Regulatory: Page 18

CMS to kill payment program for 'breakthrough' medical devices
By Brian Casey
The U.S. Centers for Medicare and Medicaid Services (CMS) is proposing to kill its Medicare Coverage of Innovative Technology program, which was developed under the Trump administration to accelerate Medicare reimbursement for "breakthrough" medical devices.
September 13, 2021
2021 07 30 22 21 1479 Regulation Wheel 400
Siemens secures FDA clearance for Somatom X.ceed
By AuntMinnie.com staff writers
Siemens Healthineers has garnered U.S. Food and Drug Administration (FDA) clearance for its Somatom X.ceed CT scanner.
September 9, 2021
2019 12 03 17 03 9108 Siemens Rsna 2019 400
ASTRO calls proposed CMS cuts 'draconian'
By AuntMinnie.com staff writers
The American Society for Radiation Oncology (ASTRO) told the U.S. Centers for Medicare and Medicaid Services (CMS) that its proposed changes to the 2022 Medicare Physician Fee Schedule could lead to draconian cuts in cancer care.
September 8, 2021
2019 09 16 03 57 7061 Astro 2019 400
Lunit garners regulatory clearance in Singapore
By AuntMinnie.com staff writers
Artificial intelligence software developer Lunit has received clearance from the Health Sciences Authority in Singapore for its Insight CXR and Insight MMG AI software applications.
September 6, 2021
2021 09 07 18 05 3015 Singapore Skyline 400
Radiobotics gets FDA clearance for knee OA algorithm
By AuntMinnie.com staff writers
Artificial intelligence (AI) software developer Radiobotics has secured U.S. Food and Drug Administration 510(k) clearance for RBknee, an AI-based software application designed to aid in the diagnosis of knee osteoarthritis (OA) on radiography.
August 30, 2021
2019 12 09 17 23 6730 Artificial Intelligence Ai Suit 400
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
Previous Page
Page 18 of 305
Next Page