Regulatory: Page 76

ISO certification: Why it's important to you
By Larry Nguyen
While medical device companies often tout International Organization for Standardization (ISO) certifications, potential customers may not understand what these certifications actually prove. But a little due diligence can clear up any uncertainty, writes Summit Imaging CEO Larry Nguyen.
October 8, 2015
2015 10 08 15 34 19 856 Nguyen Larry 200
FDA clears ECG readings on Carestream's Vue Motion
By AuntMinnie.com staff writers
Carestream Health has received clearance from the U.S. Food and Drug Administration (FDA) for diagnostic reading of electrocardiograms (ECGs) on desktop displays and mobile tablets using its Vue Motion viewer.
October 7, 2015
U.S. government finalizes meaningful use regulations
By Erik L. Ridley
With the goal of making its meaningful use IT stimulus initiative simpler and more flexible for providers, the U.S. government has issued final rules for its incentive and certification program for electronic health record software.
October 7, 2015
2015 10 07 16 49 08 80 Computer Stethoscope 200
Advocates for NaF-PET plan rebound from CMS decision
By Wayne Forrest
In a word, "disappointment" is how members of the nuclear medicine and radiology communities are reacting to last month's rejection by the U.S. Centers for Medicare and Medicaid Services (CMS) of a proposal to loosen restrictions on reimbursement for sodium fluoride (NaF) PET scans to detect bone metastases.
October 7, 2015
2015 10 07 15 55 03 265 No Check Vote 200
Varian gets regulatory clearance for VitalBeam
By AuntMinnie.com staff writers
Radiation therapy firm Varian Medical Systems has received 510(k) clearance from the U.S. Food and Drug Administration and the European CE Mark for its VitalBeam radiation therapy system.
October 6, 2015
ONC finalizes interoperability road map
By AuntMinnie.com staff writers
The U.S. Department of Health and Human Services' Office of the National Coordinator for Health Information Technology (ONC) has released version 1.0 of its road map for achieving the interoperability of health IT.
October 6, 2015
Hitachi gets FDA nod for Supria CT scanner
By AuntMinnie.com staff writers
Hitachi Medical Systems America has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Supria 16-slice CT scanner.
October 6, 2015
ACR slams USPSTF decision on CT colonography
By AuntMinnie.com staff writers
The American College of Radiology (ACR) said the decision by the U.S. Preventive Services Task Force (USPSTF) not to include CT colonography on its list of recommended colorectal cancer screening exams may result in thousands of unnecessary deaths as well as needless healthcare spending.
October 6, 2015
USPSTF foils CT colonography screening again
By Eric Barnes
In a draft recommendation released today, the U.S. Preventive Services Task Force (USPSTF) appears to have thrown CT colonography under the bus again, excluding the CT-based exam from its list of recommended colorectal cancer screening tests.
October 5, 2015
2015 10 06 11 21 00 863 Denied 200
Staff shortages plague Ariz. radiation agency
By AuntMinnie.com staff writers
The Arizona agency charged with regulating x-ray facilities in the state has fallen behind on site inspections because of a shortage of trained personnel, according to a report issued last week.
October 4, 2015
Canada renews Nordion's nuclear processing license
By AuntMinnie.com staff writers
The Canadian Nuclear Safety Commission has renewed radioisotope firm Nordion's license for operating a nuclear substance processing facility.
October 4, 2015
PETNet gets approval for PET agent
By AuntMinnie.com staff writers
PETNet Solutions has received approval from the U.S. Food and Drug Administration (FDA) for an abbreviated new drug application for its sodium fluoride F-18 radiopharmaceutical.
October 1, 2015
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