Tag: FDA

GAO urges HHS to improve drug shortage response coordination

Editor's Note The Government Accountability Office (GAO) has called on the Department of Health and Human Services (HHS) to implement a formal mechanism for coordinating efforts to address ongoing drug shortages, which continue to jeopardize patient care nationwide. In a report released April 9, 2025, the GAO highlighted the critical…

Read More

By: Matt Danford
April 10, 2025
Share

FDA clears AI platform for real-time surgical measurements

Editor's Note What is reportedly the first technology to allow dynamic, 3D, segmental visualization of anatomy during surgery earned a second 510(k) clearance from the US Food and Drug Administration, according to an April 8 press release from developer Proprio. Designed to let surgeons measure progress during surgery without scrubbing…

Read More

By: Matt Danford
April 9, 2025
Share

Study: MRI contrast agent causes harmful metal buildup in some patients

Editor's Note New research offers a potential explanation for why some patients retain toxic metals long after undergoing an MRI. Published in the journal Magnetic Resonance Imaging, the findings show that gadolinium contrast agents used in MRI scans may react with common dietary compounds to form harmful metal nanoparticles in…

Read More

By: Matt Danford
April 9, 2025
Share

FDA issues Class 1 recall for vascular cannulas

Editor's Note Aortic root cannulas from Medtronic are the subject of the latest US Food and Drug Administration (FDA) class 1 recall, the most serious category reserved for risk of injury or death. Affected products include the DLP Aortic Root Cannula, MiAR Cannula, and DLP Aortic Root Cannula with Vent…

Read More

By: Matt Danford
April 1, 2025
Share

FDA announces Class 1 recall for implantable ports

Editor's Note The US Food and Drug Administration (FDA) has deemed Smiths Medical’s recall of Proport Plastic Implantable Ports a Class 1, the most severe designation indicating serious risk of injury or death. The devices are designed for repeated venous access for injections, infusions, and/or blood samples. According to the…

Read More

By: Matt Danford
March 20, 2025
Share

Infusion pumps deemed high-risk in FDA early alert

Editor's Note Baxter Healthcare Corporation has issued a letter to affected customers recommending certain Spectrum infusion pumps be removed from where they are used or sold, according to a March 5 early alert from the US Food and Drug Administration (FDA). The FDA notice concerns the Sigma Spectrum Infusion System…

Read More

By: Matt Danford
March 5, 2025
Share

FDA announces Class 1 endovascular system, anesthesia system recalls

Editor's Note The US Food and Drug Administration (FDA) designated Getinge’s recall of Vaporizer Sevoflurane Maquet Filling and Sevoflurane Quick-Fil and Philips’ recall of Tack Endovascular Systems as Class 1s, the most severe category indicating serious risk of injury or death. The Getinge recall is an expansion of a 2024…

Read More

By: Matt Danford
March 3, 2025
Share

Robotic surgery transforms ORs as market expands

Editor's Note A February 21 article in Modern Healthcare details how surgical robots are delivering faster procedures, improving patient outcomes, and boosting hospital profits. As detailed in the article, the global surgical robotics market has quadrupled since 2015, growing from $800 million to approximately $3 to $3.5 billion in 2023…

Read More

By: Matt Danford
February 25, 2025
Share

FDA designates Class 1 recall for pacemakers

Editor’s Note The US Food and Drug Administration (FDA) has designated Boston Scientific Corporation’s recall of Accolade Pacemaker devices a Class 1, the most severe category indicating serious risk of injury or death. According to the agency’s February 21 announcement, the recall was motivated by a manufacturing issue that could…

Read More

By: Matt Danford
February 24, 2025
Share

Session: Navigating the Storm: Ensuring Operational Continuity Through Crisis Leadership

Editor's Note In an expansive session at the 2025 OR Business Management Conference, Tampa General Hospital's emergency management team demonstrated how proactive planning, strong partnerships, and real-time decision-making helped navigate multiple crises in 2024, including back-to-back hurricanes and a cyberattack on the state's blood supply. The session was presented by Erinn…

Read More

By: Matt Danford
February 13, 2025
Share

Join our community

Learn More
Video Spotlight
Live chat by BoldChat