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FDA Clears World's First AI-Driven Portable 3D Breast Ultrasound Scanner

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This week iSono Health announced FDA clearance of the company's ATUSA System for breast imaging. This is world's first AI-driven portable and automated 3D breast ultrasound scanner. In just 2 minutes, the ATUSA system automatically scans the entire breast volume, independent of operator expertise, and offers 3D visualization of the breast tissue. The ATUSA system is designed from the ground up to seamlessly integrate with advanced machine learning models that will give physicians a comprehensive set of tools for decision making and patient management. This is the first of several intended FDA submissions for the company.


AI, ML, & Cybersecurity: Here's What FDA May Soon Be Asking

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FDA has released a number of documents that could help clarify its expectations for artificial intelligence, machine learning, and cybersecurity. These include Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan, published in January 2021; Good Machine Learning Practice for Medical Device Development: Guiding Principles, published in October 2021; and the just-released draft guidance, Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions. The AI/ML action plan provides a "more tailored regulatory framework for AI/ML," explained Pavlovic. She referred to FDA's 2019 discussion paper, Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) - Discussion Paper and Request for Feedback, which laid out a "total product lifecycle approach to AI/ML regulations with the understanding that AI/ML products can be iterated much more efficiently and quickly than a typical medical device implant product or something that isn't software based." This is "because there is an opportunity to add additional data to training sets on which the products were originally formulated," she said.


The Hazard-Filled Ruling on the Transportation Mask Mandate

The New Yorker

"At first blush," Judge Kathryn Kimball Mizelle wrote in her order, on Monday, throwing out the federal mask mandate for people using public conveyances--planes, trains, Ubers--it might appear that the mandate was rather "closely related to the powers granted" to the federal health authorities by law. Indeed, it appears, at any blush, to be intimately related, which is why the ruling issued by Mizelle, a federal district-court judge based in Tampa, Florida, is so alarming. The Public Health Service Act of 1944 gives federal health authorities broad powers "to prevent the introduction, transmission, or spread of communicable diseases" by means of interstate modes of transport, and to do so by establishing rules related to "inspection, fumigation, disinfection, sanitation, pest extermination, destruction of animals or articles found to be so infected or contaminated as to be sources of dangerous infection to human beings," as well as by "other measures" that in their "judgment may be necessary." Mizelle's ruling, which inspired social-media videos of people gleefully unmasking on airplanes, was sudden and startlingly broad. She did not rely on narrow ground such as the fact that, at this stage in the COVID-19 crisis, hospitalization rates are low and vaccines are widely available, and so a transportation mask mandate might no longer be justified. Instead, she found that the Centers for Disease Control and Prevention never had the power to issue such a mandate and thus would not be able to do so in the future, no matter the shape of a future pandemic.


AI Takes Bite Out of Dental Slide Misses by Assisting Doctors

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Your next trip to the dentist might offer a taste of AI. Pearl, a West Hollywood startup, provides AI for dental images to assist in diagnosis. It landed FDA clearance last month, the first to get such a go-ahead for dentistry AI. The approval paves the way for its use in clinics across the United States. "It's really a first of its kind for dentistry," said Ophir Tanz, co-founder and CEO of Pearl.


First FDA Approved AI Software Can Now Read Dental Xrays

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The Food and Drug Administration has approved the first artificial intelligence software to be used to interpret dental x-rays, allowing dentists to better screen for oral pathologies. Pearl's Second Opinion is the first and only FDA-cleared AI radiologic detection aid for dentists at the chairside, and it can assist dentists to discover a variety of common dental diseases such as tooth decay, calculus, and root abscesses. Pearl gathered over 100 million dental x-rays from dental practices and academic institutes to create Second Opinion. The AI platform highlights anomalies in x-rays and also acts as a patient communication tool, allowing dentists to exhibit alternative models of a patient's teeth and highlight trouble regions. Pearl's announcement is a significant step forward in the field of technology-assisted dentistry.


Federal judge blocks mask mandate for public transportation

FOX News

Gutfeld and guests discuss how the Biden administration is extending the federal mask mandate for another 15 days on'Gutfeld!' A federal judge on Monday voided the Biden administration's mask mandate for travelers using public transportation such as trains and airplanes. The mandate from the Centers for Disease Control and Prevention applies to people as young as 2 years old, and had been set to expire a number of times but was recently extended to May 3 before Monday's ruling. US COLLEGES REINSTATE MASK REQUIREMENTS, BUT EXPERT SAYS'THE TIME FOR MASK MANDATES IS GONE' The ruling from U.S.. District Court Judge Kathryn Kimball Mizelle, came in a case brought in Florida federal court by Health Freedom Defense Fund, Inc. and frequent air travelers Ana Daza and Sarah Pope against the administration. Judge Mizelle determined that the mandate violated the Administrative Procedure Act by being outside the scope of the CDC's authority, was "arbitrary" and "capricious" and not going through the required notice and comment period for federal rulemaking.


Aidoc Gets FDA 510(k) Clearance for AI-Powered Algorithm for Brain Aneurysms

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Could a new artificial intelligence (AI)-enabled advance have an impact in the diagnosis and treatment of brain aneurysms? The Food and Drug Administration (FDA) has granted 510(k) clearance to Aidoc's new AI platform for brain aneurysms. In addition to identifying and triaging suspected cases, the algorithm facilitates communication and workflow between radiologists, neurologists and neuroendovascular surgeons, according to the company. Researchers have estimated that approximately 6.5 million people in the United States have an unruptured brain aneurysm.1 The Brain Aneurysm Foundation has noted that most aneurysms are small, ranging from 1/8 inch to an inch, and ruptured aneurysms are reportedly misdiagnosed or there is a delay in diagnosis in 25 percent of patients who present to health-care providers.1 Elad Walach, the CEO and co-founder of Aidoc, said the new AI-enabled algorithm may help enhance timely diagnosis and care for brain aneurysms.


La veille de la cybersécurité

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An artificial intelligence tool that reads chest X-rays without oversight from a radiologist got regulatory clearance in the European Union last week -- a first for a fully autonomous medical imaging AI, the company, called Oxipit, said in a statement. It's a big milestone for AI and likely to be contentious, as radiologists have spent the last few years pushing back on efforts to fully automate parts of their job. The tool, called ChestLink, scans chest X-rays and automatically sends patient reports on those that it sees as totally healthy, with no abnormalities. Any images that the tool flags as having a potential problem are sent to a radiologist for review. Most X-rays in primary care don't have any problems, so automating the process for those scans could cut down on radiologists' workloads, the Oxipit said in informational materials.


First autonomous X-ray-analyzing AI is cleared in the EU

#artificialintelligence

An artificial intelligence tool that reads chest X-rays without oversight from a radiologist got regulatory clearance in the European Union last week -- a first for a fully autonomous medical imaging AI, the company, called Oxipit, said in a statement. It's a big milestone for AI and likely to be contentious, as radiologists have spent the last few years pushing back on efforts to fully automate parts of their job. The tool, called ChestLink, scans chest X-rays and automatically sends patient reports on those that it sees as totally healthy, with no abnormalities. Any images that the tool flags as having a potential problem are sent to a radiologist for review. Most X-rays in primary care don't have any problems, so automating the process for those scans could cut down on radiologists' workloads, the Oxipit said in informational materials.


Meet the new AI cancer doctors

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Algorithms are increasingly being put to work alongside radiologists and pathologists to help detect and diagnose cancers. Why it matters: AI developers say these tools can help relieve a stressed health care system and improve critical medical decision-making, but experts caution about the risk of overdiagnosis that could drive up health spending and bring the possibility of unnecessary, risky biopsies. Where it stands: Since the FDA began regulating algorithms as medical devices a few years ago, there's been a surge in computer models developed to help detect and diagnose cancer and to assist in prioritizing the workflow of radiologists. The next frontier for AI in cancer pathology is to use biological markers "to predict a clinical outcome that we don't easily predict today," says David Klimstra, the chief medical officer and co-founder of PaigeAI. Keep in mind: FDA clearance is a lower bar than FDA approval when it comes to medical devices, including AI. Yes, but: There is a risk of false positives and unnecessary treatment.