Regulatory: Page 21

FDA approves 1st PSMA-targeting PET radiotracer for prostate cancer
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) has approved the first PET radiotracer targeting lesions positive for prostate-specific membrane antigen (PSMA) in men with prostate cancer, a development the agency believes has important implications for patient care.
November 30, 2020
2016 09 02 09 36 05 93 Fda Logo V2 400
Atlas resigns as White House COVID-19 adviser
By Brian Casey
Neuroradiologist Dr. Scott Atlas on November 30 announced his resignation as an adviser on COVID-19 to the Trump administration. Atlas' four-month tenure in the position was marked by controversy due to statements he made in opposition to lockdown measures.
November 30, 2020
2017 01 31 10 30 03 605 White House 400
Braid Health gets FDA nod for collaboration software
By AuntMinnie.com staff writers
Radiology artificial intelligence (AI) diagnostic platform developer Braid Health has garnered U.S. Food and Drug Administration (FDA) clearance for its AI-powered diagnostic collaboration platform.
November 23, 2020
2020 07 07 20 07 3793 Global Collaboration Business 400
CMS issues final rule modernizing Stark law
By Brian Casey
Saying it is lifting the weight of "punishing bureaucracy" from the backs of physicians, the U.S. Centers for Medicare and Medicaid Services (CMS) on November 20 announced its final rule implementing major changes to the Stark law, a set of federal rules that prohibit physicians from self-referral.
November 19, 2020
2016 08 25 13 38 02 14 Money Dollar Bandaid 400
AI Metrics wins FDA nod for liver biopsy software
By AuntMinnie.com staff writers
Artificial intelligence (AI) software developer AI Metrics has garnered U.S. Food and Drug Administration (FDA) 510(k) clearance for its Liver Surface Nodularity virtual liver biopsy software.
November 16, 2020
2019 05 29 19 22 3353 Liver Anatomy 400
Atlas urges Michigan to 'rise up' against COVID-19 rules
By Brian Casey
Neuroradiologist and White House COVID-19 adviser Dr. Scott Atlas is drawing criticism for statements he made on Twitter over the weekend urging Michigan residents to "rise up" against lockdown rules designed to prevent the spread of COVID-19 in the state.
November 15, 2020
2020 11 10 23 17 2552 3d Closeup Coronavirus 400
Axonics files PMA supplement for further MRI labeling
By AuntMinnie.com staff writers
Axonics Modulation Technologies has filed a premarket approval (PMA) supplement with the U.S. Food and Drug Administration to secure clearance for detachable extremity coil MRI conditional labeling for its implantable sacral neuromodulation device on 1.5-tesla and 3-tesla scanners.
October 28, 2020
2019 02 13 19 24 5396 Fda Logo V2 400
USPSTF proposes lowering colon screening age to 45
By AuntMinnie.com staff writers
Colon cancer screening should begin at age 45 instead of 50, according to a draft proposal issued October 27 by the U.S. Preventive Services Task Force (USPSTF).
October 28, 2020
2020 10 28 23 49 6025 Colon Polyps 400
Siemens receives FDA clearance for Ysio X.pree
By AuntMinnie.com staff writers
Siemens Healthineers has garnered U.S. Food and Drug Administration (FDA) clearance for Ysio X.pree, the firm's new premium digital radiography system.
October 26, 2020
2020 06 18 23 18 8611 Siemens Ysio X pree 2 Thumbnail
FDA clears Aidoc's incidental PE AI algorithm
By AuntMinnie.com staff writers
Artificial intelligence (AI) software developer Aidoc has garnered U.S. Food and Drug Administration (FDA) clearance for its computer-assisted triage technology in flagging and notification of incidental pulmonary embolism (PE) on CT scans.
October 21, 2020
2020 10 21 15 11 6219 2020 10 21 Aidoc 20201021151520
Quantib wins FDA clearance for prostate MRI AI software
By AuntMinnie.com staff writers
Artificial intelligence (AI) software developer Quantib has garnered U.S. Food and Drug Administration (FDA) clearance for an AI application designed to assist radiologists in interpreting prostate MRI exams.
October 21, 2020
2020 10 21 01 09 2843 2020 10 21 Quantib 400
CMS to delay start of RO Model for radiation therapy
By Brian Casey
The radiation oncology community has cause for celebration as the U.S. Centers for Medicare and Medicaid Services (CMS) decided to postpone for six months the implementation of its Radiation Oncology (RO) Model, a controversial new method of paying for radiation therapy treatments.
October 20, 2020
2016 08 22 10 18 31 293 Money Belt Tighten 400
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