The ADA reminds dentists of the Food and Drug Administration’s MedWatch voluntary reporting form to report poor clinical outcomes associated with the use of medical devices, including direct-to-consumer plastic teeth aligners offered by several companies. This resource provides important data to the FDA concerning the public health and safety of medical devices under the agency’s jurisdiction. To … Read more
The US Food and Drug Administration (FDA) issued a notice requesting nominations for voting members to serve on the Medical Devices Advisory Committee (MDAC) device panels, which reviews data on the safety and effectiveness of marketed and investigational devices and makes recommendations for their regulation. The notice, published on Aug. 30, indicates that expertise is needed for … Read more
From Forbes In a New York Times Op-Ed piece on Monday, Eric Topol comments on last week’s announcement by the FDA that it was changing the label for statins. Topol focuses on the new warning that statins raise the risk of diabetes. He opens with a provocative statement: We’re overdosing on cholesterol-lowering statins, and the consequence could be a … Read more
From Reuters Health Information September 9, 2011 — ADELPHI, Md. (Reuters) – U.S. health advisers are considering a time limit for taking a class of drugs used by millions of women to prevent bone fractures, due to concerns over unusual fractures linked to the medicines and possible higher cancer rates. Two U.S. Food and Drug Administration … Read more
From Health News, by Susan Brady, May 9, 2011 Last Friday, the FDA cleared a diagnostic test that will be able to quickly determine staph infections and their resistance to antibiotics. Staphylococci bacteria are common in infections, but many are methicillin resistant (MRSA) or methicillin susceptible (MSSA) and required altered treatment protocols. Being able to … Read more
from PRWeb.com There is a raft of new and innovative materials in the constellation of bone augmentation…. curasan AG Receives License for Ceracell® Dental in the USA curasan AG has received FDA certification for its new granular bone regeneration material Ceracell® Dental Kleinostheim, Germany, May 07, 2011 –(PR.com)– curasan AG, listed in the General Standard … Read more
Written by Jeffrey Wolf IRVING, Texas – The FDA is listening to people worried about toxic teeth. Dentists say some fillings could be harmful to your health and fillings are big business. Seventy eight percent of Americans have at least one cavity by the time they are 17. Most people like the newer, white composite … Read more
Patient has advanced gum disease also known as Severe Periodontal disease. She would like a pretty smile. LANAP is an FDA cleared laser periodotal procedure that is FDA cleared to reverse gum disease. Invisalign is an alternative to braces. Veneer was placed to finish the case. http://lasergumdentist.com/ Related articles Treating Gum Disease (everydayhealth.com) Oral Hygiene, … Read more
St. Renatus, LLC, With Guidance From The U.S. Food And Drug Administration, Has Established Readiness To Proceed To Phase 3 Trials From Medical News Today St. Renatus, LLC, the northern Colorado start-up Company dedicated to bringing to market a needle-free dental anesthetic, announced that the company had a favorable End of Phase 2 review with … Read more
By Susan Heavey WASHINGTON (Reuters) – U.S. health regulators are seeking a second opinion on whether mercury-containing dental fillings pose a risk to dental patients, especially children and pregnant women. Food and Drug Administration officials said that while there are no new scientific findings on such silver-colored cavity fillings, it wants feedback on methods it … Read more