This year may go down as the point that regulators started to try to get a handle on the use of AI and ML in medical devices. Over the past 10 months, FDA has issued an AI/ML action plan for regulating the technology in medical devices, the European Commission has released contentious plans for the entire AI field and the U.K. has proposed an overhaul of how it regulates AI as a medical device. Now, the U.S. and U.K. have begun working together on a global initiative. Working with their peers at Health Canada, officials at FDA and the U.K.'s MHRA have laid out the following guiding principles: Collectively, the principles cover concerns about the possible biases of algorithms, their applicability to clinical practice and the potential for them to evolve as they are used in the real world. FDA and its collaborators have expanded on each of the principles, explaining, for example, that developers need to have "appropriate controls in place to manage risks of overfitting, unintended bias or degradation of the model" when their systems are "periodically or continually trained after deployment."

The U.S. Food and Drug Administration (FDA), Health Canada, and the UK's Medicines and Healthcare products Regulatory Agency (MHRA) have jointly identified ten guiding principles that can inform the development of Good Machine Learning Practice (GMLP). These guiding principles are intended to help promote safe, effective and high-quality medical devices that use artificial intelligence and machine learning (AI/ML). There is a great deal of interest with these technologies in the medical field, especially with the design and operation of medical devices. This is to the extent that regulatory guidance is required and the opportunity has arisen for a transatlantic protocol to be fashioned between three national regulatory agencies. Artificial intelligence and machine learning technologies have the potential to transform healthcare.

Zeit Medical, which makes an early warning system for strokes during sleep, has raised $2M in a seed round just after leaving Y Combinator's Summer 2021 cohort. The company's work suggests the brain-monitoring headband could save lives by alerting people to possible strokes hours before they might otherwise be noticed, and the new funding will help propel them towards commercial availability. The company's device is a soft headband with a lightweight electroencephalogram (EEG) in it. It works with a smartphone app to analyze brain activity and, using a machine learning model trained by human experts, watch for signs of an impending stroke. I wrote up Zeit's system in detail in August, and little has changed since then, though co-founder and CEO (and now Ferolyn fellow) Orestis Vardoulis noted that a usage study found that people wore the headband on 90 percent of nights, including people using CPAP machines, and there were few complaints about fit or comfort.

The FDA has approved an artificial intelligence-based test for early detection of dementia that can be carried out on an iPad in five minutes. The CognICA Integrated Cognitive Assessment (ICA) test developed by London, UK-based company Cognetivity Neurosciences has been approved by the FDA as an alternative to traditional pen-and-paper tests with some key advantages, according to its developer. Those include high sensitivity to detect early-stage cognitive impairment, which could allow early intervention with treatment or lifestyle changes that might help to slow down the progression of dementia. The digital format also helps to avoid cultural or educational bias in testing, and helps to avoid scenarios where people tested on multiple occasions learn how to score better, masking increases in impairment, said Cognetivity. It can also be carried out unsupervised, saving time and money for health systems and making it particularly suitable for assessments when access to care may be restricted, or to allow ongoing monitoring of patients without clinic visits.

On October 14, 2021, the U.S. Food and Drug Administration ("FDA" or the "Agency") held a virtual workshop entitled, Transparency of Artificial Intelligence ("AI")/Machine Learning ("ML")-enabled Medical Devices. The workshop builds upon previous Agency efforts in the AI/ML space. Back in 2019, FDA issued a discussion paper and request for feedback called, Proposed Regulatory Framework for Modifications to AI/ML-Based Software as a Medical Device ("SaMD"). To support continued framework development and to increase collaboration and innovation between key stakeholders and specialists, FDA created the Digital Health Center of Excellence in 2020. And, in January 2021, FDA published an AI/ML Action Plan, based, in part, on stakeholder feedback to the 2019 discussion paper.

The symptoms and side effects of Covid-19 are scattered across a diagnostic spectrum. Some patients are asymptomatic or experience a mild immune response, while others report significant long-term illnesses, lasting complications, or suffer fatal outcomes. Three researchers from the Georgia Institute of Technology and one from Emory University are trying to help clinicians sort through these factors and spectrum of patient outcomes by equipping healthcare professionals with a new "decision prioritization tool." The team's new artificial intelligence-based tool helps clinicians understand and better predict which adverse effects their Covid-19 patients could experience, based on comorbidities and current side effects -; and, in turn, also helps suggest specific Food and Drug Administration-approved (FDA) drugs that could help treat the disease and improve patient health outcomes. The researcher's latest findings are the focus of a new study published October 21 in Scientific Reports. The team's new methodology, or tool, is called MOATAI-VIR (Mode Of Action proteins & Targeted therapeutic discovery driven by Artificial Intelligence for VIRuses.

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The US Food and Drug Administration has given marketing clearance to CognICA, an artificial intelligence–powered integrated cognitive assessment for the early detection of dementia. Developed by Cognetivity Neurosciences Ltd, CognICA is a 5-minute, computerized cognitive assessment that is completed using an iPad. The test offers several advantages over traditional pen-and-paper-based cognitive tests, the company said in a news release. "These include its high sensitivity to early-stage cognitive impairment, avoidance of cultural or educational bias and absence of learning effect upon repeat testing," the company notes. Because the test runs on a computer, it can support remote, self-administered testing at scale and is geared toward seamless integration with existing electronic health record systems, they add.

The symptoms and side effects of Covid-19 are scattered across a diagnostic spectrum. Some patients are asymptomatic or experience a mild immune response, while others report significant long-term illnesses, lasting complications, or suffer fatal outcomes. Three researchers from the Georgia Institute of Technology and one from Emory University are trying to help clinicians sort through these factors and spectrum of patient outcomes by equipping healthcare professionals with a new "decision prioritization tool." The team's new artificial intelligence-based tool helps clinicians understand and better predict which adverse effects their Covid-19 patients could experience, based on comorbidities and current side effects -- and, in turn, also helps suggest specific Food and Drug Administration-approved (FDA) drugs that could help treat the disease and improve patient health outcomes. The researcher's latest findings are the focus of a new study published October 21 in Scientific Reports.

A massive disruption now appears imminent in one of the world's largest – and most important – industries. In much the same way that Amazon disrupted the retail business – and how PayPal disrupted the payments industry – one under-the-radar health technology company now seeks to transform the $11.85 trillion global health industry. By moving healthcare away from brick and mortar, traditional medicine into an AI-driven tool that offers unprecedented speed, efficiency, and accuracy... Investors still have a brief window of opportunity to get in on this transformational investment opportunity while it still flies beneath Wall Street's radar. But as you'll soon discover, this company's technology is so powerful that it could become a valuable addition to hundreds of millions of households worldwide. Whether most patients, providers, or large healthcare companies realize it or not, the healthcare industry is already in the early stages of significant change. That's because patients now desire access to more information – and better information – in the blink of an eye. In a recent survey of U.S. health consumers, 71% reported facing major frustrations through their experience with healthcare providers. Concerns ranged from difficulties scheduling appointments to impersonal visits.