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BioWorld - Thursday, July 30, 2026
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2019 Medical Innovation Summit

Mitral valve surgery, osteoporosis drug top Cleveland Clinic's annual list

Oct. 24, 2019
By Liz Hollis
CLEVELAND – The list is out, and a dual-acting osteoporosis drug and a device for expanding the use of minimally invasive mitral valve surgery have come out on top. That's according to a panel of doctors and researchers who develop the highly anticipated Top 10 annual list of medical innovations looking to transform patient care, revealed at the Cleveland Clinic's Medical Innovation Summit.
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H.R. 3 continues its race through U.S. House

Oct. 23, 2019
By Mari Serebrov
In another marathon session Tuesday, the third U.S. House committee with jurisdiction over prescription drug pricing issues marked up H.R. 3, the Lower Drug Costs Now Act, clearing the way for a House vote on the partisan measure yet this month.
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UCSF, Berkeley researchers develop brain bleed algorithm that bests expert radiologists

Oct. 23, 2019
By Stacy Lawrence
Radiologists review thousands of images a day. The hope is that artificial intelligence (AI) applications will become useful soon to verify diagnoses, prioritize queued images and even to offer a level of detection and measurement that aren't feasible for humans. One of the latest efforts on this front is by researchers at the University of California at San Francisco (UCSF) and the University of California at Berkeley.
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MAUDE takes another hit over adverse events for Sapien 3, Mitraclip

Oct. 23, 2019
By Mark McCarty
A recent medical journal article says the terminology used by physicians to denote a fatality in the FDA adverse event reporting system has led to underreporting of fatalities associated with two prominent cardiology devices, a predicament the authors say skews the public understanding of these devices' safety profiles.
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Philips, DoD develop AI-based predictive algorithm for early infection detection

Oct. 23, 2019
By Meg Bryant
Diagnosis and treatment of infections typically occurs after people exhibit obvious signs of illness, such as fever or a cough. By then, they may already have exposed others and are well on the way to developing more serious symptoms themselves. In the military, such delays can hamper medical countermeasures to contain potential outbreaks and reduce downtime among active duty personnel. Now, Amsterdam-based Royal Philips NV and the U.S. Department of Defense's Defense Threat Reduction Agency and Defense Innovations Unit have built an early warning algorithm – using artificial intelligence – to detect infection before a person shows any signs or symptoms of infection.
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Little predictability in IRB use of 'appropriate local committees'

Oct. 22, 2019
By Mark McCarty
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.
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Canon Medical nabs FDA OK for AI-enhanced Aquilion Precision CT

Oct. 22, 2019
By Meg Bryant
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.
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Penn researchers develop neoantigen quality algorithm to guide immunotherapy

Oct. 21, 2019
By Stacy Lawrence
Researchers at the Abramson Cancer Center at the University of Pennsylvania have developed an algorithm to better personalize immunotherapy treatment. The algorithm works by examining neoantigen quality, not just their quantity. Neoantigens are proteins that are the result of genetic mutations in a tumor.
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Consensus impossible on H.R. 3 given congressional divide

Oct. 18, 2019
By Mari Serebrov
The ideological divide between Republicans and Democrats proved to be an uncrossable chasm Thursday as two U.S. House committees marked up H.R. 3, the Lower Drug Costs Now Act, and a third committee held its first hearing on the bill that was crafted behind the closed doors of Speaker Nancy Pelosi's (D-Calif.) office.
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FDA adcom to review Shionogi’s cefiderocol to treat cUTIs

Oct. 16, 2019
By Michael Fitzhugh
Briefing documents released ahead of Wednesday’s meeting of the FDA’s Antimicrobial Drugs Advisory Committee, slated to review Shionogi & Co. Ltd.’s cefiderocol for treatment of complicated urinary tract infections (cUTIs), spotlighted a finding of increased mortality among critically ill cefiderocol-treated patients in the company’s Credible-CR study.
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