suspended. These include generic medicines for diabetes, depression and hypertension. The recommendations have been made on the grounds that the approval of these drugs was based on flawed clinical studies that had been conducted... Read more

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