Search Tag: FDA
FDA Guidance for Mobile Devices
2017 02 Jan
Amid criticism that it was not doing enough to address the cyber vulnerabilities in medical devices, the U.S. Food and Drug Administration has issued guidelines on how manufacturers can protect their products against cyberattacks. According to the guidelines, manufacturers must build cybersecurity controls into medical devices during the development... Read more
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... Read more
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... Read more
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... Read more
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... Read more
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... Read more
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
Rapid Ebola Diagnostic Successful in Field Trial
2015 29 Jun
Potential game changer for treatment and containment A 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
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