Regulatory: Page 23

RadioMedix, Curium win FDA clearance for Detectnet
By AuntMinnie.com staff writers
Biotechnology firm RadioMedix and global nuclear medicine firm Curium have received U.S. Food and Drug Administration (FDA) clearance for their Detectnet PET diagnostic radiopharmaceutical copper-64 DOTATATE.
September 7, 2020
2020 02 20 00 48 1332 Approved Stamp 400
Japan to pay for Insightec MRgFUS for Parkinson's
By AuntMinnie.com staff writers
MR-guided focused ultrasound (MRgFUS) developer Insightec said that the Japanese Ministry of Health, Labor, and Welfare will provide reimbursement for the use of its Exablate Neuro device in treating Parkinson's disease.
September 1, 2020
2020 09 02 18 40 1978 Parkinsons Definition 400
GE brings Critical Care Suite to Canada
By AuntMinnie.com staff writers
GE Healthcare has received a license from Health Canada for its Critical Care Suite of artificial intelligence algorithms for chest x-rays.
September 1, 2020
2020 01 29 18 12 5932 Ge Rsna 2019 400
Topol blasts FDA chief Hahn on blood plasma approval
By AuntMinnie.com staff writers
Cardiologist and healthcare gadfly Dr. Eric Topol leveled a blistering critique at U.S. Food and Drug Administration (FDA) chief Dr. Stephen Hahn over the agency's approval of a blood plasma treatment for COVID-19. Topol accused Hahn of politicizing the agency and suggested he should resign.
August 31, 2020
2019 11 01 22 16 2253 Hahn Stephen 20191101221734
Contrast group asks FDA to pull 'black box' warning
By AuntMinnie.com staff writers
A group representing users of ultrasound contrast agents on August 31 asked the U.S. Food and Drug Administration (FDA) to pull its longstanding "black box" warning on the label of contrast agents.
August 31, 2020
2019 04 02 18 59 1354 Ultrasound Probe Vascular 400
Radiology's declining reimbursement spans over a decade
By Sandy Coffta
The average cut of 11% in radiology reimbursement that is proposed by the Medicare Physician Fee Schedule for 2021 is the continuation of a trend that spans more than a decade. Sandy Coffta of Healthcare Administrative Partners explains.
August 24, 2020
2017 04 03 18 01 52 418 Graph Arrow Down 400
CMS to resume routine inspections
By AuntMinnie.com staff writers
The U.S. Centers for Medicare and Medicaid Services (CMS) said on August 17 that it will resume routine inspections of healthcare providers and suppliers that had been suspended during the COVID-19 outbreak.
August 17, 2020
2020 07 22 22 57 7185 Coronavirus Business Graphic 400
Medicare proposes major cut to radiology for 2021
By Sandy Coffta
The U.S. Centers for Medicare and Medicaid Services has released its annual proposal for changes to the Medicare payment system for the coming year. The changes include cuts to radiology payments, according to Sandy Coffta of Healthcare Administrative Partners.
August 17, 2020
2020 04 23 23 09 1336 Graph Market Down 400
Thermal burns top FDA list of MRI adverse event reports
By Wayne Forrest
Ten years of MRI adverse event reports show burns from coils and electrocardiography leads during scans are among the most common -- and preventable -- causes for patient injuries, according to a study presented Thursday at the International Society for Magnetic Resonance in Medicine meeting.
August 12, 2020
2018 08 30 21 08 1300 Safety First 400
CMS postpones 'appropriate use' mandate past 2021
By Brian Casey
Clinicians ordering advanced imaging scans like CT, MRI, and PET in the Medicare system will no longer have to use appropriate use criteria (AUC) and decision support starting in 2021. On August 10, the U.S. Centers for Medicare and Medicaid Services (CMS) said it was extending the testing period for AUC through the end of 2021.
August 10, 2020
2019 11 13 00 46 2926 Business Deal Corporate 400
MITA opposes new bill on repairing medical devices
By AuntMinnie.com staff writers
The Medical Imaging & Technology Alliance (MITA) has come out against legislation that would change federal laws on service of medical devices.
August 6, 2020
2020 06 18 21 26 1731 Service Repair 400
Early pandemic funding sources may require action now
By Rebecca Farrington
What's going on with some of the other sources for COVID-19 relief funding that are available? Rebecca Farrington of Healthcare Administrative Partners reviews some of the options.
August 6, 2020
2020 07 31 22 16 0362 Dollar Money Coronavirus Mask 400
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