Regulatory: Page 74

Fuji SonoSite secures CE Mark for iViz platform
By AuntMinnie.com staff writers
Ultrasound developer Fujifilm SonoSite has received the European CE Mark for iViz, a new ultrasound platform designed for point-of-care settings.
September 20, 2015
Medical groups call for pause to MU program
By AuntMinnie.com staff writers
A coalition of medical societies including the American Medical Association has asked the U.S. government to put on hiatus its meaningful use (MU) program for promoting the adoption of healthcare IT.
September 17, 2015
FDA clears Siemens' full-field digital mammo system
By AuntMinnie.com staff writers
Siemens Healthcare announced that the U.S. Food and Drug Administration (FDA) has cleared the company's Mammomat Fusion full-field digital mammography (FFDM) system.
September 16, 2015
CMS rejects broader payments for NaF-PET
By AuntMinnie.com staff writers
The U.S. Centers for Medicare and Medicaid Services (CMS) has rejected a proposal to loosen the restrictions on reimbursement for sodium fluoride (NaF) PET for detecting cancer that has metastasized to the bone.
September 16, 2015
Duke cardiologist tapped to lead FDA
By AuntMinnie.com staff writers
President Barack Obama has nominated cardiologist Dr. Rob Califf as commissioner of the U.S. Food and Drug Administration (FDA).
September 16, 2015
FDA OKs Medtronic's implantable heart device for MRI
By AuntMinnie.com staff writers
Medtronic has received U.S. Food and Drug Administration (FDA) approval for an implantable cardioverter defibrillator system for use with MRI scanners.
September 13, 2015
DEA removes GE compound as controlled substance
By AuntMinnie.com staff writers
The U.S. Drug Enforcement Administration (DEA) has removed a compound found in GE Healthcare's DaTscan SPECT radiopharmaceutical from the schedules of the Controlled Substances Act, which means the imaging agent will be more widely available to the medical community.
September 13, 2015
Delphinus wins $39.5M in venture capital
By AuntMinnie.com staff writers
Tomographic ultrasound developer Delphinus Medical Technologies has received $39.5 million in venture capital funding.
September 9, 2015
Philips gets FDA nod for spectral CT software
By AuntMinnie.com staff writers
Philips Healthcare has received U.S. Food and Drug Administration (FDA) 510(k) clearance for Spectral Diagnostic Suite, a software suite of advanced visualization and analysis tools available for its IQon spectral CT scanner.
September 8, 2015
U.S. NRC starts review of LNT radiation theory
By AuntMinnie.com staff writers
The U.S. Nuclear Regulatory Commission (NRC) is reviewing the linear no-threshold (LNT) model of the health effects of radiation and the idea that LNT should be replaced with a radiation hormesis model.
September 7, 2015
Surefire gets FDA nod for drug delivery device
By AuntMinnie.com staff writers
Interventional radiology technology developer Surefire Medical has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for Surefire Precision, a new infusion drug delivery device.
August 31, 2015
FDA clears Eizo monitor for breast tomo
By AuntMinnie.com staff writers
Display manufacturer Eizo has received U.S. Food and Drug Administration (FDA) 510(k) clearance for breast tomosynthesis applications on its RadiForce GX540 5-megapixel monochrome LCD monitor.
August 31, 2015
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