Regulatory Updates: Page 66

Sleep apnea implant device in clinical trials

By DrBicuspid.com staff writers

Inspire Medical Systems, a developer of neurostimulation therapies for the treatment of obstructive sleep apnea, recently received approval from the FDA to begin a clinical trial of its STAR (stimulation therapy for apnea reduction) implant system.

December 27, 2010

Md. dental group pays insurance fines

By DrBicuspid.com staff writers

Group Dental Service of Maryland was ordered to pay $5,000 to Maryland insurance regulators after it failed to comply with all the terms of a previous agreement, according to an article in Insurance and Financial Advisor.

December 19, 2010

Institute of Medicine studying safety of EHRs

By DrBicuspid.com staff writers

The Institute of Medicine's (IOM) Committee on Patient Safety and Health Information Technology met for the first time this week to begin discussing how best to regulate electronic health record (EHR) systems and ensure public safety, according to a story by the Center for Public Integrity.

December 16, 2010

FDA panel calls for more research of amalgam risks

By Mary Otto

Labeling for dental amalgam should more clearly inform dental practitioners and their patients of the potential risks posed by the mercury it contains, an expert panel advised the U.S. Food and Drug Administration (FDA) during the second day of a two-day public hearing this week.

December 15, 2010

FDA panel begins dental amalgam scrutiny

By Mary Otto

Amalgam opponents spent the first day of a two-day FDA meeting called to re-examine the safety of this restorative material questioning the existing research and demanding more government regulation. Will the agency's findings put an end to the debate, once and for all?

December 13, 2010

Irish dental council revises radiation guidance

By DrBicuspid.com staff writers

On December 10, the Dental Council of Ireland issued a new guidance document regarding the use of ionizing radiation in dentistry.

December 9, 2010

U.S. FDA to re-examine metal dental fillings

By Reuters Health

WASHINGTON (Reuters) - The U.S. Food and Drug Administration (FDA) is seeking a second opinion on whether mercury-containing dental fillings pose a risk to dental patients, especially children and pregnant women.

December 9, 2010

New Zealand seeks warnings on teeth whiteners

By DrBicuspid.com staff writers

The Environmental Risk Management Authority of New Zealand is seeking comments on proposed changes to the rules on the use of hydrogen peroxide as a teeth whitener.

December 8, 2010

Align Technology responds to FDA warning letter

By DrBicuspid.com staff writers

Align Technology received a warning letter from the U.S. Food and Drug Administration (FDA) on November 18 following an onsite inspection of Align's corporate headquarters between June 29 and August 9, 2010, and is now working to inform the agency of the steps it has taken in response to the warning letter, the company announced.

December 1, 2010

Infinitt gains FDA nod for simulation software

By DrBicuspid.com staff writers

Xelis Dental -- new simulation software from Infinitt that enables dentists and implantologists to conduct surgical planning -- has received U.S. Food and Drug Administration (FDA) clearance, the company announced.

November 28, 2010

EU to ban bisphenol A in baby bottles in 2011

By Reuters Health

BRUSSELS (Reuters) - The European Union (EU) will ban the use of organic compound bisphenol A (BPA) in plastic baby bottles from 2011 with the backing of a majority of EU governments, the EU's executive Commission said on Thursday.

November 28, 2010

Report: Dental mercury puts millions at risk

By DrBicuspid.com staff writers

A new report submitted by the International Academy of Oral Medicine and Toxicology to the U.S. Food and Drug Administration warns that mercury from dental amalgam restorations is putting millions of Americans at risk.

November 23, 2010

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