Regulations/Legal

Latest Issue of OR Manager
November 2024
Home Regulations/Legal

CMS calls for demonstrations of AI technology in healthcare

Editor's Note Aligning with a recent executive order promoting safe and effective use of artificial intelligence (AI) in healthcare, the Centers for Medicare & Medicaid Services (CMS) is seeking input on what providers and others are doing with the technology. Issued September 9, the Request for Information (RFI) invites healthcare…

Read More

By: Matt Danford
September 18, 2024
Share

FDA: Class 1 infusion system recall expanded

Editor's Note B. Braun Medical Inc. has expanded last year’s recall of lnfusomat Space Infusion Pump systems to include more models. Designated by the US Food and Drug Administration (FDA) as Class 1—the most serious category indicating risk of severe injury or death—the recall was motivated by the risk of…

Read More

By: Matt Danford
September 17, 2024
Share

FDA designates Class 1 recall for infusion system components

Editor's Note The US Food and Drug Administration (FDA) has designated Fresenius Kabi’s recall of certain Ivenix infusion system components as Class 1, the most severe category indicating risk of serious injury or death. According to the agency’s September 16 announcement, the recalled items consist of a certain lot (3010538)…

Read More

By: Matt Danford
September 16, 2024
Share

WHO, Joint Commission mark World Patient Safety Day

Editor's Note In partnership with the World Health Organization (WHO), The Joint Commission and The Joint Commission and Joint Commission International (JCI) invite organizations, health professionals, patients, and their advocates to recognize World Patient Safety Day Tuesday, September 17. This year’s theme is “improving diagnosis for patient safety.” This theme…

Read More

By: Matt Danford
September 16, 2024
Share

Sponsored Message

Joint Commission International launches healthcare sustainability certification for global organizations

Editor's Note Joint Commission International (JCI) and the International Hospital Federation's Geneva Sustainability Centre (GSC) have introduced a new Healthcare Sustainability Certification (HSC) for healthcare organizations outside the U.S., according to a September 11 report from The Joint Commission. The goal of the new initiative is to address the nearly…

Read More

By: Matt Danford
September 13, 2024
Share

Study: Right-sized donor livers scarce for female cancer patients

Editor's Note A recent study in JAMA Surgery showed women with hepatocellular carcinoma (HCC) were 8% less likely than men to receive a liver transplant and 6% more likely to die or be removed from the waitlist, Healio reported September 9.    The study, which analyzed 31,725 adults waitlisted for…

Read More

By: Matt Danford
September 13, 2024
Share

Sponsored Message

Study: Tubal ligation surgeries surged after abortion restrictions

Editor's Note Tubal ligation procedures increased after the 2022 overturn of Roe v. Wade and were particularly concentrated in states with abortion bans, according to a September 11 Associated Press (AP) report on a study published in JAMA. Researchers analyzed insurance claims for approximately 4.8 million women across 36 states…

Read More

By: Matt Danford
September 12, 2024
Share

Congressional hearing exposes US organ transplant system failures

Editor's Note Lost organs, widespread fraud, and live donors mistakenly presumed deceased are among the alarming issues with the US organ transplant system detailed in a recent Congressional hearing, MedPage Today reported September 11. As part of the House Energy & Commerce Oversight and Investigations Subcommittee, the hearing aimed to…

Read More

By: Matt Danford
September 12, 2024
Share

Trump-Harris debate highlights contrast on abortion, Affordable Care Act

Editor's Note The healthcare portion of the September 10 debate between former President Donald Trump and Vice President Kamala Harris focused on two issues: abortion and the Affordable Care Act (ACA).  Becker’s Hospital Review published key takeaways from the exchange September 11. According to the article, Trump reiterated that the…

Read More

By: Matt Danford
September 11, 2024
Share

Odin Medical’s AI-powered device for colonoscopy receives FDA clearance

Editor's Note Odin Medical, a subsidiary of Olympus Corporation, received Food and Drug Administration (FDA) 510(k) clearance for its cloud-based AI technology, the CADDIE™ computer-aided detection device, PRNewswire September 5 reports. Designed to assist gastroenterologists in detecting colorectal polyps during colonoscopy, the AI-powered system analyzes real-time video footage and alerts…

Read More

By: Tarsilla Moura
September 11, 2024
Share

Join our community

Learn More
Video Spotlight
Live chat by BoldChat