Regulatory: Page 125

CDRH updates radiation program information
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration's Center for Devices and Radiological Health (CDRH) has added updated information about its programs to its website.
December 18, 2012
Navidea submits Lymphoseek application to EMA
By AuntMinnie.com staff writers
Radiopharmaceutical developer Navidea Biopharmaceuticals has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for its investigational radiopharmaceutical Lymphoseek injection, an intraoperative lymphatic mapping agent.
December 18, 2012
MITA lauds CMS PET tracer proposal
By AuntMinnie.com staff writers
The Medical Imaging and Technology Alliance (MITA) is lauding the proposal by the U.S. Centers for Medicare and Medicaid Services (CMS) to remove the national noncoverage decision for PET with radiopharmaceuticals for U.S. Food and Drug Administration-approved oncologic applications.
December 17, 2012
MITA survey warns of medical device tax impact
By AuntMinnie.com staff writers
The medical device excise tax set to go into effect on January 1, 2013, in the U.S. may force up to 41% of medical device manufacturers to reduce their U.S. workforces, according to a survey by the Medical Imaging and Technology Alliance (MITA).
December 17, 2012
Elekta gets FDA OK for monitoring software
By AuntMinnie.com staff writers
Radiation oncology firm Elekta has received U.S. Food and Drug Administration 510(k) clearance for its Clarity 4D monitoring software, which monitors motion in the prostate and surrounding tissues and organs during radiation therapy for prostate cancer.
December 16, 2012
CMS proposal could ease payment path for oncology PET tracers
By Wayne Forrest
The U.S. Centers for Medicare and Medicaid Services (CMS) this week proposed a new policy that could make it easier for new oncology PET tracers to win reimbursement. PET advocates are disappointed, however, that the change won't apply to tracers used for neurology and cardiology applications.
December 13, 2012
Breast density notification bill introduced in Ohio
By AuntMinnie.com staff writers
Legislation that would require healthcare providers to notify women of their breast density status has been introduced in Ohio.
December 13, 2012
HHS launches health info education initiative
By AuntMinnie.com staff writers
The U.S. Department of Health and Human Services (HHS) has launched a new education initiative to provide healthcare providers and organizations with practical tips on ways to protect their patients' health information when using mobile devices such as laptops, tablets, and smartphones.
December 11, 2012
Devicor gets FDA nod for Mammotome revolve
By AuntMinnie.com staff writers
Breast cancer treatment technology provider Devicor Medical Products has received U.S. Food and Drug Administration clearance for Mammotome revolve, a new dual vacuum-assisted biopsy system.
December 11, 2012
Medical Metrics signs on for FDA hip implant study
By AuntMinnie.com staff writers
Imaging core lab services provider Medical Metrics said it has been selected by five orthopedic device manufacturers to support multiple cross-sectional postmarket surveillance studies of metal-on-metal hip implants.
December 11, 2012
FDA gives PET drugmakers until 2015 to comply with new rules
By Wayne Forrest
The U.S. Food and Drug Administration this week set a December 12, 2015, deadline for PET drug manufacturers to operate under an approved new drug application (NDA), abbreviated new drug application (ANDA), or investigational new drug (IND) submission to continue to make their products.
December 5, 2012
MITA to Congress: Delay device tax
By AuntMinnie.com staff writers
The Medical Imaging and Technology Alliance (MITA) has called on Congress to delay implementation of the medical device excise tax, in response to regulations released by the Internal Revenue Service and the U.S. Treasury Department, which do not provide time for MITA member companies to comply with the requirements, the organization said.
December 4, 2012
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