Regulatory Updates: Page 41

Biolux's OrthoPulse gets clearance in Canada
By DrBicuspid.com staff writers
Biolux Research announced that OrthoPulse has received a medical device license from Health Canada and is now commercially available in Canada. The device was cleared as a class II medical device according to the Canadian Medical Device Regulations.
November 24, 2014
Benevis announces certification of EHR system
By DrBicuspid.com staff writers
Benevis, a business support services company for healthcare practices, announced the certification of its Boomerang electronic health records (EHR) system by the Drummond Group's Electronic Health Records Office of the National Coordinator Authorized Certification Body program.
November 23, 2014
NSK Dental receives ISO 13485 certification
By DrBicuspid.com staff writers
Dental equipment manufacturer NSK Dental announced that it has received International Organization for Standardization (ISO) 13485 certification for its North American distribution and repair services. This certification applies specifically to medical device manufacturers.
November 20, 2014
Lymphoseek earns EU marketing authorization
By DrBicuspid.com staff writers
Navidea Biopharmaceuticals announced that it has received marketing authorization in the European Union (EU) for its Lymphoseek 250-mcg kit for radiopharmaceutical preparation.
November 19, 2014
Zimmer, European Commission extend review deadline for Biomet acquisition
By DrBicuspid.com staff writers
Zimmer Holdings announced that it has agreed with the European Commission (EC) to extend the deadline for the EC's review of Zimmer's proposed acquisition of Biomet by a limited number of days to provide the EC with certain additional information.
November 18, 2014
Study warns against using unsafe handheld x-ray devices
By Rabia Mughal
Handheld x-ray devices are used widely in dental practices across the U.S., but are they always safe? That depends on the device, according to a new study in the Journal of the American Dental Association. The study authors warn dental professionals to be cautious and use only those devices that have been cleared by the Food and Drug Administration.
November 11, 2014
2014 11 11 23 33 10 179 Xray Unsafe Device 200
First Do No Harm: Part 2 -- The standard of care in eye protection
By Noel Kelsch, RDHAP
In the second part of this series, Noel Kelsch, RDHAP, writes that successful infection control and clinician safety depend on every clinician being ethical and following laws, regulations, recommendations, and the standard of care.
November 11, 2014
2014 11 14 14 49 22 928 Kelsch Noel 200
Ore. dental board member who faced discipline resigns
By DrBicuspid.com staff writers
A member of the Oregon Board of Dentistry who was facing discipline for allegedly abusing his position and committing other violations has resigned at the governor's request.
November 4, 2014
Calif. malpractice insurance ballot measure fails
By DrBicuspid.com staff writers
A ballot measure that would have quadrupled the cap on noneconomic damages for medical and dental malpractice to $1.1 million was soundly defeated by California voters yesterday by a final margin of 32.9% for the ballot measure and 67.1% against, according to the California Secretary of State's website.
November 4, 2014
2014 11 06 10 33 19 302 No Check Vote 200
Ocean Dental to pay $5.05M in Medicaid fraud settlement
By DrBicuspid.com staff writers
Oklahoma-based Ocean Dental has agreed to pay $5.05 million to settle Medicaid fraud claims, according to a release from the U.S. Attorney's Office for the Western District of Oklahoma and the state's attorney general.
November 3, 2014
NJ bill would prohibit insurers from fee capping
By DrBicuspid.com staff writers
Late last week, New Jersey's General Assembly took the latest step in a years-old dispute between insurers and the state dental association when it approved bill A-3411.
October 26, 2014
ADA offers new online practice management courses
By DrBicuspid.com staff writers
The ADA's Center for Professional Success is offering a new online Executive Program in Dental Practice Management, consisting of six 10-hour courses in which dentists can learn about financial management, enhancing marketing strategies, practicing amid increased regulation, and other topics.
October 23, 2014
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