The Food and Drug Administration (FDA) has announced a Class I recall of the Medtronic Valiant Navion Thoracic Stent Graft System due to stent fractures and endoleak concerns.
Hayes News
Hayes News Service keeps our clients up to date with late-breaking news from clinical trials, coverage decisions, and new product approvals. We focus on emerging technologies with potentially high clinical and financial impact as soon as they are announced publicly.
Our analysts scan more than 75 peer-reviewed journals and news briefings from government agencies, medical associations, and research institutes. Results of selected studies or articles are summarized and posted with a brief commentary on whether the findings are likely to have a substantial impact.
FDA Safety Alerts
The Food and Drug Administration (FDA) has issued the following safety alerts.
FDA Safety Alerts
These Food and Drug Administration (FDA) developments recently came in.
FDA Safety Alert: Medtronic Issues Recall
The Food and Drug Administration (FDA) has announced a recall of specific models and lots of the Medtronic Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface, as well as perfusion tubing packs containing them, due to potentially high levels of endotoxins.
Medical Device Recall Alert: ACIST Kodama Intravascular Ultrasound Catheter
The Food and Drug Administration (FDA) has announced a recall of certain lots of the ACIST Kodama Intravascular Ultrasound Catheter due to risk of broken O-ring pieces flushing into arteries during use.
USPSTF Issues Draft Recommendation on Screening for Prediabetes and Type 2 Diabetes
The United States Preventive Services Task Force (USPSTF) has released a new draft recommendation statement on screening for prediabetes and type 2 diabetes mellitus. The draft statement includes a new recommendation for screening for prediabetes and type 2 diabetes in adults aged 35 to 70 years who are overweight or obese. The USPSTF also now recommends that clinic…
FDA Safety Alerts
The Food and Drug Administration (FDA) recently posted the following safety alerts.
ACG Updates Guidance on Colorectal Cancer Screening
The American College of Gastroenterology (ACG) has released an updated clinical guideline for colorectal cancer (CRC) screening.
FDA Safety Alert: Spironolactone Tablets
The Food and Drug Administration (FDA) has announced a recall of specific lots of spironolactone (Bryant Ranch Prepack) tablets due to mislabeling; affected product labels may display the incorrect strength. Prepackaged bottles labeled spironolactone 50 mg may contain spironolactone 25 mg tablets and prepackaged bottles of spironolactone 25 mg may contain spironolactone 50 mg…
USPSTF Updates Lung Cancer Screening Guidelines
The United States Preventive Services Task Force (USPSTF) has issued an updated recommendation statement on screening for lung cancer. The USPSTF has modified the age range and smoking history recommended for screening.