Recalls and Warnings: Risk Management Considerations
From time to time, the FDA, manufacturers, and other agencies issue recalls or serious warnings about devices, drugs, instruments and other healthcare-related products. When one of these notices impacts your medical practice, it is important to follow a comprehensive process and document all the steps you have undertaken to avoid potential liability…
CDC and FDA Launch Investigation Into Infant Botulism Associated With Recalled Formula
The Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) are currently investigating a multistate outbreak of infant botulism linked to ByHeart Whole Nutrition Infant Formula sold during July 2025 to November 2025 in-store and online. Retailers with stores in Nebraska selling ByHeart Whole Nutrition Infant Formula include Walmart, Target, and Whole Foods Market.
Device Invented by Local Physician Receives FDA Clearance
Virginia-based medical device company Liquet Medical Inc. has received 510(k) clearance from the U.S. Food and Drug Administration for its Versus™ Catheter, a device patented by Sanford Health and invented by vascular surgeon Patrick Kelly, MD…
University Of Nebraska Medical Center’s Munroe-Meyer Institute Pilots New Autism Diagnostic Tool
The Munroe-Meyer Institute at the University of Nebraska Medical Center is piloting a new diagnostic tool that could dramatically cut waitlists for an autism diagnosis.
Glaucoma Awareness Month
Glaucoma is a silent disease causing irreversible damage to the optic nerve and there’s a new treatment FDA approved in time for Glaucoma Awareness Month. “Early detection and early intervention through updated treatment options are key to preventing vision loss,” says Dr. Deborah Gess Ristvedt, an ophthalmologist at Vance Thompson Vision’s Alexandria, MN location.
AMA Statement On FDA Delaying Rule Banning Menthol Cigarettes
The following statement is attributable to: Jesse M. Ehrenfeld, M.D., M.P.H.
President, American Medical Association
Sanford Sioux Falls Seeks Input On Blood Loss Clinical Trial
Bleeding out is the most common cause of preventable death after injury. Researchers at Sanford Health are asking for community input on whether they should participate in an international study. The study will see if a blood clotting drug, given soon after arrival in the emergency department, can improve survival.
Sanford Fargo Seeks Input On Blood Loss Clinical Trial
Bleeding out is the most common cause of preventable death after injury. Researchers at Sanford Health are asking for community input on whether they should participate in an international study. The study will see if a blood clotting drug, given soon after arrival in the emergency department, can improve survival.
Bivalent COVID-19 Vaccine Recommendation Expands To Include Children Ages 6 Months Through 5 Years
Last week, following authorization by the U.S. Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC) recommended expanded use of the bivalent COVID-19 vaccine to children ages 6 months through 5 years.
Local Ophthalmologist Played Lead Role in FDA Approval of New Eye Drops
Sioux Falls ophthalmologist Dr. Vance Thompson says he was honored to serve as principal investigator in the clinical trial of a newly-approved eye drop for age-related blurry near vision.