The state of artificial intelligence-based FDA-approved medical devices and algorithms: An online database (Preprint)

2020 ◽  
Author(s):  
Bertalan Mesko ◽  
Stan Benjamens ◽  
Pranavsingh Dhunnoo
Keyword(s):  
Artificial Intelligence ◽  
Medical Devices ◽  
De Novo ◽  
Online Database ◽  
Medical Technologies ◽  
Open Access Database ◽  
Regulatory Bodies ◽  
Premarket Approval ◽  
Insight Into ◽  
The U.S

BACKGROUND At the beginning of the artificial intelligence (A.I.) era, the expectations are high, and experts foresee that A.I. shows potential for diagnosing, managing and treating a wide variety of medical conditions. However, the obstacles for implementation of A.I. in daily clinical practice are numerous, especially regarding the regulation of these technologies. OBJECTIVE Therefore, we provide an insight into the currently available A.I.-based medical devices and algorithms that have been approved by the U.S. Food & Drugs Administration (FDA). We aimed to raise awareness about the importance of regulatory bodies, clearly stating whether a medical device is A.I.-based or not. METHODS Cross-checking and validating all approvals, we identified 64 A.I.-based, FDA approved medical devices and algorithms. Out of those, only 29 (45%) mentioned any A.I.-related expressions in the official FDA announcement. RESULTS The majority (85.9%) was approved by the FDA with a 510(k) clearance, while 8 (12.5%) received de novo pathway clearance and one (1.6%) premarket approval (PMA) clearance. Most of these technologies, notably 30 (46.9%), 16 (25.0%) and 10 (15.6%) were developed for the fields of Radiology, Cardiology and Internal Medicine / General Practice respectively. CONCLUSIONS We launched the first comprehensive and open access database of strictly A.I.-based medical technologies that have been approved by the FDA. The database will be constantly updated. 

scholarly journals The state of artificial intelligence-based FDA-approved medical devices and algorithms: an online database

2020 ◽  
Vol 3 (1) ◽  
Author(s):  
Stan Benjamens ◽  
Pranavsingh Dhunnoo ◽  
Bertalan Meskó
Keyword(s):  
Artificial Intelligence ◽  
Medical Devices ◽  
De Novo ◽  
Online Database ◽  
Medical Technologies ◽  
The Us ◽  
Open Access Database ◽  
Regulatory Bodies ◽  
Premarket Approval ◽  
Insight Into

Abstract At the beginning of the artificial intelligence (AI)/machine learning (ML) era, the expectations are high, and experts foresee that AI/ML shows potential for diagnosing, managing and treating a wide variety of medical conditions. However, the obstacles for implementation of AI/ML in daily clinical practice are numerous, especially regarding the regulation of these technologies. Therefore, we provide an insight into the currently available AI/ML-based medical devices and algorithms that have been approved by the US Food & Drugs Administration (FDA). We aimed to raise awareness of the importance of regulatory bodies, clearly stating whether a medical device is AI/ML based or not. Cross-checking and validating all approvals, we identified 64 AI/ML based, FDA approved medical devices and algorithms. Out of those, only 29 (45%) mentioned any AI/ML-related expressions in the official FDA announcement. The majority (85.9%) was approved by the FDA with a 510(k) clearance, while 8 (12.5%) received de novo pathway clearance and one (1.6%) premarket approval (PMA) clearance. Most of these technologies, notably 30 (46.9%), 16 (25.0%), and 10 (15.6%) were developed for the fields of Radiology, Cardiology and Internal Medicine/General Practice respectively. We have launched the first comprehensive and open access database of strictly AI/ML-based medical technologies that have been approved by the FDA. The database will be constantly updated.

scholarly journals U.S. AI Workforce: Labor Market Dynamics

2021 ◽  
Author(s):  
Diana Gehlhaus ◽  
Ilya Rahkovsky
Keyword(s):  
Artificial Intelligence ◽  
Labor Market ◽  
The State ◽  
Potential Effectiveness ◽  
Good Data ◽  
Information Gap ◽  
Labor Market Dynamics ◽  
Ongoing Concern ◽  
Insight Into ◽  
The U.S

A lack of good data on the U.S. artificial intelligence workforce limits the potential effectiveness of policies meant to increase and cultivate this cadre of talent. In this issue brief, the authors bridge that information gap with new analysis on the state of the U.S. AI workforce, along with insight into the ongoing concern over AI talent shortages. Their findings suggest some segments of the AI workforce are more likely than others to be experiencing a supply-demand gap.

scholarly journals New Medical Device and Therapeutic Approvals in Otolaryngology: State of the Art Review of 2019

OTO Open ◽  
2020 ◽  
Vol 4 (2) ◽  
pp. 2473974X2093250
Author(s):  
Anais Rameau ◽  
Robert Stephen Hong ◽  
Hamid Djalilian ◽  
Isaac David Erbele ◽  
Katie M. Phillips ◽  
...  
Keyword(s):  
Head And Neck ◽  
Plastic Surgery ◽  
Medical Devices ◽  
De Novo ◽  
Neck Surgery ◽  
Head And Neck Surgery ◽  
Standards Of Care ◽  
Significant Heterogeneity ◽  
Premarket Approval ◽  
New Devices

Objective To review new devices and drugs relevant to otolaryngology–head and neck surgery that were approved by the US Food and Drug Administration (FDA) in 2019. Data Sources Approval notifications for 2019 were extracted from the ENT (ear, nose, and throat) and general and plastic surgery sections of the FDA’s medical devices and therapeutics listings. Review Methods New therapeutics and medical devices identified from the query were analyzed by members of the American Academy of Otolaryngology–Head and Neck Surgery’s Medical Devices and Drugs Committee. Technologies were assessed by 2 independent reviewers to ascertain relevance to otolaryngology, prioritized, and classified to subspecialty field with critical review based on extant scientific literature. Conclusions Query of the FDA drug and device database returned 105 ENT devices (50 cleared, 55 with premarket approval, and 0 de novo), 543 general and plastic surgery devices (372 cleared, 170 with premarket approval, and 1 de novo), and 46 new otolaryngology-relevant drug approvals that occurred in 2019. Advances spanned all subspecialty areas with otology predominating, primarily due to hearing-related technologies. While scientific evidence was available for all new devices, there was significant heterogeneity in rigor of supporting scientific data. Implications for Practice Technological and pharmaceutical innovation is an important catalyst for advances in the surgical specialties. Familiarity with new devices and therapeutics in otolaryngology–head and neck surgery ensures that clinicians keep abreast of developments with potential to improve prevailing standards of care.

Premarket Review of Medical Devices in the United States

2000 ◽  
Vol 7 (3) ◽  
pp. 293-326
Author(s):  
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Regulatory System ◽  
The United States ◽  
The Public ◽  
The World ◽  
Contemporary Perspective ◽  
Premarket Approval ◽  
The U.S ◽  
Medical Device Regulation

AbstractIt has been sixty years since the Congress first authorized FDA to regulate medical devices. During this period, countless studies, reports, and investigations have been targeted at medical devices. The law has been significantly modified several times, and the regulations revised on numerous occasions. As for any other scheme of administration or management, revisions are necessary as demand arises for legislative attention to societal risks, the economy fluctuates, and when businesses expand and globalize. Studying the U.S. system of medical device regulation merely from a contemporary perspective fails to take into account the significance of decades of effort in maintaining the quality and integrity of the system in an ever-changing field of medical device regulation.The three-pronged medical device regulatory system that entails inspection of manufacturing facilities, premarket approval, and postmarket recall and reporting enables the public to benefit from medical devices without the fear of unreasonable risk with their use (Appendix 1). President Clinton proudly pronounced the following in a 1995 speech:Today, Americans don't have to worry about safety or effectiveness when they buy [drugs and medical devices] - from cough syrups to the latest antibiotics or pacemakers. The Food and Drug Administration has made American drugs and medical devices the envy of the world and in demand all over the world. And we are going to stick with the standards we have - the highest in the world.…^218

scholarly journals The Dfam community resource of transposable element families, sequence models, and genome annotations

Mobile DNA ◽  
2021 ◽  
Vol 12 (1) ◽  
Author(s):  
Jessica Storer ◽  
Robert Hubley ◽  
Jeb Rosen ◽  
Travis J. Wheeler ◽  
Arian F. Smit
Keyword(s):  
Transposable Element ◽  
De Novo ◽  
Consensus Sequence ◽  
Model Organisms ◽  
Community Resource ◽  
Open Access Database ◽  
Genome Annotations ◽  
Protein Alignments ◽  
Insight Into

AbstractDfam is an open access database of repetitive DNA families, sequence models, and genome annotations. The 3.0–3.3 releases of Dfam (https://dfam.org) represent an evolution from a proof-of-principle collection of transposable element families in model organisms into a community resource for a broad range of species, and for both curated and uncurated datasets. In addition, releases since Dfam 3.0 provide auxiliary consensus sequence models, transposable element protein alignments, and a formalized classification system to support the growing diversity of organisms represented in the resource. The latest release includes 266,740 new de novo generated transposable element families from 336 species contributed by the EBI. This expansion demonstrates the utility of many of Dfam’s new features and provides insight into the long term challenges ahead for improving de novo generated transposable element datasets.

scholarly journals cheML.io: an online database of ML-generated molecules

RSC Advances ◽  
2020 ◽  
Vol 10 (73) ◽  
pp. 45189-45198
Author(s):  
Rustam Zhumagambetov ◽  
Daniyar Kazbek ◽  
Mansur Shakipov ◽  
Daulet Maksut ◽  
Vsevolod A. Peshkov ◽  
...  
Keyword(s):  
Open Access ◽  
De Novo ◽  
Online Database ◽  
Open Access Database ◽  
Access Database

Several recent ML algorithms for de novo molecule generation have been utilized to create an open-access database of virtual molecules.

AI Narratives

2020 ◽  
Keyword(s):  
Artificial Intelligence ◽  
New Technologies ◽  
Ancient Greece ◽  
Historical Overview ◽  
Intelligent Machines ◽  
Narrative History ◽  
History Of ◽  
Imaginative Thinking ◽  
The Relationship ◽  
Insight Into

This book is the first to examine the history of imaginative thinking about intelligent machines. As real artificial intelligence (AI) begins to touch on all aspects of our lives, this long narrative history shapes how the technology is developed, deployed, and regulated. It is therefore a crucial social and ethical issue. Part I of this book provides a historical overview from ancient Greece to the start of modernity. These chapters explore the revealing prehistory of key concerns of contemporary AI discourse, from the nature of mind and creativity to issues of power and rights, from the tension between fascination and ambivalence to investigations into artificial voices and technophobia. Part II focuses on the twentieth and twenty-first centuries in which a greater density of narratives emerged alongside rapid developments in AI technology. These chapters reveal not only how AI narratives have consistently been entangled with the emergence of real robotics and AI, but also how they offer a rich source of insight into how we might live with these revolutionary machines. Through their close textual engagements, these chapters explore the relationship between imaginative narratives and contemporary debates about AI’s social, ethical, and philosophical consequences, including questions of dehumanization, automation, anthropomorphization, cybernetics, cyberpunk, immortality, slavery, and governance. The contributions, from leading humanities and social science scholars, show that narratives about AI offer a crucial epistemic site for exploring contemporary debates about these powerful new technologies.

Ethics of Artificial Intelligence in Transport

2020 ◽  
pp. 667-683
Author(s):  
Bryant Walker Smith
Keyword(s):  
Artificial Intelligence ◽  
Ethical Issues ◽  
Ethical Question ◽  
Power Dynamics ◽  
Automated Vehicles ◽  
Automated Driving ◽  
The U.S ◽  
Policy Solutions

This chapter highlights key ethical issues in the use of artificial intelligence in transport by using automated driving as an example. These issues include the tension between technological solutions and policy solutions; the consequences of safety expectations; the complex choice between human authority and computer authority; and power dynamics among individuals, governments, and companies. In 2017 and 2018, the U.S. Congress considered automated driving legislation that was generally supported by many of the larger automated-driving developers. However, this automated-driving legislation failed to pass because of a lack of trust in technologies and institutions. Trustworthiness is much more of an ethical question. Automated vehicles will not be driven by individuals or even by computers; they will be driven by companies acting through their human and machine agents. An essential issue for this field—and for artificial intelligence generally—is how the companies that develop and deploy these technologies should earn people’s trust.

Regulating Medical Devices in the United States

2020 ◽  
Author(s):  
Patricia J. Zettler ◽  
Erika Lietzan
Keyword(s):  
United States ◽  
Medical Device ◽  
Medical Devices ◽  
Complete Information ◽  
The United States ◽  
Risk Level ◽  
Management Tools ◽  
Medical Technologies ◽  
The Us ◽  
Medical Device Regulation

This chapter assesses the regulation of medical devices in the United States. The goal of the US regulatory framework governing medical devices is the same as the goal of the framework governing medicines. US law aims to ensure that medical devices are safe and effective for their intended uses; that they become available for patients promptly; and that manufacturers provide truthful, non-misleading, and complete information about the products. US medical device law is different from US medicines law in many ways, however, perhaps most notably because most marketed devices do not require pre-market approval. The chapter explores how the US Food and Drug Administration (FDA) seeks to accomplish its mission with respect to medical devicecough its implementation of its medical device authorities. It starts by explaining what constitutes a medical device and how the FDA classifies medical devices by risk level. The chapter then discusses how medical devices reach the market, the FDA's risk management tools, and the rules and incentives for innovation and competition. It concludes by exploring case studies of innovative medical technologies that challenge the traditional US regulatory scheme to consider the future of medical device regulation.

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