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Latest FDA Stories

2014-06-30 08:29:38

FluidSmart(TM) System Now FDA Cleared for Surgical Irrigation and Warming in Orthopedics, Gynecology & Urology CLEVELAND, June 30, 2014 /PRNewswire-USNewswire/ -- Thermedx, LLC, an innovative designer and manufacturer of "smart" surgical irrigation products, received FDA 510(k) clearance for optional fluid warming in arthroscopic and hysteroscopic procedures. Building upon its prior FDA 510(k) clearance(s) for irrigation, distension, and deficit monitoring in gynecology, urology,...

2014-06-30 08:29:23

Offers State-of-the-Art Technology - The Future of Hair Restoration IRVINE, Calif., June 30, 2014 /PRNewswire/ -- Hair loss specialist Ken L. Williams Jr., D.O., proudly announces the availability of the FDA-cleared ARTAS Robotic System at his private practice, the OC Hair Restoration Center, in Irvine, California. Widely respected as a leader in the field of hair restoration, Dr. Williams has practiced medicine in Orange County since 1986. From the heart of Silicon Valley - the...

Afrezza Inhalation Powder
2014-06-29 04:56:44

April Flowers for redOrbit.com - Your Universe Online Treatment options for diabetes come in a wide variety, ranging from oral medications to insulin pumps. USA Today reports that a new treatment option has been added to the arsenal, Afrezza Inhalation Powder. This week, the US Food and Drug Administration (FDA) approved the rapid-acting inhaled insulin to improve glycemic control in adults with diabetes mellitus, or Type I diabetes. The FDA estimates that 25.8 million people in...

Exoskeleton System ReWalk Approved For Sale In The US
2014-06-29 04:41:34

Alan McStravick for redOrbit.com - Your Universe Online This year's FIFA World Cup, being played in Brazil, is a quadrennial event that captures the attentions of a staggering majority of the people that live on this planet. Excusing the pun, the event kicked off by celebrating a revolutionary advancement in paraplegic mobility technology made possible by work done by one of Brazil's native sons, Dr. Miguel A. L. Nicolelis, MD, PhD. Heading up the Walk Again Project, Nicolelis explained...

2014-06-27 23:10:35

In May 2014, the FDA released a draft guidance that covers the selection and approval process for proposed names of both prescription and nonprescription human drugs and biologics. FDAnews has teamed with drug-naming expert Dr. Susan Proulx to present a 90-minute webinar that will look closely at the draft guidance and its recommended 4-step process. Falls Church, VA (PRWEB) June 27, 2014 Choosing the Right Drug Name: How to Increase Your Chances for Approval **FDAnews Webinar** July...

2014-06-27 23:08:09

On June 23, the FDA issued a safety communication on mammography problems at Big Sky Diagnostic Imaging, LLC in Butte, Montana. In light of this news, AttorneyOne, a recognized authority on law, updated the website providing detailed information to consumers. San Diego, CA (PRWEB) June 27, 2014 AttorneyOne.com, a recognized authority on law, update the website daily regarding all the latest information from the FDA on safety alerts for mammograms. The FDA issued a safety communication on...

2014-06-27 08:25:02

Revolutionary technology that allows individuals with Spinal Cord Injury, such as paraplegia, to stand & walk receives clearance for personal use in the U.S. MARLBOROUGH, Mass., June 27, 2014 /PRNewswire/ -- Exoskeleton leader ReWalk Robotics announced today that the U.S. Food and Drug Administration has cleared the company's ReWalk Personal System for use at home and in the community. ReWalk is a wearable robotic exoskeleton that provides powered hip and knee motion to enable...

2014-06-27 08:23:26

NEW YORK, June 27, 2014 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA), based in Silver Spring, Maryland provides a variety of public health services in the United States through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter (OTC) pharmaceutical drugs, vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics and veterinary...

2014-06-26 23:16:39

With 15 interactive exercises this workshop, taught by internationally renowned medical device process validation expert Dan O’Leary, is designed to provide industry best practices to achieve sustainable process validation with regulatory bodies around the world. Attendees will learn the theories of process validation and documentation and how to put them into practice. Falls Church, VA (PRWEB) June 26, 2014 Innovative Process Validation Strategies for Medical Devices: Proving Your...

2014-06-26 23:16:13

On June 20, the FDA announced that all Flexi-Seal CONTROL Fecal Management System Kits are recalled (Class I) by ConvaTec, Inc. as no 510k application was submitted to FDA. In light of this news, AttorneyOne, a recognized authority on law, updated the website providing detailed information to consumers. San Diego, CA (PRWEB) June 26, 2014 AttorneyOne.com, a recognized authority on law, update the website daily regarding all the latest information from the FDA on Flexi-Seal CONTROL Fecal...


Word of the Day
attercop
  • A spider.
  • Figuratively, a peevish, testy, ill-natured person.
'Attercop' comes from the Old English 'atorcoppe,' where 'atter' means 'poison, venom' and‎ 'cop' means 'spider.' 'Coppa' is a derivative of 'cop,' top, summit, round head, or 'copp,' cup, vessel, which refers to 'the supposed venomous properties of spiders,' says the OED. 'Copp' is still found in the word 'cobweb.'
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