Regulatory: Page 10

FDA issues new draft cybersecurity guidance
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) has issued a new draft guidance addressing cybersecurity in medical devices.
April 6, 2022
2016 09 02 09 36 05 93 Fda Logo V2 400
CMS again delays start of RO Model for radiation therapy payments
By Brian Casey
A major restructuring of the way the U.S. Centers for Medicare and Medicaid Services (CMS) pay for radiation therapy treatments, the Radiation Oncology Alternative Payment Model (RO Model), has been delayed again -- this time into the indefinite future.
April 5, 2022
2018 11 14 23 24 9873 Radiation Therapy Suite 400
Aidoc gets FDA nod for pneumothorax AI triage software
By AuntMinnie.com staff writers
Artificial intelligence (AI) software developer Aidoc has received U.S. Food and Drug Administration (FDA) 510(k) clearance for AI-based software used for triage and notification of pneumothorax on x-ray exams. The software is Aidoc's first non-CT application.
March 30, 2022
2019 10 21 17 41 6509 Artificial Intelligence Ai Suit 400
FDA issues warning on iodinated contrast use in young kids
By Brian Casey
The U.S. Food and Drug Administration (FDA) has added a new warning to the prescribing information for iodinated contrast media, advising of the health risk of contrast use in children younger than 3 years who have thyroid issues.
March 29, 2022
2019 02 13 19 24 5396 Fda Logo V2 400
Oxipit secures CE Mark for autonomous imaging AI
By AuntMinnie.com staff writers
Artificial intelligence (AI) software developer Oxipit's ChestLink software for chest x-rays has received the CE Mark in Europe. The software autonomously reports on imaging studies without the involvement of a radiologist.
March 28, 2022
2019 04 04 21 52 2230 Artificial Intelligence Ai Data 400
FDA approves Lu-177 PSMA-617 for prostate cancer treatment
By Will Morton
The U.S. Food and Drug Administration (FDA) has approved lutetium-177 (Lu-177) prostate-specific membrane antigen radioligand therapy for the treatment of patients with metastatic prostate cancer.
March 22, 2022
2019 02 13 19 24 5396 Fda Logo V2 400
MedTrace Pharma prepares phase III trial for O-15 PET
By AuntMinnie.com staff writers
Danish PET technology developer MedTrace Pharma has received an investigational new drug exemption from the U.S. Food and Drug Administration, paving the way for a clinical trial to assess the firm's radioactive water (oxygen-15 water) PET imaging technique in detecting coronary artery disease.
March 21, 2022
2017 02 10 15 45 57 410 Heart 400
Cybersecurity vulnerability ensnares imaging, radiation therapy firms
By Erik L. Ridley
Cybersecurity vulnerabilities in remote connectivity software used in service offerings by several medical imaging and radiation therapy firms could allow attackers to take control of connected systems, according to alerts issued by U.S. government agencies.
March 9, 2022
2019 03 26 18 32 2300 Computer Hacker Security 400
ACR urges Congress to extend Medicare payment cut delay
By AuntMinnie.com staff writers
The American College of Radiology (ACR) is joining in an effort to urge Congress to further delay looming Medicare payment cuts.
March 6, 2022
2016 10 14 12 22 19 364 Acr Logo 400
Coverage is expanded for CT lung cancer screening
By Sandy Coffta
The U.S. Centers for Medicare and Medicaid Services has announced a shift in its eligibility criteria for coverage of lung cancer screening using low-dose CT. Sandy Coffta of Healthcare Administrative Partners USA explains the changes.
February 24, 2022
2017 12 20 17 16 6396 Lung General 400
MITA applauds FDA for AI medical device principles
By AuntMinnie.com staff writers
The Medical Imaging & Technology Alliance (MITA) recently applauded principles co-authored by the U.S. Food and Drug Administration (FDA) for best practices on medical devices that use artificial intelligence (AI) and machine learning.
February 17, 2022
2019 10 21 17 41 6509 Artificial Intelligence Ai Suit 400
ACR seeks changes to FDA paper on 3D printing
By AuntMinnie.com staff writers
The American College of Radiology (ACR) has recommended several changes to a discussion paper issued by the U.S. Food and Drug Administration (FDA) in December on the use of 3D-printed medical devices.
February 16, 2022
2016 10 14 12 22 19 364 Acr Logo 400
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