Regulatory: Page 129

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
Volcano to acquire Crux Biomedical
By AuntMinnie.com staff writers
Intravascular ultrasound developer Volcano has signed an agreement to acquire Crux Biomedical for $36 million in cash.
December 2, 2012
Health Canada issues thermography warning
By AuntMinnie.com staff writers
Health Canada has issued a warning on thermography-based breast imaging to Canadian citizens and healthcare providers.
November 29, 2012
Bracco issues recall of Isovue prefilled syringes
By AuntMinnie.com staff writers
Bracco Diagnostics has issued a voluntary recall of nine lots of Isovue (iopamidol injection) prefilled power injector syringes.
November 26, 2012
Neusoft gets FDA OK for NeuViz 64
By AuntMinnie.com staff writers
Chinese medical equipment manufacturer Neusoft Medical Systems has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its NeuViz 64 multislice CT scanner, the company announced.
November 26, 2012
FDA clears TomTec's Image-Com 5.0 software
By AuntMinnie.com staff writers
Imaging software developer TomTec Imaging Systems has received 501(k) clearance from the U.S. Food and Drug Administration for its Image-Com 5.0 software.
November 19, 2012
GE's Freedom CT nets Health Canada OK
By AuntMinnie.com staff writers
GE Healthcare has received clearance from Health Canada for its new cardiac imaging platform, Discovery CT750 HD Freedom Edition.
November 15, 2012
ONC launches database for applicants to workgroups
By AuntMinnie.com staff writers
The U.S. Office of the National Coordinator for Health IT (ONC) has launched a new application database for individuals interested in being a member of its HIT standards committee and HIT policy committee.
November 15, 2012
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