Regulatory: Page 4

Intelligent Ultrasound nerve block device gets FDA clearance
By AuntMinnie.com staff writers
Intelligent Ultrasound Group said its ScanNav Anatomy Peripheral Nerve Block device has been granted de novo clearance for clinical use by the U.S. Food and Drug Administration (FDA).
October 19, 2022
2020 08 12 16 08 9001 Ultrasound Sound Waves 400
Neosoma nets FDA clearance for brain MRI AI software
By AuntMinnie.com staff writers
Artificial intelligence (AI) software developer Neosoma has received U.S. Food and Drug Administration (FDA) 510(k) clearance for Neosoma HGG, an AI application for assessing high-grade glioma (HGG) on brain MRI exams.
October 6, 2022
2018 08 10 22 42 4903 Artificial Intelligence Brain 400
FDA adds new products to list of cleared AI devices
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) has added 178 new artificial intelligence (AI) and machine learning-enabled medical devices and software applications to a list of products that have been cleared by the agency.
October 4, 2022
2019 02 13 19 24 5396 Fda Logo V2 400
President of Ohio portable x-ray firm gets 15-year prison term
By Brian Casey
The president of a portable x-ray firm in Ohio has been sentenced to 15 years in prison for a scheme in which he defrauded the Medicare and Medicaid system of $2 million for services the company did not provide.
September 29, 2022
2021 08 02 22 58 6925 Legal Scales 400
FDA and VHA launch medical technology collaboration
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) and the Veterans Health Administration (VHA) have committed to working together on efforts to help accelerate American medical device innovation.
September 28, 2022
2019 10 25 00 49 3370 Hands Shaking2 400
FDA finalizes guidance for clinical decision support
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) has finalized its industry guidance for clinical decision-support software.
September 26, 2022
2016 09 02 09 36 05 93 Fda Logo V2 400
What's next for AI regulations in medical imaging?
By AJ Watson
The U.S. Food and Drug Administration continues to consider its approach to regulating artificial intelligence (AI) software. AJ Watson of Intelerad Medical Systems makes the case for flexible and adaptable regulation of the technology.
September 26, 2022
2019 12 09 17 23 6730 Artificial Intelligence Ai Suit 400
What will the MIPS Value Pathways option mean for radiology?
By Erin Stephens
Beginning in 2023, physicians will have the option to report under the Medicare Quality Payment Program using Medicare Incentive-based Payment System (MIPS) Value Pathways in lieu of the traditional reporting methods. Erin Stephens of Healthcare Administrative Partners breaks down what this means to radiology.
September 25, 2022
2020 09 08 23 56 6553 Business Accounting Calculator 400
The No Surprises Act final rule changes dispute resolution process
By Sandy Coffta
The final rule related to the No Surprises Act has made major changes to the independent dispute resolution process for resolving disputes over reimbursement. Sandy Coffta of Healthcare Administrative Partners explains how it works.
September 18, 2022
2019 11 13 00 46 2926 Business Deal Corporate 400
ASTRO applauds legislation on 'real-time' prior authorizations
By AuntMinnie.com staff writers
The American Society for Radiation Oncology (ASTRO) is applauding passage of legislation in the U.S. House of Representatives intended to revamp Medicare Advantage prior authorization practices.
September 14, 2022
2019 09 16 03 57 7061 Astro 2019 400
FDA issues alert on cancers near implant scar tissue
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) has issued a safety alert regarding squamous cell carcinoma and various lymphomas that can appear in scar tissue near breast implants.
September 8, 2022
2016 09 02 09 36 05 93 Fda Logo V2 400
Review of mammograms in Canada finds 9 'discrepancies'
By AuntMinnie.com staff writers
An ongoing review of thousands of mammograms at a Canadian health system has found nine cases in which there might be a "possible discrepancy or differing opinion."
September 6, 2022
2016 09 15 16 37 49 921 Mammogram Calendar 400
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