Regulatory: Page 87

FDA OKs HeartFlow FFR-CT software
By AuntMinnie.com staff writers
HeartFlow has received U.S. Food and Drug Administration clearance for its FFR-CT software, which noninvasively estimates fractional flow reserve (FFR) from cardiac CT studies.
November 26, 2014
IRadimed submits 510(k) at FDA request
By AuntMinnie.com staff writers
MRI accessories company IRadimed has submitted a 510(k) application to the U.S Food and Drug Administration (FDA) for its MRidium 3860+ MRI IV infusion pump.
November 26, 2014
Calgary Scientific brings ResolutionMD to Australia
By AuntMinnie.com staff writers
Calgary Scientific has received certification from the Australian Therapeutic Goods Administration for its ResolutionMD image viewing software.
November 25, 2014
Philips lands FDA nod for IQon
By AuntMinnie.com staff writers
Philips Healthcare has received U.S. Food and Drug Administration 510(k) clearance for its IQon spectral CT scanner.
November 25, 2014
InSightec set to bring ExAblate to Japan
By AuntMinnie.com staff writers
MR-guided focused ultrasound (MRgFUS) developer InSightec has received approval from Japan's Ministry of Health, Labor, and Welfare for its ExAblate MRgFUS system.
November 24, 2014
Shimadzu receives Canadian nod for Sonialvision G4
By AuntMinnie.com staff writers
Shimadzu Medical Systems USA has received Health Canada approval for its Sonialvision G4 universal digital radiography/fluoroscopy table.
November 24, 2014
U.S. House passes radiation research bill
By AuntMinnie.com staff writers
The U.S. House of Representatives on November 17 passed the Low-Dose Radiation Research Act of 2014, which is intended to increase understanding of low-dose radiation.
November 17, 2014
TBI reauthorization passes U.S. House
By AuntMinnie.com staff writers
The Traumatic Brain Injury (TBI) Reauthorization Act of 2014 has passed the U.S. House of Representatives, providing money for TBI-related programs through the 2019 fiscal year, according to the Brain Injury Association of America advocacy group.
November 13, 2014
Medtronic gets Japanese clearance for MRI-compatible ICD
By AuntMinnie.com staff writers
Interventional device developer Medtronic announced it has received regulatory approval in Japan to market an implantable cardioverter defibrillator (ICD) that can undergo MRI scans.
November 13, 2014
AMA supports interstate licensure compact
By AuntMinnie.com staff writers
The American Medical Association (AMA) said it supports the interstate medical compact developed by the Federation of State Medical Boards to streamline the process for physicians to obtain licenses in multiple states.
November 10, 2014
CMS includes DBT payment codes in 2015 Medicare rates
By Kate Madden Yee
In a major boost for digital breast tomosynthesis (DBT), the U.S. Centers for Medicare and Medicaid Services (CMS) included payment codes for the exam in its final Medicare Physician Fee Schedule and Hospital Outpatient Prospective Payment System, issued last week.
November 3, 2014
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ACR hopes for good news from CMS on CT lung screening
By Eric Barnes
This November could be the most significant Lung Cancer Awareness Month in history, if Medicare approves full coverage of CT lung cancer screening for seniors 65 years and older, the American College of Radiology (ACR) said in a statement.
November 2, 2014
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