New Developments in FDA Regulation of AI

CONCLUSION On the whole, FDA seems very enthusiastic about the possibilities for AI to improve healthcare.  That’s gratifying to see. While progress in the development of a new regulatory approach is slow, that’s also not all bad. It would be worse in many ways for FDA to act precipitously.  These are complicated issues, and it will take time to develop an appropriate approach, in part because it will take time for FDA to acquire enough expertise. And most likely, whatever new approach we come up with will require new statutory authority. That said, it is incumbent on all of us to work as quickly as we can to bring these exciting new developments to waiting patients.  The possible improvements to patient care are enormous. References Clinical Decision Support Software Draft Guidance for Industry and FDA Staff, September 2019, https://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-decision-support-software. Section 201(h) of the Food, Drug &Cosmetic Act (21 U.S.C. 321(h)) Agenda for Quarterly Meeting on MDUFA IV (FY 2018-2022) Performance November 15, 2019, page 277 https://www.fda.gov/media/132770/download.  "FDA still trying to fine-tune Pre-Cert as pilot enters 2020," Medtech Dive, March 2020, https://www.medtechdive.com/news/fda-pre-cert-software-device-pilot-enters-another-year/574822/ Proposed Regulatory Framework for Modifications to Artificial I...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Source Type: news

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When Eric Freeland, 34, started coughing at the end of March, he didn’t think much of it. But when his symptoms grew worse, Freeland’s mother began to worry. Freeland is a Native American living with his family in the Navajo Nation in the southwestern U.S., where access to healthcare is limited. He is also diabetic, putting him at greater risk to the coronavirus. When Freeland’s breathing became short and stuttered, his mother drove him to the nearest hospital where within minutes of arriving, he lost consciousness. He awoke three weeks later, hooked up to a ventilator, from a medically induced coma. &l...
Source: TIME: Health - Category: Consumer Health News Authors: Tags: Uncategorized COVID-19 feature Londontime Source Type: news
ABSTRACT The coronavirus disease 2019 (covid-19) pandemic has caused a public health emergency worldwide. Risk, severity and mortality of the disease have been associated with non-communicable chronic diseases, such as diabetes mellitus. Accumulated evidence has caused great concern in countries with high prevalence of this morbidity, such as Brazil. This text shows the picture of diabetes in Brazil, followed by epidemiological data and explanatory hypothesis for the association between diabetes and covid-19. We emphasized how the burden of these two morbidities in a middle-income country has aggravated this pandemic scena...
Source: Revista de Saude Publica - Category: International Medicine & Public Health Source Type: research
onikaki The coronavirus disease, COVID-19, caused by the novel coronavirus SARS-CoV-2, which first emerged in Wuhan, China and was made known to the World in December 2019 turned into a pandemic causing more than 126,124 deaths worldwide up to April 16th, 2020. It has 79.5% sequence identity with SARS-CoV-1 and the same strategy for host cell invasion through the ACE-2 surface protein. Since the development of novel drugs is a long-lasting process, researchers look for effective substances among drugs already approved or developed for other purposes. The 3D structure of the SARS-CoV-2 main protease was compared with th...
Source: Molecules - Category: Chemistry Authors: Tags: Article Source Type: research
This article discusses the potential mechanisms by which SARS-CoV-2 modulates the RAS and energy metabolism in individuals with obesity and diabetes mellitus. The article aims to highlight the appropriate strategies for combating the COVID-19 pandemic in the clinical setting and emphasize on the areas that require further investigation in relation to COVID-19 infections in patients with obesity and diabetes mellitus, from the viewpoint of endocrinology and metabolism. PMID: 32469255 [PubMed - as supplied by publisher]
Source: American Journal of Physiology. Endocrinology and Metabolism - Category: Physiology Authors: Tags: Am J Physiol Endocrinol Metab Source Type: research
The mainstream (&the sidestream) medical media have already named one culprit ie hypertension (HT) as a significant comorbid entity in the current Corona pandemic. But, If we ask one direct question, how Corona and HT are linked ? , the answer is not forthcoming fluently. . Some of the thought process about the Issue. 1. Does Coronavirus relish high blood pressure on its journey to attack lungs ? Funny question you may think. The virus primarily lives and tracts through the respiratory tract to reach lungs. Viral load in bloodstream is nil or  miniscule till late stages. BP is nothing to do with what is ...
Source: Dr.S.Venkatesan MD - Category: Cardiology Authors: Tags: Uncategorized what is the link between hypertension and corona outcome Source Type: blogs
AbstractPurpose of ReviewThe novel Coronavirus (2019-nCoV, COVID-19) is historically one of the most severe acute respiratory syndromes and pandemics to affect the globe in the twenty-first century. Originating in Wuhan, the virus rapidly spread and impacted subsets of populations with initial unclear risk factors contributing to worsening morbidity and mortality. Patients with diagnosis of cancer and undergoing treatment further represent a population at risk for worsening cardiopulmonary outcomes. This review explores specific risk factors, diagnoses, and treatment options that impact cardio-oncologic patients with COVID...
Source: Current Oncology Reports - Category: Cancer & Oncology Source Type: research
Only about half of Americans say they would get a COVID-19 vaccine if the scientists working furiously to create one succeed, according to a new poll from The Associated Press-NORC Center for Public Affairs Research. That’s surprisingly low considering the effort going into the global race for a vaccine against the coronavirus that has sparked a pandemic since first emerging from China late last year. But more people might eventually roll up their sleeves: The poll, released Wednesday, found 31% simply weren’t sure if they’d get vaccinated. Another 1 in 5 said they’d refuse. Health experts already w...
Source: TIME: Health - Category: Consumer Health News Authors: Tags: Uncategorized COVID-19 News Desk wire Source Type: news
(AP) – Only about half of Americans say they would get a COVID-19 vaccine if the scientists working furiously to create one succeed, according to a new poll from The Associated Press-NORC Center for Public Affairs Research. That’s surprisingly low considering the effort going into the global race for a vaccine against the coronavirus that has sparked a pandemic since first emerging from China late last year. But more people might eventually roll up their sleeves: The poll, released Wednesday, found 31% simply weren’t sure if they’d get vaccinated. Another 1 in 5 said they’d refuse. Moderna the...
Source: WBZ-TV - Breaking News, Weather and Sports for Boston, Worcester and New Hampshire - Category: Consumer Health News Authors: Tags: Boston News Covid-19 Boston, MA Health Healthcare Status Syndicated CBSN Boston Syndicated Local Coronavirus Source Type: news
(Image source: WHO) There are two key differences between the novel coronavirus that causes COVID-19 and 5G technology. One has spread across the globe, the other has barely rolled out in most countries and in some cases not at all. That hasn’t stopped conspiracy theorists from conflating the two however. Thanks to a combination of scam artists, the reach of social media, ignorant celebrities and influencers, and general public frustration and confusion, a strange theory has emerged in the months since the global COVID-19 pandemic started. Allegedly, 5G is the culprit behind the pandemic. Citing a lot of ...
Source: MDDI - Category: Medical Devices Tags: Design News Source Type: news
AbstractCoronavirus diseases 2019 (COVID-19) has become a worldwide pandemic affecting people at high risk and particularly at advanced age, cardiovascular and pulmonary disease. As cardiovascular patients are at high risk but also have dyspnea and fatigue as leading symptoms, prevention, diagnostics and treatment in these patients are important to provide adequate care for those with or without COVID-19 but most importantly when comorbid cardiovascular conditions are present. Severe COVID-19 with acute respiratory distress (ARDS) is challenging as patients with elevated myocardial markers such as troponin are at enhanced ...
Source: Clinical Research in Cardiology - Category: Cardiology Source Type: research
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