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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. Then, FFDM and DBT images were simulated using a physics-based Monte Carlo x-ray transport code. a clinician model). Read the full paper here.

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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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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.

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Large language models underperform in breast imaging

AuntMinnie

Large language models such as ChatGPT and Google Gemini fall short in breast imaging, a study published April 30 in Radiology found. Simply put, we cannot use large language models as a medical device,” Cozzi told AuntMinnie.com. Simply put, we cannot use large language models as a medical device,” Cozzi told AuntMinnie.com.

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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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Philips Spotlights Scalable and Interoperable Clinical and Operational Solutions at #HIMSS24

Imaging Technology

milla1cf Fri, 03/15/2024 - 16:41 March 15, 2024 — Visitors to the Philips Booth at HIMSS in Orlando, Fla, experienced smart, scalable and sustainable clinical solutions designed to help accelerate speed to diagnosis and treatment while improving operational efficiencies, patient outcomes, health equity, and staff experience.

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Bot Image highlights performance of ProstatID in study

AuntMinnie

AI medical device company Bot Image is highlighting the performance of its ProstatID in a study evaluating its ability to detect, diagnose, and screen for prostate cancer. The device, which has clearance by the U.S. Compared with the device, they achieved an AUC of 0.742.