Regulatory: Page 112

Helium bill floats over final hurdle in Congress
By AuntMinnie.com staff writers
Legislation that would prevent the U.S. from going over a "helium cliff" cleared a final obstacle on September 26 and will go on to President Barack Obama for his signature.
September 26, 2013
FDA guidance on mobile apps offers clarity to developers
By Erik L. Ridley
The U.S. Food and Drug Administration's release on Monday of its long-awaited final guidance on mobile medical applications was designed to address market confusion over its policy for regulating these apps. While some questions remain, the guidance offers app developers a path forward in determining how to secure regulatory clearance for their products.
September 25, 2013
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IBA seeks FDA approval for proton therapy gantry system
By AuntMinnie.com staff writers
Radiopharmaceutical firm IBA Molecular has submitted documentation to the U.S. Food and Drug Administration for a compact proton therapy gantry.
September 23, 2013
Given's PillCam approved in Japan
By AuntMinnie.com staff writers
Video-capsule developer Given Imaging has been given the green light for its PillCam SB 3 system in Japan.
September 23, 2013
FDA mobile medical apps guidance includes radiology apps
By Erik L. Ridley
More than two years after it issued a draft proposal, the U.S. Food and Drug Administration on Monday released its final guidance on the regulation of mobile medical applications for developers. Radiology-oriented apps figure prominently in the examples of mobile apps the agency said it intends to regulate.
September 22, 2013
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FDA finalizes new UDI system to identify devices
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration on September 20 issued a final rule that implements its unique device identification (UDI) system.
September 19, 2013
MITA lauds Senate passage of helium bill
By AuntMinnie.com staff writers
The Medical Imaging and Technology Alliance (MITA) said it supports the U.S. Senate passage of legislation to keep the Federal Helium Reserve open.
September 19, 2013
GE touts ABUS study
By AuntMinnie.com staff writers
GE Healthcare is pointing to a recent study that showed that radiologists using automated breast ultrasound (ABUS) had high interreader agreement.
September 19, 2013
CMS: U.S. healthcare spending to rebound after 2014
By Kate Madden Yee
Healthcare spending in the U.S. is expected to rebound between 2014 and 2022 to growth rates seen prior to the recent economic slowdown. Rates will be higher than in the recent past but lower compared to longer-term historical growth, according to a report published online September 18 in Health Affairs.
September 17, 2013
Matakina registers VolparaAnalytics with FDA
By AuntMinnie.com staff writers
Breast imaging software developer Matakina International announced registration of its new class I software medical device, VolparaAnalytics, with the U.S. Food and Drug Administration.
September 17, 2013
Fla. radiation oncologists pay $3.5M settlement
By AuntMinnie.com staff writers
Two radiation oncologists in Pensacola, FL, will pay $3.5 million to the government and the state of Florida to resolve Medicare fraud allegations, according to the U.S. Department of Justice.
September 17, 2013
CBO: House SGR fix comes with 26% higher price tag
By Kate Madden Yee
A bill passed in August out of a U.S. House of Representatives committee that would repeal the Medicare sustainable growth rate (SGR) formula may soon hit another obstacle as it proceeds on its legislative journey: a higher price tag.
September 15, 2013
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