Researchers argue that the national, centralized regulation of clinical artificial intelligence (AI) is not sufficient and instead propose a hybrid model of centralized and decentralized regulation. In an opinion piece published in PLOS Digital Health, public health researchers at Harvard note that the increase in clinical AI applications, combined with the need to adapt applications to account for differences between local health systems, creates a significant challenge for regulators. Currently, the US Food and Drug Administration (FDA) regulates clinical AI under the classification of software-based medical devices. Medical device approval is typically obtained via premarket clearance, de novo classification, or premarket approval. In practice, this usually involves the approval of a "static" model, meaning that any change in data, algorithm, or intended use after initial approval requires reapplication for approval.

GreyOrange announced an agreement with Blue Yonder to leverage their combined digital warehouse management system (WMS) and order management system (OMS) solutions to speed up fulfillment modernization for joint customers. Together, GreyOrange and Blue Yonder provide the broadest range of options for businesses focused on fulfillment as a competitive edge. Real-time orchestration and management of entire robotic fleets enable substantial increases in fulfillment throughput and accuracy across the ecosystem. "Blue Yonder's warehouse management and order management solutions are recognized by industry analysts as best-in-class and the brands they serve are market leaders," said Lesley Simmonds, vice president, global business development and alliances, GreyOrange. "We are looking forward to bringing the powerful combination of software and robots in our fulfillment platform and Blue Yonder's warehouse management and order management solutions to companies that want to use modern fulfillment as a strategic advantage that dramatically improves customer service as well as cost-efficiency."

Pharmaceutical manufacturers are increasingly interested in the tenets of Industry 4.0, including the use of digital twins to simulate, test and optimize manufacturing processes on a computer before using them in production, according to technology advisory firm ABI Research. It projects spending by pharmaceutical manufacturers on data analytics tools--including the digital twin -- to grow by 27% over the next seven years, to reach $1.2 billion in 2030. As with other manufacturers, pharmaceutical makers plan to use the digital tools to boost productivity and to track their operations. Toronto-based Basetwo recently moved into this market with its software-as-a-service (SaaS) artificial intelligence (AI) platform. Today, the year-old company announced an upcoming $3.8 million seed financing round led by Glasswing Ventures and Argon Ventures.

I sat in a dark room, eyes closed, with a device strapped to my head that looked like a futuristic bike helmet. For 10 minutes, while I concentrated on not accidentally opening my eyes, the prongs sticking out of this gadget and onto my scalp measured a health marker I never thought to assess: my cognitive health. When I booked my brain wave recording (also known as electroencephalography, or EEG), I expected to pull up to an office park with medical clinic vibes, but instead my GPS led me to an ocean-view storefront decorated like a cross between a surf shop and a luxury spa, with a sign in the window promising "Mental Wellness, Reimagined." Located in Cardiff-by-the-Sea, a wealthy coastal town north of San Diego, Wave Neuroscience promises to help your brain perform better with a noninvasive treatment that uses magnets on the brain. We're talking mental clarity, improved focus and concentration, and even a shift in mood.

The more recent of these came in 2020 for a machine learning algorithm that can analyze non-contrast brain CT scans and pinpoint early signs of …

This partnership will help health systems address the increasing volume of medical images and the worldwide radiologist labor shortage. Integration of Boneview into Aidoc's AI platform will give many more clinicians access to a tool to help them identify fractures in limbs, pelvis, thoracic and lumbar spine, and rib cage. Aidoc's end-to-end AI platform already includes numerous third-party AI vendors including Imbio, Riverain, Subtle, Icometrix and ScreenPoint. Over 152 million X-rays are performed every year in the US. Although there are about 37,000 radiologists in the US, they are not evenly distributed.

RapidAI's newly cleared artificial intelligence tool automatically analyzes CT pulmonary angiograms to detect signs of pulmonary embolism, …

After months of rumors, Google announced its own smartwatch, called the Pixel Watch, will be coming this fall. Although the tech giant has supported smartwatches through its wearable operating system and completed its acquisition of Fitbit last year, this is Google's first branded smartwatch. The Pixel Watch will have a circular, domed design made with recycled stainless steel and customizable bands. Even though the watch also has plenty of features not concerned with health tracking, Rick Osterloh, Google's senior vice president of devices and services, teased the Pixel Watch's "deep integration" with Fitbit that will include heart rate and sleep tracking as well as workout metrics users can measure against their goals. Meanwhile, Google is entering a crowded market for health-tracking wearables, with competitors like Apple, Amazon, Samsung, Withings and Garmin.

Fox News Flash top headlines are here. Check out what's clicking on Foxnews.com. The United States Food and Drug Administration (FDA) wants the public to be aware of counterfeit at-home over-the-counter (OTC) COVID-19 diagnostic tests circulating in the United States, according to a recent press release. "Counterfeit COVID-19 tests are tests that are not authorized, cleared, or approved by the FDA for distribution or use in the United States, but are made to look like authorized tests so the users will think they are the real, FDA-authorized test," the administration said. "The performance of these counterfeit tests has not been adequately established and the FDA is concerned about the risk of false results when people use these unauthorized tests." The at home diagnostic kits are primarily antigen tests.

Imagen enables Primary Care providers to become technology-enabled multispecialty practices, powering a successful transition from fee-for-service to value-based care. Imagen's comprehensive platform includes in-office diagnostic testing, diagnostic interpretations powered by proprietary FDA-cleared machine learning software, and virtual specialist consults. Imagen's platform empowers Primary Care providers to achieve healthcare's quadruple aim of increasing quality, lowering costs, and improving the patient and provider experience. Imagen's team includes over 100 clinical, technical and business personnel. Imagen's software has received first-of-its-kind FDA clearances, and its research has been published in leading peer-reviewed journals.