CLEVELAND – Monday featured a big announcement during the 2019 Medical Innovation Summit, with the Cleveland Clinic and American Well revealing that they are partnering to create a joint venture (JV) focused on telehealth. The venture, dubbed The Clinic for now, was conceived "in order to achieve our joint vision and our ambitions in how to revise the delivery of care and to be at the forefront of it," said Semih Sen, chief business development officer, Cleveland Clinic, as part of a keynote delivered by Roy Schoenberg, president and CEO of Boston-based American Well. Read More
The U.S. FDA has given 510(k) clearance to the Advanced Intelligent Clear-IQ Engine (AiCE) for Canon Medical Systems USA Inc.'s Aquilion Precision CT scanner. The regulatory green light brings artificial intelligence (AI)-based image reconstruction capabilities to the world's first ultra-high resolution CT imaging system. Read More
The FDA's September 2019 final guidance for the humanitarian device exemption program brought some clarity to several issues, but device makers must still untangle the question of which tasks an institutional review board (IRB) has delegated to an appropriate local committee for a specific clinical site. Read More
LONDON – A U.K. national plan to upgrade population cancer screening will see greater adoption of genomics and biomarker-based testing, and the use of artificial intelligence to help interpret results. There will be moves to make it easier to pilot and adopt novel diagnostics and to do more targeted screening to identify and follow people who are shown to be at greater risk of developing specific types of cancer. Read More
BOGOTA, Colombia – A Costa Rican designer developed a system to create tailor-made molds to treat patients diagnosed with microtia, a congenital deformity, in which the external ear is not fully developed. "This is a very basic concept, and it really amazes me that it has not been implemented before," Andrés Quiros, the product designer behind the invention, told BioWorld MedTech. Read More