Regulatory Updates: Page 32

FDA reclassifies salivary stimulator system
By DrBicuspid.com staff writers
The U.S. Food and Drug Administration (FDA) issued a final order on November 20 to reclassify and rename what has been known as a salivary stimulator system.
November 19, 2015
Vigilant gets CE Mark for oral cancer test
By DrBicuspid.com staff writers
Vigilant Biosciences' OncAlert oral cancer CD44/total protein lab test has received the CE Mark, which allows the company to market the test in Europe.
November 15, 2015
U.S. federal court rules in favor of ClearCorrect over ITC
By Theresa Pablos
A U.S. federal court has ruled in favor of ClearCorrect in a case involving digital data, noting that the U.S. International Trade Commission does not have the authority to regulate the data. The case has implications that could affect how the Internet is regulated.
November 11, 2015
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Collagen Matrix to participate in FDA learning program
By DrBicuspid.com staff writers
Collagen Matrix announced that the company has been selected to participate in the U.S. Food and Drug Administration (FDA) Experiential Learning Program.
November 11, 2015
ADA 2015: Solea gets FDA clearance for new procedures
By DrBicuspid.com staff writers
WASHINGTON, DC - Convergent Dental announced at the 2015 ADA meeting in Washington, DC, that its Solea dental laser has been cleared by the U.S. Food and Drug Administration (FDA) to perform osseous tissue procedures.
November 4, 2015
Nanova's NovaPro Flow composite gets FDA clearance
By DrBicuspid.com staff writers
Nanova Biomaterials' NovaPro Flow composite has received clearance from the U.S. Food and Drug Administration (FDA) for commercial distribution.
October 20, 2015
FTC weighs in on dental boards after Supreme Court ruling
By Tony Edwards, Donna Domino
In response to February's U.S. Supreme Court ruling against the North Carolina dental board in the teeth-whitening case, the Federal Trade Commission (FTC) recently issued guidance on how state regulatory boards controlled by market participants can avoid antitrust litigation.
October 15, 2015
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Dr. Califf nominated to head FDA, HHS
By DrBicuspid.com staff writers
President Barack Obama announced that he will nominate Robert Califf, MD, to head the U.S. Food and Drug Administration (FDA) and the Department of Health and Human Services (HHS).
September 15, 2015
HHS proposes protections for transgender people
By DrBicuspid.com staff writers
The U.S. Department of Health and Human Services (HHS) proposed a rule on September 3 that prohibits discrimination based on sex, including gender identity.
September 7, 2015
Biolux's Orthopulse gets FDA clearance
By DrBicuspid.com staff writers
Biolux Research's OrthoPulse has received 510(k) marketing clearance from the U.S. Food and Drug Administration (FDA), the company announced.
July 30, 2015
FDA clears DentiTrac system
By DrBicuspid.com staff writers
Braebon Medical announced that the DentiTrac oral-appliance compliance system has been cleared by the U.S. Food and Drug Administration (FDA) for use with the SomnoDent oral device.
June 25, 2015
ACA challenge rejected by U.S. Supreme Court
By Tony Edwards
The Patient Protection and Affordable Care Act (ACA) has survived another U.S. Supreme Court test, with a 6-3 vote on Thursday allowing the federal government's online health insurance exchange to continue.
June 24, 2015
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