FDA General

Robotic Applications for Benign Gynecologic Procedures.

INTRODUCTION: Robotic systems provide a platform for surgeons to expand their capabilities, allowing them to perform complex procedures safely and efficiently. Within the field of benign gynecology, this has become an increasingly popular option since receiving Food and Drug Administration (FDA) approval in 2005. However, the appropriate indications for robotic versus laparoscopic surgery continue...

Conflicting information from the Food and Drug Administration: Missed opportunity to lead standards for safe and effective medical artificial intelligence solutions.

The Food & Drug Administration (FDA) is considering the permanent exemption of premarket notification requirements for several Class I and II medical device products, including several artificial Intelligence (AI)-driven devices. The exemption is based on the need to rapidly more quickly disseminate devices to the public, estimated cost-savings, a lack of documented adverse events reported to the ...

Requirements for implementation of artificial intelligence in the practice of gastrointestinal pathology.

Tremendous advances in artificial intelligence (AI) in medical image analysis have been achieved in recent years. The integration of AI is expected to...

[Robot-assisted nephroureterectomy requiring no robot redocking or patient repositioning: experience from a single center with 62 cases].

To examine a new technique of robot-assisted nephroureterectomy without robot reldocking or patient repositioning. Patients diagnosed as upper tract...

[Construction of Escherichia coli cell factories].

As an important model industrial microorganism, Escherichia coli has been widely used in pharmaceutical, chemical industry and agriculture. In the pas...

Applying deep learning to defect detection in printed circuit boards via a newest model of you-only-look-once.

In this paper, a new model known as YOLO-v5 is initiated to detect defects in PCB. In the past many models and different approaches have been implemen...

MolAICal: a soft tool for 3D drug design of protein targets by artificial intelligence and classical algorithm.

Deep learning is an important branch of artificial intelligence that has been successfully applied into medicine and two-dimensional ligand design. Th...

ARTIFICIAL INTELLIGENCE IN MEDICAL DEVICES: PAST, PRESENT AND FUTURE.

Artificial Intelligence (AI) has been drawing attention in the field of medical devices. However, due to system complexity, the variability of their a...

Modeling multi-species RNA modification through multi-task curriculum learning.

N6-methyladenosine (m6A) is the most pervasive modification in eukaryotic mRNAs. Numerous biological processes are regulated by this critical post-tra...

Machine Learning-Driven Metabolomic Evaluation of Cerebrospinal Fluid: Insights Into Poor Outcomes After Aneurysmal Subarachnoid Hemorrhage.

BACKGROUND: Aneurysmal subarachnoid hemorrhage (aSAH) is associated with a high mortality and poor neurologic outcomes. The biologic underpinnings of ...

How medical AI devices are evaluated: limitations and recommendations from an analysis of FDA approvals.

How machine learning is embedded to support clinician decision making: an analysis of FDA-approved medical devices.

OBJECTIVE: To examine how and to what extent medical devices using machine learning (ML) support clinician decision making.

Key Principles of Clinical Validation, Device Approval, and Insurance Coverage Decisions of Artificial Intelligence.

Artificial intelligence (AI) will likely affect various fields of medicine. This article aims to explain the fundamental principles of clinical valida...

Regulation of AI in Health Care: A Cautionary Tale Considering Horses and Zebras.

The introduction of Artificial Intelligence (AI) into health care has been accompanied by uncertainties and regulatory challenges. The establishment o...

ToxDL: deep learning using primary structure and domain embeddings for assessing protein toxicity.

MOTIVATION: Genetically engineering food crops involves introducing proteins from other species into crop plant species or modifying already existing ...

A Novel Application of Head Tracking Data in the Analysis and Assessment of Operational Cervical Spine Range of Motion for Army Aviators.

INTRODUCTION: Neck pain among rotary-wing aviators has been established as an important issue in the military community, yet no U.S. Army regulation d...

iModulonDB: a knowledgebase of microbial transcriptional regulation derived from machine learning.

Independent component analysis (ICA) of bacterial transcriptomes has emerged as a powerful tool for obtaining co-regulated, independently-modulated ge...

Robotic Single-Port Donor Nephrectomy with the da Vinci SP® Surgical System.

OBJECTIVES: The da Vinci SP® Surgical System received U.S. Food and Drug Administration approval for urological procedures in 2018. Here, we describe ...

Artificial intelligence in colonoscopy - Now on the market. What's next?

Adoption of artificial intelligence (AI) in clinical medicine is revolutionizing daily practice. In the field of colonoscopy, major endoscopy manufact...

Sequence-Based Deep Learning Frameworks on Enhancer-Promoter Interactions Prediction.

Enhancer-promoter interactions (EPIs) in the human genome are of great significance to transcriptional regulation, which tightly controls gene express...