Utility of a deep-learning algorithm to guide novices to acquire echocardiograms for limited diagnostic use

A Narang, R Bae, H Hong, Y Thomas, S Surette… - JAMA …, 2021 - jamanetwork.com
Importance Artificial intelligence (AI) has been applied to analysis of medical imaging in
recent years, but AI to guide the acquisition of ultrasonography images is a novel area of …

Multireader diagnostic accuracy imaging studies: fundamentals of design and analysis

NA Obuchowski, J Bullen - Radiology, 2022 - pubs.rsna.org
The design and analysis of multireader multicase (MRMC) studies are quite challenging.
These studies differ from most medical studies because they need a reference standard and …

Clinical validation of artificial intelligence–augmented pathology diagnosis demonstrates significant gains in diagnostic accuracy in prostate cancer detection

P Raciti, J Sue, JA Retamero… - … of Pathology & …, 2023 - meridian.allenpress.com
Context.—Prostate cancer diagnosis rests on accurate assessment of tissue by a
pathologist. The application of artificial intelligence (AI) to digitized whole slide images …

Regulatory considerations for medical imaging AI/ML devices in the United States: concepts and challenges

N Petrick, W Chen, JG Delfino… - Journal of Medical …, 2023 - spiedigitallibrary.org
Purpose To introduce developers to medical device regulatory processes and data
considerations in artificial intelligence and machine learning (AI/ML) device submissions …

Advancing regulatory science with computational modeling for medical devices at the FDA's Office of Science and Engineering Laboratories

TM Morrison, P Pathmanathan, M Adwan… - Frontiers in …, 2018 - frontiersin.org
Protecting and promoting public health is the mission of the US Food and Drug
Administration (FDA). FDA's Center for Devices and Radiological Health (CDRH), which …

Diagnostic Accuracy of Multiparametric MRI versus 68Ga-PSMA-11 PET/MRI for Extracapsular Extension and Seminal Vesicle Invasion in …

UJ Muehlematter, IA Burger, AS Becker, K Schawkat… - Radiology, 2019 - pubs.rsna.org
Background Recent studies have reported the additive value of combined gallium 68 (68Ga)-
labeled Glu-urea-Lys (Ahx)-HBED-CC ligand targeting the prostate-specific membrane …

[图书][B] Statistical evaluation of diagnostic performance: topics in ROC analysis

KH Zou, A Liu, AI Bandos, L Ohno-Machado… - 2011 - books.google.com
Statistical evaluation of diagnostic performance in general and Receiver Operating
Characteristic (ROC) analysis in particular are important for assessing the performance of …

Evaluation of computer‐aided detection and diagnosis systemsa)

N Petrick, B Sahiner, SG Armato III, A Bert… - Medical …, 2013 - Wiley Online Library
Computer‐aided detection and diagnosis (CAD) systems are increasingly being used as an
aid by clinicians for detection and interpretation of diseases. Computer‐aided detection …

Comparison of mammography and mammography with supplemental whole-breast US tomography for cancer detection in patients with dense breasts

MW Yamashita, LH Larsen, J Perez, AV Edwards… - Radiology, 2024 - pubs.rsna.org
Background Women with dense breasts benefit from supplemental cancer screening with
US, but US has low specificity. Purpose To evaluate the performance of breast US …

In silico imaging clinical trials: cheaper, faster, better, safer, and more scalable

A Badano - Trials, 2021 - Springer
Imaging clinical trials can be burdensome and often delay patient access to novel, high-
quality medical devices. Tools for in silico imaging trials have significantly improved in …