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.

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.

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.

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.

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.

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.

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.

CEO Mark McKenna told BioWorld Asia that San Diego-based Prometheus Biosciences Inc. has "cracked the code" in inflammatory bowel disease (IBD) – progress underscored by the firm's deal with Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, which brings an undisclosed up-front payment and as much as $420 million more if development, regulatory and commercial milestones are reached in three programs.

WASHINGTON – Hot on the heels of July's FDA approval of Recarbrio (imipenem, cilastatin and relebactam) in complicated urinary tract infections (cUTIs), Merck & Co. Inc. rolled out pivotal phase III data at the Infectious Disease Society of America's IDWeek 2019 that could support expanding its label to another high-need group, people with hospital-acquired or ventilator-associated bacterial pneumonia (HABP/VABP).

The FDA has granted 510(k) clearance to the first hernia mesh featuring a nanometer-level surface texture, enabling better post-implant tissue ingrowth and reducing the incidence of adverse reactions. The Exogenesis Hernia Mesh, by Billerica, Mass.-based Exogenesis Corp., is indicated for the repair of abdominal wall hernias and deficiencies that require reinforcement to stabilize the condition and achieve a positive surgical outcome. The company expects to launch the product nationwide in 2020.