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Latest AI and machine learning research in fda general for healthcare professionals.

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Can AI generate diagnostic reports for radiologist approval on CXR images? A multi-reader and multi-case observer performance study.

BACKGROUND: Accurately detecting a variety of lung abnormalities from heterogenous chest X-ray (CXR) images and writing radiology reports is often difficult and time-consuming.

Jan 1 2024 39422982

Pivotal trial of a deep-learning-based retinal biomarker (Reti-CVD) in the prediction of cardiovascular disease: data from CMERC-HI.

OBJECTIVE: The potential of using retinal images as a biomarker of cardiovascular disease (CVD) risk has gained significant attention, but regulatory approval of such artificial intelligence (AI) algorithms is lacking. In this regulated pivotal trial, we validated the efficacy of Reti-CVD, an AI-Software as a Medical Device (AI-SaMD), that utilizes retinal images to stratify CVD risk.

Dec 22 2023 37847669
Multimodal imaging and deep learning in geographic atrophy secondary to age-related macular degeneration.

Geographic atrophy (GA) secondary to age-related macular degeneration is among the most common causes of irreversible vision loss in industrialized co...

Dec 1 2023 37933610
THItoGene: a deep learning method for predicting spatial transcriptomics from histological images.

Spatial transcriptomics unveils the complex dynamics of cell regulation and transcriptomes, but it is typically cost-prohibitive. Predicting spatial g...

Nov 22 2023 38145948
[Social Allostasis Regulation by Robots].

Social allostasis, the process by which social interactions dynamically regulate psychophysiological states (e.g., emotions), is attracting attention....

Nov 1 2023 37936427
Efficacy of Pulse Methylprednisolone in Treatment of Acute Respiratory Distress Syndrome due to Malaria: A Randomized Controlled Clinical Trial.

: To study the efficacy of pulse methylprednisolone (MPS) therapy in patients with malaria-associated acute respiratory distress syndrome (ARDS). : Th...

Nov 1 2023 38720494
A multi-scale expression and regulation knowledge base for Escherichia coli.

Transcriptomic data is accumulating rapidly; thus, scalable methods for extracting knowledge from this data are critical. Here, we assembled a top-dow...

Oct 27 2023 37713610
Artificial Intelligence, Computational Simulations, and Extended Reality in Cardiovascular Interventions.

Artificial intelligence, computational simulations, and extended reality, among other 21st century computational technologies, are changing the health...

Oct 23 2023 37879802
FDA-cleared artificial intelligence and machine learning-based medical devices and their 510(k) predicate networks.

The US Food and Drug Administration is clearing an increasing number of artificial intelligence and machine learning (AI/ML)-based medical devices thr...

Sep 1 2023 37625896
A convolutional neural network-based decision support system for neonatal quiet sleep detection.

Sleep plays an important role in neonatal brain and physical development, making its detection and characterization important for assessing early-stag...

Aug 29 2023 37920045
Predicting functional consequences of SNPs on mRNA translation via machine learning.

The functional impact of single nucleotide polymorphisms (SNPs) on translation has yet to be considered when prioritizing disease-causing SNPs from ge...

Aug 25 2023 37427781
[The Concept of a Healthcare AI Platform].

To reduce the burden on medical professionals and achieve advanced medical care in the rapidly evolving and specializing medical field, the widespread...

Jun 1 2023 37317596
Artificial Intelligence in Breast Imaging: Challenges of Integration Into Clinical Practice.

Artificial intelligence (AI) in breast imaging is a rapidly developing field with promising results. Despite the large number of recent publications i...

May 22 2023 38416888
[Legal regulation of clinical application of artificial intelligence].

With the wide application of artificial intelligence (AI) technology in clinical practice, more and more legal problems need to be solved. At present,...

May 16 2023 37020176
[Short-Term and Long-Term Results of Robot-Assisted Rectal Resections Performed in Our Department].

BACKGROUND: We introduced the da Vinci robotic surgical system in 2006 for the first time in Japan, and have been performing robot-assisted rectal can...

Apr 1 2023 37066481
A deep learning-based recognition for dangerous objects imaged in X-ray security inspection device.

Several limitations in algorithms and datasets in the field of X-ray security inspection result in the low accuracy of X-ray image inspection. In the ...

Jan 1 2023 36278390
A novel method for conformity assessment testing of electrocardiographs for post-market surveillance purposes.

BACKGROUND: Monitoring cardiac parameters is the fundamental aspect of every diagnostic process and is facilitated by electrocardiography (ECG) device...

Jan 1 2023 36502354
A novel method for conformity assessment testing of defibrillators for post-market surveillance purposes.

BACKGROUND: Defibrillators are medical devices (MDs) used in the most critical situations, hence their performance must be ensured at all times. This ...

Jan 1 2023 36530104
A novel method for conformity assessment testing of therapeutic ultrasounds for post-market surveillance purposes.

BACKGROUND: Therapeutic ultrasounds are medical devices used for treatment of conditions such muscle spasms, joint contractures or general muscle pain...

Jan 1 2023 36530106
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