Morton Plant Hospital has been participating in the FDA trial for intermediate risk patients since 2012.. Now, with the latest FDA approval, we will be able to offer TAVR to any intermediate risk patients with severe symptomatic aortic stenosis, "said Joshua Rovin, MD, FACS, cardiovascular surgeon and medical director, for the Center for Advanced V
In reaction to injurious rumours on the LaCasera brand, the LaCasera Company on Thursday opened its factory doors to stakeholders and journalists, who took a tour of its production plant in Lagos. The tour exposed stakeholders, including representatives of the National Agency for Food and Drug Administration and Control Director General, Manufactur
-Oculus Innovative Sciences, Inc., a specialty pharmaceutical company that develops and markets solutions for the treatment of dermatological conditions and advanced tissue care, today announced it has received a new 510 clearance from the U.S. Food and Drug Administration for the companys new post-dermal-procedures product. About IntraDerm...
Bio2 Medical is pleased to announce the Angel Catheter has received 510 clearance from the United States Food& Drug Administration. The Angel Catheter is now commercially available in the U.S. The entire team at Bio2 Medical is proud to provide physicians in the U.S. with a unique device that has the possibility of truly improving patient c
Qubyx PerfectLum, the software for calibration and consistent performance of medical workstations, bundled with the premium 8 MP monitor Dell UP3216Q, has received the FDA 510(k) market clearance for displaying and viewing of medical images, as well as for review and analysis by trained medical practitioners.
The first and only FDA- approved concussion-specific tool designed for individuals ages 5-11, ImPACT Pediatric provides health care professionals with objective measures of neurocognitive functioning for evaluation and management of concussion in younger children. Created by ImPACT Applications, the developer of the FDA- approved ImPACT ...
Oculus Innovative Sciences, Inc., a specialty pharmaceutical company that develops and markets solutions for the treatment of dermatological conditions and advanced tissue care, today announced it has received a new 510 clearance from the U.S. Food and Drug Administration for the company s new post-dermal-procedures product. Michael Gold,...
Release date- 23082016- DUBLIN- Perrigo Company plc today announced it has received tentative approval from the U.S. Food and Drug Administration for the generic version of Suprep oral solution. Perrigo today also announced that it was sued by Galderma Laboratories, L.P. and Nestle Skin Health S.A. over the Company's Paragraph IV ANDA filing for th
Perrigo Company plc today announced it has received tentative approval from the U.S. Food and Drug Administration for the generic version of Suprep oral solution. Perrigo's CEO John T. Hendrickson stated, "These accomplishments demonstrate Perrigo's commitment to our customers and consumers around the world. About Perrigo Perrigo Company plc,
By a News Reporter-Staff News Editor at Pharma Business Week Boston Scientific has received U.S. Food and Drug Administration approval for the EMBLEM? MRI Subcutaneous Implantable Defibrillator System, as well as magnetic resonance conditional labeling for all previously implanted EMBLEM S-ICD Systems. "Now with FDA approval, patients receivin
By a News Reporter-Staff News Editor at Pharma Business Week Centric Medical, a division of Life Spine, Inc., which focuses on developing surgical implants for the treatment of distal extremity pathology, announced that the U.S. Food and Drug Administration has given 510 marketing clearance to the Hammertoe Correction System. The Hammertoe Correc
Release date- 19082016- Pfizer Inc. announced today that the U.S. Food and Drug Administration has approved TROXYCA ER extended-release capsules, for oral use, CII for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. TROXYCA ER has propert
Traumatic brain injuries account for more than 2 million trips to the emergency room in the United States each year, the FDA said. The tests' Pittsburgh manufacturer, ImPACT Applications, submitted more than 250 peer-reviewed articles in support of their approval, the FDA said. Visit the FDA to learn more about this approval.
San Diego, CA 08/22/2016 Innovus Pharmaceuticals, Inc., an emerging commercial stage cash flow positive pharmaceutical company that delivers safe, innovative and effective over-the-counter medicine and consumer care products to improve men and women's health and respiratory diseases, today announced today that its partner Khandelwal Laborator
By a News Reporter-Staff News Editor at Pharma Business Week Magellan Diagnostics, a business unit of Meridian Bioscience, has received clearance from the China Food and Drug Administration for its LeadCare II Blood Lead Testing System. We are pleased to have obtained approval to market LeadCare II in China, where we hope it can help broaden the
NEW YORK CITY- Alere Inc. has received 510 marketing clearance from the FDA for its Alere i RSV test for the detection of RSV infection in children and adults. The Alere i molecular platform was initially cleared for marketing by the FDA for the detection and differentiation of influenza A and B virus in June 2014, and for Strep A in March 2015.
By a News Reporter-Staff News Editor at Medical Letter on the CDC& FDA BTL Aesthetics announced that it has received a new designation from the Food& Drug Administration for its award-winning, non-invasive fat reduction treatment, BTL Vanquish ME. The physician-favored treatment is now FDA- cleared for the circumferential reduction of the abdomen
Ipsen Biopharmaceuticals, Inc. announces FDA approval of Dysport abobotulinumtoxinA for the treatment of lower limb spasticity in pediatric patients aged two and older. By a News Reporter-Staff News Editor at Medical Letter on the CDC& FDA Ipsen Biopharmaceuticals, Inc., a subsidiary of Ipsen SA, announced that the U.S. Food and Drug Administr