Devices

Prenosis AI Sepsis Predictor Authorized for Use

FDA has granted Prenosis a de novo marketing authorization for its Sepsis ImmunoScore artificial intelligence (AI)/machine learning software as a medical device to guide rapid diagnosis and prediction of sepsis. The company says this is the first authorization of an AI diagnostic tool for sepsis, a “complex condition that is difficult to diagnose early and has been a decades-long challenge for the U.S. healthcare system… Even if someone with sepsis survives an episode, the disease can have catastrophic and often permanent consequences on their quality of life after discharge.”

The device uses a combination of biomarkers and clinical data through AI to aid in the risk assessment for presence of or progression to sepsis within 24 hours of patient diagnosis in an emergency department or hospital, according to the company. “By leveraging 22 diverse parameters, the Sepsis ImmunoScore holistically evaluates the patient’s biological status to output a risk score and four discrete risk categories; it is not an alert system,” it says. “These risk categories correlate to a patient’s risk of deterioration, represented by length of stay in the hospital, in-hospital mortality, and escalation of care within 24 hours (ICU admission, mechanical ventilation placement, and/or vasopressor use).”

Additionally, Prenosis says the device’s software is integrated directly into hospital electronic medical records to make results easily accessible to clinicians. “An intuitive display reveals how each of the individual patient’s parameters was used to calculate their final sepsis score,” it says. “This transparent look into the model is critical to build trust and intuition with clinicians and to enable a true clinician-AI partnership, which facilitates faster treatment decisions, improved outcomes, quality metrics, and better hospital financials.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome