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Regulatory: Page 31
HHS offers changes to self-referral, kickback laws
By
AuntMinnie.com staff writers
The U.S. Department of Health and Human Services (HHS) is proposing rule changes to the current physician self-referral law and the federal antikickback statute.
October 9, 2019
FDA offers guidance on coated devices
By
AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) has issued a guidance document on what labeling and other information should be included when submitting premarket applications (PMAs) and 510(k) clearance applications for coated implantable medical devices.
October 9, 2019
FDA clears ProTom's Radiance proton therapy system
By
AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) has cleared proton therapy developer ProTom International's Radiance 330 single-room proton therapy system.
October 6, 2019
FDA issues new cybersecurity warning
By
AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) has issued a safety communication on the potential risks for medical devices -- including imaging systems -- and hospital networks from the so-called Urgent/11 cybersecurity vulnerabilities.
October 1, 2019
CMS gets pushback on PET fee cuts
By
AuntMinnie.com staff writers
Imaging organizations opposing the U.S. Centers for Medicare and Medicaid Services' (CMS) proposed payment reductions related to myocardial PET equipment and services have received support from 43 members of Congress.
October 1, 2019
ACR urges CMS not to reallocate payments for E/M
By
AuntMinnie.com staff writers
The American College of Radiology (ACR) is asking the Centers for Medicare and Medicaid Services (CMS) to drop a proposed policy that would shift payments within the Medicare Physician Fee Schedule (MPFS) for 2021 toward evaluation and management (E/M) services.
October 1, 2019
USP delays revised radiopharmaceutical standards
By
AuntMinnie.com staff writers
The U.S. Pharmacopeial Convention (USP) has postponed until December 1 implementation of several revisions related to the compounding, preparation, and packaging of radiopharmaceuticals.
September 25, 2019
FDA seeks patient engagement in device design, development
By
AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) has published draft guidance on how device manufacturers should engage patients when designing medical devices.
September 23, 2019
Varian gets USTR tariff exemption for linear accelerators
By
AuntMinnie.com staff writers
The U.S. Trade Representative (USTR) has granted radiation therapy firm Varian Medical Systems an exclusion from U.S. trade tariffs for linear accelerator components manufactured in China, effective September 20.
September 22, 2019
Technologist licensure bill introduced in Pa.
By
AuntMinnie.com staff writers
A bill that would require licensure for medical imaging and radiation therapy technologists has been introduced in the Pennsylvania Legislature, according to the Society of Nuclear Medicine and Molecular Imaging (SNMMI).
September 22, 2019
Canada's Conservatives pledge $1.5B in imaging funds
By
Louise Gagnon
OTTAWA, ONTARIO - Long wait times in Canada for medical imaging procedures could be cut dramatically -- at least, if the Conservative Party follows through on an election pledge made today to invest $1.5Â billion Canadian in new MRI and CT scanners.
September 19, 2019
FDA releases final guidance for special 510(k) process
By
AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) has released a final guidance on its Special 510(k) program.
September 11, 2019
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