Regulatory: Page 13

Provider relief fund reporting extensions are available
By Rebecca Farrington
Is your radiology practice looking for an extension on the reporting requirements involved in receiving grants under the U.S. government's Provider Relief Funds program? If so, Rebecca Farrington of Healthcare Administrative Partners offers some guidance.
April 25, 2022
2020 07 31 22 16 0362 Dollar Money Coronavirus Mask 400
FDA patient committee to discuss virtual reality technology
By AuntMinnie.com staff writers
A committee of the U.S. Food and Drug Administration (FDA) that represents the interests of patients plans to meet in July to discuss medical devices that use augmented reality and virtual reality.
April 12, 2022
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FDA says AI doesn't exclude LVO cases from radiologist review
By Brian Casey
Artificial intelligence (AI) software shouldn't be used to rule out cases of intracranial large-vessel occlusion (LVO) from radiologist review, according to an advisory issued April 11 by the U.S. Food and Drug Administration.
April 10, 2022
2019 11 22 20 38 5687 Computer Brain Ai 400
CMS criticized for final decision on Aduhelm reimbursement
By Will Morton
The U.S. Centers for Medicare and Medicaid Services (CMS) finalized a plan April 7 that limits coverage of Biogen's Alzheimer's disease drug Aduhelm only to patients enrolled in clinical trials, despite pressure from the Society of Nuclear Medicine and Molecular Imaging and other groups to expand coverage of the drug.
April 7, 2022
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CMS finalizes rule on limited payment for Alzheimer's drugs
By AuntMinnie.com staff writers
The U.S. Centers for Medicare and Medicaid Services (CMS) has issued a final national coverage determination that limits coverage for Alzheimer's monoclonal antibody drugs like aducanumab only to people enrolled in qualifying clinical trials.
April 6, 2022
2020 06 15 23 55 8696 Patient Elderly Woman 400
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The U.S. Food and Drug Administration (FDA) has issued a new draft guidance addressing cybersecurity in medical devices.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
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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
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