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Positron Corporation Announces Start of Clinical Study of Affinity PET-CT Device

Imaging Technology

milla1cf Fri, 09/08/2023 - 16:25 September 8, 2023 — Positron Corporation , a leading molecular imaging medical device company, is pleased to announce that the Company will begin its clinical study of its Affinity PET-CT imaging device with Ochsner Clinic Foundation in New Orleans, LA. on September 18, 2023.

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FDA analysis affirms use of computational models in imaging trials

AuntMinnie

In silico imaging trials represent a viable source of regulatory evidence for imaging device evaluation, according to an analysis conducted by the U.S. Food and Drug Administration (FDA) and published August 9 in Plos Computational Biology. Read the full paper here.

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Commercial AI devices lack clinical validation, study finds

AuntMinnie

Commercial AI devices that lack adequate clinical validation may pose risks for patient care – and unfortunately, that’s true for almost half of the tools cleared so far by the U.S. Most notably, 226 of 521 (43%) lacked published clinical validation data.

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Hyperfine Announces FDA Clearance of Software Update That Enables Faster Acquisition of Best-in-Class Ultra-Low-Field Brain Images

Imaging Technology

mtaschetta-millane Wed, 07/17/2024 - 10:52 July 17, 2024 — Hyperfine , a groundbreaking medical device company that has redefined brain imaging with the world’s first FDA-cleared portable magnetic resonance brain imaging system—the Swoop system—announced the clearance of the ninth generation of AI-powered Swoop system software.

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InkSpace Imaging receives FDA Clearance for a 24-channel Small Body Array Compatible with Siemens Healthineers 3T Systems

Imaging Technology

milla1cf Fri, 01/26/2024 - 21:11 January 26, 2024 — InkSpace Imaging , a leader in innovative diagnostic medical device technology, is proud to announce it received FDA clearance for its next-generation Small Body Array for the Siemens Healthineers Magnetom Skyra and Vida series 3T MRI scanners.

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Large language models underperform in breast imaging

AuntMinnie

Simply put, we cannot use large language models as a medical device,” Cozzi told AuntMinnie.com. The researchers also assessed the impact of discordant category assignments on clinical management. Frequency of BI-RADS category changes in clinical management of breast imaging findings Finding Human readers Gemini GPT-3.5

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ACR responds to Congressional query on AI reimbursement

AuntMinnie

MD, issued a nine-page letter to Congress recommending how to solve the reimbursement problem for AI in healthcare and ensure clinical AI is of value to patients and health systems. American College of Radiology (ACR) CEO William Thorwarth Jr.,