Regulatory: Page 104

Siemens gets FDA nod for RT Pro software
By AuntMinnie.com staff writers
Siemens Healthcare said the U.S. Food and Drug Administration has granted 510(k) clearance for the company's RT Pro edition software for enhancing radiation oncology workflow.
January 26, 2014
FDA expands use for Medtronic SureScan
By AuntMinnie.com staff writers
Medtronic has received U.S. Food and Drug Administration approval for use of its SureScan pacing systems with MRI scans positioned on any region of the body.
January 23, 2014
FDA offers committee member nomination portal
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration has launched an advisory committee membership nomination portal.
January 21, 2014
FDA: Breast transilluminators require PMA
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) has issued a final order requiring that a premarket approval (PMA) application be filed for a breast imaging technology called breast transillumination.
January 21, 2014
Varian's ProBeam update gets FDA nod
By AuntMinnie.com staff writers
Radiation therapy firm Varian Medical Systems has received 510(k) clearance from the U.S. Food and Drug Administration for its updated ProBeam proton therapy system.
January 14, 2014
USPSTF posts CT lung cancer screening fact sheet
By AuntMinnie.com staff writers
The U.S. Preventive Services Task Force (USPSTF) has published a fact sheet for primary care doctors on its final recommendation for CT lung cancer screening in high-risk individuals.
January 12, 2014
Breast biopsy payment cuts could revive open surgeries
By Kate Madden Yee
Could open surgical breast biopsy experience a revival? That could be the outcome if deep Medicare cuts to payments for stereotactic breast biopsy procedures are implemented in 2014, according to women's imaging advocates.
January 12, 2014
MITA lauds USPSTF for colon screening review
By AuntMinnie.com staff writers
The Medical Imaging and Technology Alliance (MITA) said it is pleased that the U.S. Preventive Services Task Force (USPSTF) included CT colonography in its draft plan for colon cancer screening released yesterday.
January 9, 2014
USPSTF seeks comments on colon screening plan
By Eric Barnes
In a move that could eventually lead to Medicare reimbursement for virtual colonoscopy screening, the U.S. Preventive Services Task Force (USPSTF) on Thursday opened to public commentary a draft research plan for colorectal cancer screening.
January 9, 2014
FDA clears Delphinus breast US tomography
By AuntMinnie.com staff writers
Delphinus Medical Technologies has received 510(k) clearance from the U.S. Food and Drug Administration for its SoftVue whole-breast ultrasound tomography system.
January 7, 2014
DMS gets FDA nod for R/F table
By AuntMinnie.com staff writers
Diagnostic Medical Systems (DMS) has received U.S. Food and Drug Administration 510(k) clearance for its Platinum remote-controlled radiography/fluoroscopy (R/F) radiology table.
January 6, 2014
USPSTF gives final nod to CT lung cancer screening
By Eric Barnes
After years of discussion and evidence gathering, the U.S. Preventive Services Task Force (USPSTF) this week gave its final approval for annual screening with low-dose CT for individuals at high risk for lung cancer.
December 30, 2013
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