Regulatory: Page 15

FDA launches online 510(k) submission tracker
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) has launched a 510(k) submission tracker to enable companies to follow their regulatory submissions to the agency.
August 29, 2021
2019 02 13 19 24 5396 Fda Logo V2 400
FDA warns of poor image quality at NY breast center
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) is warning patients who had mammograms at a radiology center in New York City on or after February 26, 2019, that there were "severe deficiencies" in the image quality of their exams.
August 25, 2021
2019 02 13 19 24 5396 Fda Logo V2 400
ACR takes neutral stance on MARCA legislation
By AuntMinnie.com staff writers
The American College of Radiology (ACR) has decided to neither support nor oppose the Medicare Access to Radiology Care Act (MARCA), legislation pending in the U.S. Congress that would change reimbursement rules for radiologist assistants.
August 24, 2021
2016 10 14 12 22 19 364 Acr Logo 400
Curium files IND application for prostate PET agent
By AuntMinnie.com staff writers
Nuclear medicine firm Curium has submitted an investigational new drug (IND) application to the U.S. Food and Drug Administration for its copper-64 PSMA I&T diagnostic radiopharmaceutical.
August 23, 2021
2019 04 17 20 48 2514 Prostate 3 D 400
FDA warns against use of Echo-Med gels and lotions
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) has warned healthcare providers to immediately stop using and discard all ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical.
August 18, 2021
2018 09 17 23 17 0990 Ultrasound Scan 400
Globus gets FDA clearance for Excelsius3D
By AuntMinnie.com staff writers
Medical device firm Globus Medical has received U.S. Food and Drug Administration (FDA) 510(k) clearance for Excelsius3D, an intraoperative imaging platform that can perform conebeam CT, fluoroscopy, and digital radiography on adult and pediatric patients.
August 16, 2021
2020 02 24 17 44 7728 Clearance Stamp 400
Eco-Med issues voluntary recall of Eco-Gel 200
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration said that Eco-Med Pharmaceuticals has issued a voluntary recall of certain lots of its Eco-Gel 200 ultrasound gel due to contamination from Burkholderia cepacia complex bacteria.
August 5, 2021
2021 08 06 19 02 6992 Ultrasound Gel Probe 400
CMS revokes PET infection, inflammation imaging barrier
By AuntMinnie.com staff writers
The U.S. Centers for Medicare and Medicaid Services (CMS) has removed the final coding barrier for F-18 FDG PET imaging of infection and inflammation, according to the Society of Nuclear Medicine and Molecular Imaging.
August 5, 2021
2019 07 31 17 01 7432 Medicare Puzzle 400
MITA hails radiopharmaceutical legislation
By AuntMinnie.com staff writers
The Medical Imaging & Technology Alliance (MITA) applauded U.S. Senators Marsha Blackburn and Tammy Baldwin for introducing the Facilitating Innovative Nuclear Diagnostics Act of 2021.
August 5, 2021
2021 01 12 21 40 3218 Pet Scanner Bore 400
FDA clears RealView's Holoscope-i holographic system
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) has cleared Israeli 3D holographic display developer RealView Imaging's Holoscope-i medical holographic system.
August 1, 2021
2021 08 03 15 19 2789 2021 08 03 Real View Imaging Holoscope I System 20210803151504
Lantheus subsidiary wins FDA clearance for AI software
By AuntMinnie.com staff writers
Lantheus Holdings announced that its Exini Diagnostics subsidiary was granted U.S. Food and Drug Administration (FDA) 510(k) clearance for its artificial intelligence (AI)-based automated Prostate Cancer Molecular Imaging Standardized Evaluation software.
July 29, 2021
2016 10 04 11 38 34 158 Prostate 400
Medimaps touts reimbursement for trabecular bone scores
By AuntMinnie.com staff writers
Swiss imaging software developer Medimaps said that the U.S. Centers for Medicare and Medicaid Services has set a reimbursement amount for a new category I current procedural terminology code that covers osteoporosis risk fracture assessment via trabecular bone scores.
July 28, 2021
2021 04 06 21 52 3854 Osteoporosis Hip Joint 400
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