Regulatory: Page 22

Ezra gets FDA clearance for prostate AI software
By AuntMinnie.com staff writers
Cancer screening startup Ezra has received U.S. Food and Drug Administration (FDA) clearance for Ezra Prostate AI, an artificial intelligence (AI)-based software application designed to help radiologists analyze and segment prostate MRI exams.
October 19, 2020
2020 10 20 18 29 1638 2020 10 20 Ezra 3 D Prostate Lesion Ai 20201020184140
Feedback on FDA's proposed AI rules had industry ties
By Erik L. Ridley
Nearly two-thirds of commenters on last year's proposed regulatory framework from the U.S. Food and Drug Administration (FDA) for continuously learning artificial intelligence (AI) algorithms had financial ties to industry, while an additional 29% had unclear ties, according to a study posted online October 14 in BMJ Open.
October 15, 2020
2019 10 21 17 41 6509 Artificial Intelligence Ai Suit 400
Federal provider relief programs are continuously changing
By Rebecca Farrington
The COVID-19 pandemic spawned many programs designed to assist medical practices. The terms and conditions of many of the various relief programs have changed since they were first introduced, and Rebecca Farrington of Healthcare Administrative Partners helps explain recent changes.
October 14, 2020
2020 07 31 22 16 0362 Dollar Money Coronavirus Mask 400
CMS announces new COVID-19 loan repayment terms
By AuntMinnie.com staff writers
The U.S. Centers for Medicare and Medicaid Services (CMS) has announced new terms for repaying COVID-19 Medicare loans.
October 7, 2020
2019 10 30 21 49 9027 Cms Building 400
Get feedback on your 2019 Quality Payment Program status
By Erin Stephens
Participants in the Quality Payment Program can now obtain information about whether their practice will receive a positive, negative, or neutral Medicare fee schedule adjustment. Erin Stephens of Healthcare Administrative Partners explains.
September 30, 2020
2020 09 08 23 56 6553 Business Accounting Calculator 400
FDA updates variance application process
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health has updated the variance application process for Electronic Product Radiation Control.
September 27, 2020
2016 09 02 09 36 05 93 Fda Logo V2 400
Fla. radiology practice pays Medicare settlement
By AuntMinnie.com staff writers
A radiology practice in Florida has agreed to pay a $501,000 settlement to resolve allegations that it improperly billed Medicare and Tricare, the federal healthcare program for veterans.
September 27, 2020
2020 08 14 20 02 8002 Gavel Money 400
Telix files NDA for prostate cancer PET imaging agent
By AuntMinnie.com staff writers
Radiopharmaceutical company Telix Pharmaceuticals has submitted a new drug application (NDA) to the U.S. Food and Drug Administration for TLX591-CDx, its gallium-68-based radiopharmaceutical for PET imaging of prostate cancer.
September 23, 2020
2017 06 15 10 31 55 42 Prostate 400
Will Medicare reimbursement propel radiology AI market?
By Erik L. Ridley
The decision by the U.S. Centers for Medicare and Medicaid Services' earlier this month to provide its first-ever reimbursement of a radiology artificial intelligence (AI) algorithm was a significant milestone for the industry, raising hopes that it could set the groundwork for broader coverage of imaging AI software.
September 22, 2020
2019 12 09 17 23 6730 Artificial Intelligence Ai Suit 400
Medicare delays recoupment of advances
By Rebecca Farrington
One of the fastest sources of emergency funding available to practices at the outset of the COVID-19 pandemic was the Medicare Accelerated and Advanced Payment Program. But Medicare has not yet provided details on recoupment of the funds -- Rebecca Farrington of Healthcare Administrative Partners explains.
September 21, 2020
2020 07 22 22 57 7185 Coronavirus Business Graphic 400
CMS releases new payment model for radiation oncology
By Brian Casey
The U.S. Centers for Medicare and Medicaid Services (CMS) today released its long-awaited Radiation Oncology Model, an alternative method for the agency to pay for radiation therapy procedures in the Medicare and Medicaid systems.
September 17, 2020
2018 11 14 23 24 9873 Radiation Therapy Suite 400
GE gets FDA nod to package Clariscan in polymer bottle
By AuntMinnie.com staff writers
GE Healthcare has received U.S. Food and Drug Administration (FDA) clearance to use its +PlusPak pharmacy bulk package polymer bottle for the company's Clariscan macrocyclic gadolinium-based MRI contrast agent.
September 14, 2020
2020 01 29 18 12 5932 Ge Rsna 2019 400
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