Surgery/Specialties
FDA: Class I recall of Abbott Amplatzer Steerable Delivery Sheath
Editor's Note The Food and Drug Administration (FDA), on July 26, identified the recall by Abbott of its Amplatzer Steerable Delivery Sheath as Class I, the most serious. Abbott is recalling the sheath because of an increased risk for air emboli being introduced into patients who have cardiac catheterization procedures…
ACS: 19 surgical organizations oppose CMS code G2211
Editor's Note The American College of Surgeons (ACS) announced, on July 26, that it and 18 other surgical organizations sent a letter to the Centers for Medicare & Medicaid Services (CMS), strongly opposing implementation of its code G2211. The G2211 code is an effort by CMS to pay more for…
Military combat surgeon to lead new pandemic preparedness office
Editor's Note Paul Friedrichs, MD, a military combat surgeon and retired Air Force major general, will lead the new Office of Pandemic Preparedness and Response Policy, which will replace the current COVID-19 and monkeypox response teams, and prepare for future pandemics, the July 21 Reuters reports. Dr Friedrichs will be…
Does a ‘weekend warrior’ physical activity pattern prevent cardiovascular disease?
Editor's Note This study by researches at the Massachusetts General Hospital, Boston, and the Broad Institute of MIT and Harvard, Cambridge, Massachusetts, examines whether moderate to vigorous physical activity concentrated in 1 to 2 days of the week (ie, a “weekend warrior” pattern) confers similar cardiovascular benefits as more evenly…
First robotic liver transplant in US performed at Barnes-Jewish Hospital
Editor's Note Washington University School of Medicine, on July 12, announced that a team of its surgeons performed the first robotic liver transplant in the US in May at Barnes-Jewish Hospital, St Louis. The patient, a man in his 60s who needed a transplant because of liver cancer and cirrhosis…
FDA: Class I recall of Quidel Triage Cardiac Panels
Editor's Note The Food and Drug Administration (FDA), on July 17, identified the recall by Quidel Cardiovascular Inc of its Quidel Triage Cardiac Panels as Class I, the most serious. The recall was initiated because of reports of inaccurate tests showing lower than expected troponin levels in samples. A falsely…
Discrepancies in FDA clearance, marketing of AI-, ML-enabled medical devices
Editor's Note This study from New York University and NYU Langone Health, New York City, finds discrepancies between the marketing and 510(k) clearance of artificial intelligence (AI)- or machine learning (ML)-enabled medical devices, with some devices being marketed as having capabilities not approved by the Food and Drug Administration (FDA).…
FDA: Class I recall of Medtronic implantable cardioverter, cardiac resynchronization therapy defibrillators
Editor's Note The Food and Drug Administration (FDA), on July 18, identified the recall by Medtronic of its implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) as Class I, the most serious. Medtronic is recalling all ICDs and CRT-Ds, with glassed feedthroughs that were manufactured after 2017, as…
FDA: Class I recall of Draeger Medical’s Oxylog 3000 Plus Emergency and Transport Ventilators
Editor's Note The Food and Drug Administration (FDA), on July 13, identified the recall by Draeger Medical of its Oxylog 3000 Plus Emergency and Transport Ventilators as Class I, the most serious. The recall was initiated because of reports that the ventilator may not automatically switch back to using AC…
The Joint Commission/AHA revise requirements for Advanced Certification in Heart Failure program
Editor's Note The Joint Commission, on July 12, announced that it and the American Heart Association (AHA) have revised requirements for the Advanced Certification in Heart Failure program to align with the latest clinical practice guidelines for heart failure, effective January 1, 2024. Requirements for interdisciplinary team members have been…
Free Daily News
- Robotic surgery transforms ORs as market expands
- Study: Wildfire smoke raises hospital borrowing, patient care costs
- Study: Hospital bed shortage looms as aging population drives demand
- FDA designates Class 1 recall for pacemakers
- Chinese medical devices threaten US healthcare cybersecurity
- Preoperative SGLT2i use does not raise DKA risk in emergency surgery
- AI boosts accuracy in surgical reports, outperforming surgeons
- AI models improve prediction of surgical complications using preoperative clinical notes
- Ambient AI healthcare documentation gains traction as capabilities expand
- Healthcare M&A faces tighter review as FTC retains guidelines