Regulatory: Page 43

InSightec submits PMA to Japan for Exablate device
By AuntMinnie.com staff writers
MR-guided focused ultrasound developer InSightec has submitted a premarket approval (PMA) application to the Japanese Pharmaceuticals and Medical Devices Agency for its Exablate Neuro (Exablate 4000) device.
May 13, 2018
CFDA drafts guidance on 3D-printed medical devices
By AuntMinnie.com staff writers
The China Food and Drug Administration (CFDA) has released a draft guidance covering the regulation of customized 3D-printed medical devices.
May 10, 2018
2016 10 18 16 55 18 858 Chinese Flag Button 400
Change of MPPR from 25% to 5% benefits CT the most
By Kate Madden Yee
Areas of radiology that rely on CT stand to benefit the most from adjustments to the multiple procedure payment reduction (MPPR) of the professional component, according to research delivered at the recent American Roentgen Ray Society meeting in Washington, DC, and published in the April American Journal of Neuroradiology.
May 9, 2018
2018 05 04 22 17 6629 Ct Scanner 400
FDA posts alert for NC mammography facility
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) has filed an adverse event report for a North Carolina mammography facility.
May 8, 2018
Calif. women want breast density law to stay
By AuntMinnie.com staff writers
California women want their state's breast density notification law to stay on the books, according to a survey conducted by Are You Dense Advocacy.
May 7, 2018
FDA issues new labeling for gadolinium contrast
By Wayne Forrest
The U.S. Food and Drug Administration (FDA) in April published revised product labeling for linear and macrocyclic gadolinium-based contrast agents. The new labeling includes a section on gadolinium retention.
May 2, 2018
2016 09 02 09 36 05 93 Fda Logo V2 400
Miss. Supreme Court orders Medicaid to make payments
By AuntMinnie.com staff writers
On April 12, the Mississippi Supreme Court ordered the state's Medicaid program to pay $2 million to 12 hospitals due to inadequate reimbursement for radiology and laboratory services, according to a report published by the Clarion Ledger.
April 29, 2018
FDA works on new regulatory framework for AI
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) is working on a new regulatory framework aimed at encouraging the use of artificial intelligence (AI) in healthcare, according to a report from the Hill.
April 26, 2018
2016 09 02 09 36 05 93 Fda Logo V2 400
Carestream nets Canadian license for OnSight 3D
By AuntMinnie.com staff writers
Carestream Health has secured a class III license from Health Canada for its Carestream OnSight 3D conebeam CT extremity scanner.
April 26, 2018
FDA issues MR thermometry warning
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) has issued a safety alert regarding the reliability of MR thermometry with MRI-guided laser interstitial thermal therapy devices.
April 25, 2018
2016 09 02 09 36 05 93 Fda Logo V2 400
CMS proposes overhaul of meaningful use program
By Erik L. Ridley
The U.S. Centers for Medicare and Medicaid Services (CMS) has proposed a number of changes to its Inpatient Prospective Payment System and the Long-Term Care Hospital Prospective Payment System for 2019, including renaming and overhauling its meaningful use IT stimulus program.
April 24, 2018
2018 03 19 17 22 4825 Doctor Computer 400
MITA expands scope of standards document
By AuntMinnie.com staff writers
The Medical Imaging and Technology Alliance (MITA) said it is expanding the scope of its NEMA American National Standard for Servicing of Medical Imaging Devices to cover all medical devices, not just medical imaging technologies.
April 23, 2018
Previous Page
Page 43 of 302
Next Page