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Hype and science collide as FDA tries to rein in 'wild West' of COVID-19 blood tests

Los Angeles Times

"Save your business while saving lives," reads the website of Because Health, a Seattle tech start-up selling two types of tests to employers willing to pay $350 a pop to learn whether their workers have been infected with COVID-19. The company's "Workplace Health" plan includes not only nasal swab tests to detect infection, but also blood tests aimed at determining whether workers have developed antibodies to the virus -- and, possibly, future protection. "There's a tremendous consumer demand," said Dr. Lars Boman, the firm's Boston-based medical director. "Can they return to work? Can they return to life?"


Coronavirus Testing: FDA Approves Quicker, Cheaper New Antigen Test

International Business Times

In its first use of emergency authorization, the U.S. Food and Drug Administration (FDA) on Friday approved the production of a new coronavirus antigen test category. These tests will be able to track antigen proteins using naval cavity samples collected with swabs. With these tests, medical professionals can detect the presence of COVID-19 antigens in a matter of minutes. They are also much cheaper to produce than the tests currently in use. While much quicker, these new tests are unable to track as many infections as the standard polymerase chain reaction tests and are more likely to deliver false negatives.


Pear Therapeutics Expands Pipeline with Machine Learning, Digital Therapeutic and Digital Biomarker Technologies - Pear Therapeutics

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Boston and San Francisco, January 7, 2020 – Pear Therapeutics, Inc., the leader in Prescription Digital Therapeutics (PDTs), announced today that it has entered into agreements with multiple technology innovators, including Firsthand Technology, Inc., leading researchers from the Karolinska Institute in Sweden, Cincinnati Children's Hospital Medical Center, Winterlight Labs, Inc., and NeuroLex Laboratories, Inc. These new agreements continue to bolster Pear's PDT platform, by adding to its library of digital biomarkers, machine learning algorithms, and digital therapeutics. Pear's investment in these cutting-edge technologies further supports its strategy to create the broadest and deepest toolset for the development of PDTs that redefine standard of care in a range of therapeutic areas. With access to these new technologies, Pear is positioned to develop PDTs in new disease areas, while leveraging machine learning to personalize and improve its existing PDTs. "We are excited to announce these agreements, which expand the leading PDT platform," said Corey McCann, M.D., Ph.D., President and CEO of Pear.


FDA Grants Caption Health Landmark Authorization

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Caption Health, a leading medical AI company, announced that the US Food and Drug Administration (FDA) authorized marketing of Caption Guidance, software that assists medical professionals in the acquisition of cardiac ultrasound images. Caption Guidance uses artificial intelligence to provide real-time guidance and diagnostic quality assessment of images, empowering healthcare providers--even those without prior ultrasound experience--with the ability to capture diagnostic quality images. Empowering more clinicians with ultrasound image acquisition capability will bring the benefits of ultrasound to more patients, help standardize the quality of care, and help institutions realize valuable cost and time savings. Caption Guidance was authorized via the De Novo pathway, a regulatory pathway reserved for novel technologies. The granting of this De Novo is groundbreaking, as Caption Guidance is the first medical software authorized by the FDA that provides real-time AI guidance for medical imaging acquisition.


Using Artificial Intelligence to Combat Revenue Cycle Inefficiencies - Electronic Health Reporter

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Hospitals and health systems throughout the country are constantly looking for ways to streamline finances and fine tune operating margins. Many are now looking outside the box for solutions to help increase their operating revenue and combat the continued pressure to stretch budgets to include data security, attracting top talent and facility upgrades. Artificial Intelligence (AI), as an example, is showing promising results in healthcare to more effectively address revenue cycle inefficiencies. AI has penetrated nearly every touchpoint in medicine, from the way emergency medical technicians (EMTs) are dispatched to assisting physicians during surgery. AI is enabling smart devices to detect cancer or a stroke, and consumers can even get help to quit smoking or address opioid addictions with the help of AI.


Pear Therapeutics Expands Pipeline with Machine Learning, Digital Therapeutic and Digital Biomarker Technologies

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BOSTON & SAN FRANCISCO--(BUSINESS WIRE)--Pear Therapeutics, Inc., the leader in Prescription Digital Therapeutics (PDTs), announced today that it has entered into agreements with multiple technology innovators, including Firsthand Technology, Inc., leading researchers from the Karolinska Institute in Sweden, Cincinnati Children's Hospital Medical Center, Winterlight Labs, Inc., and NeuroLex Laboratories, Inc. These new agreements continue to bolster Pear's PDT platform, by adding to its library of digital biomarkers, machine learning algorithms, and digital therapeutics. Pear's investment in these cutting-edge technologies further supports its strategy to create the broadest and deepest toolset for the development of PDTs that redefine standard of care in a range of therapeutic areas. With access to these new technologies, Pear is positioned to develop PDTs in new disease areas, while leveraging machine learning to personalize and improve its existing PDTs. "We are excited to announce these agreements, which expand the leading PDT platform," said Corey McCann, M.D., Ph.D., President and CEO of Pear.


Waystar Acquires AI Firm Digitize.AI to Tackle Prior Authorizations -

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Bain-Capital-backed revenue cycle management company Waystar is acquiring Digitize.AI, an artificial intelligence firm, to enable faster and smarter prior authorizations in healthcare – one of the largest pain points for both providers and consumers. Prior authorizations, the process by which insurance companies and payers determine if they will cover a prescribed procedure or medication, are meant to help patients avoid surprise bills and unexpected out-of-network costs. Prior authorization volume in the healthcare industry has risen 54% in the last four years, causing pain for providers and health plans. The manual process is time-consuming and error-prone, resulting in a $30 billion annual cost in wrongful denials, inefficiencies and clerical errors. Founded in 2017 to tackle prior authorizations, Digitize.AI leverages the power of artificial intelligence and machine learning to automate prior authorizations, resulting in faster authorizations, at less cost, and with fewer denials.


Visa uses AI to prevent $25bn in fraud

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Visa has announced new analysis showing Visa Advanced Authorization (VAA) using artificial intelligence (AI) helped financial institutions around the world prevent an estimated $25 billion in annual fraud. VAA is a comprehensive risk management tool that monitors and evaluates transaction authorizations on the Visa global payment network, VisaNet, in real time to help financial institutions promptly identify and respond to emerging fraud patterns and trends. Visa processed more than 127 billion transactions between merchants and financial institutions on VisaNet last year and employed AI to analyze 100 percent of the transactions--each in about one millisecond--so financial institutions can approve legitimate purchases while quickly identifying and preventing fraudulent transactions. "One of the toughest challenges in payments is separating good transactions made by account holders from bad ones attempted by fraudsters without adding friction to the process," said Melissa McSherry, senior vice president and global head of Data, Risk and Identity Products and Solutions, Visa. "Visa was the first payment network to apply neural network-based AI in 1993 to analyze the riskiness of transactions in real time, and the impact on fraud was immediate. By striking the right balance between human expertise and technology innovation, we continue to evolve our capabilities as new AI breakthroughs expand the realm of what's possible."


Using Artificial Intelligence, Visa Is Combatting Fraud at Nearly the Speed of Light

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By using artificial intelligence (AI), Visa Inc. helped issuers prevent an estimated $25 billion in annual fraud, the company announced on June 17. The company accomplished this using Visa Advanced Authorization (VAA), a comprehensive risk management tool that monitors transaction authorization on the Visa global network, VisaNet, in real time. VAA evaluates every single transaction on VisaNet and helps issuers swiftly identify emerging fraud trends and patterns, allowing the issuers to respond promptly to instances of fraud, while approving legitimate transactions. "One of the toughest challenges in payments is separating good transactions made by cardholders from bad ones attempted by fraudsters without adding friction to the process," said Melissa McSherry, senior vice president and global head of Data Products and Solutions at Visa. The speed with which Visa can evaluate a transaction is crucial.


PYMNTS.com

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Visa has rolled out internal data that indicates its artificial intelligence (AI)-based Advanced Authorization (VAA) security product has helped issuers prevent an estimated $25 billion in annual fraud. VAA is a risk management tool that monitors and evaluates transactions over VisaNet in real time to helps issuer "see" fraud as it happens and shut it down based on its ability to spot emerging fraud patterns and trends. Over 127 billion transactions flowed across VisaNet in 2018 between merchants and financial institutions on VisaNet last year, and AI was used to analyze 100 percent of those transactions. Each bit of analysis and fraud ranking takes about one millisecond -- so financial institutions can approve legitimate and bounce bad ones without the customer ever feeling a delay. "One of the toughest challenges in payments is separating good transactions made by cardholders from bad ones attempted by fraudsters without adding friction to the process," said Visa Senior Vice president and Global Head of Data Products and Solutions Melissa McSherry.