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.

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In the elegant quiet of the café at the Church of Sweden, a narrow Gothic-style building in Midtown Manhattan, Daniel Cohen is taking a break from explaining genetics. He moves toward the creaky piano positioned near the front door, sits down, and plays a flowing, flawless rendition of "Over the Rainbow." If human biology is the scientific equivalent of a complicated score, Cohen has learned how to navigate it like a virtuoso. Cohen was the driving force behind Généthon, the French laboratory that in December 1993 produced the first-ever "map" of the human genome. He essentially introduced Big Data and automation to the study of genomics, as he and his team demonstrated for the first time that it was possible to use super-fast computing to speed up the processing of DNA samples.

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Learning Practice for Medical Device Development: Guiding Principles, published in October 2021; and the just-released draft guidance, Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions.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.

MARSEILLE, France and PROVIDENCE, R.I., April 27, 2022 (GLOBE NEWSWIRE) -- Volta Medical, a pioneering medtech startup advancing novel artificial intelligence (AI) algorithms to treat cardiac arrhythmias, today announced it will participate at Heart Rhythm 2022, where Volta VX1 digital AI companion technology will be featured in several venues, including a poster session, podium presentation, Rhythm Theater program and the Volta exhibit booth. VX1 is a machine and deep learning-based algorithm designed to assist operators in the real-time manual annotation of 3D anatomical and electrical maps of the human atria during atrial fibrillation (AF) or atrial tachycardia. It is the first FDA cleared AI-based tool in interventional cardiac electrophysiology (EP). On Friday, April 29, VX1 will be highlighted in two scientific sessions: session DH-202, "Machine Learning Applications for Arrhythmia Detection and Treatment" from 10:30-11:30 a.m. Volta's Rhythm Theater presentation, "Can AI Solve the Persistent AF Paradigm?," will be held Saturday, April 30 from 10:00-11:00 a.m.

AI developers are keen on DA imaging analysis, and the only secret is more AI. The Israel-based company has already received some FDA approvals for AI technology executives and is now planning to use Intel's own detailed learning plan to enhance its software analytics capabilities. In a collaboration announced this week, DIA announced that it will use Intel's OpenVINO toolkit to reduce processing time for its Lvvo seamless echocardiography platform. Using an AI solution like LVivo, Cardiac Ultrasound automatically moves to a hospital server, "behind the scenes" for visual selection and measurement. Includes multiple manual and visual procedures DIA CEO and co-founder Hila Goldman Aslan.

Biofourmis, a startup developing digital therapeutics and artificial intelligence to remotely monitor patients, said its valuation hit $1.3 billion after raising a $300 million Series D funding round led by General Atlantic. The Boston-based company said CVS Health joined the round, along with existing investors, and also announced Omar Ishrak, chairperson of Intel and former CEO of Medtronic, will chair its board. Biofourmis had previously raised a $100 million round in September 2020 led by SoftBank Investment Advisers at an undisclosed valuation. This Series D round brings the company's total funding to $445 million. Originally based in Singapore, Biofourmis moved its headquarters to the United States in 2019.

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.

Artificial intelligence (AI) solutions that automatically extract information from digital histology images have shown great promise for improving pathological diagnosis. Prior to routine use, it is important to evaluate their predictive performance and obtain regulatory approval. This assessment requires appropriate test datasets. However, compiling such datasets is challenging and specific recommendations are missing. A committee of various stakeholders, including commercial AI developers, pathologists, and researchers, discussed key aspects and conducted extensive literature reviews on test datasets in pathology. Here, we summarize the results and derive general recommendations for the collection of test datasets. We address several questions: Which and how many images are needed? How to deal with low-prevalence subsets? How can potential bias be detected? How should datasets be reported? What are the regulatory requirements in different countries? The recommendations are intended to help AI developers demonstrate the utility of their products and to help regulatory agencies and end users verify reported performance measures. Further research is needed to formulate criteria for sufficiently representative test datasets so that AI solutions can operate with less user intervention and better support diagnostic workflows in the future.

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.