We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies. Cookie Policy.

Features Partner Sites Information LinkXpress
Sign In
Advertise with Us
Detecto

Cytovale

Cytovale is a medical diagnostics company focused on providing a more rapid and insightful way to diagnose fast-movin... read more Featured Products: More products

Download Mobile App




Events

ATTENTION: Due to the COVID-19 PANDEMIC, many events are being rescheduled for a later date, converted into virtual venues, or altogether cancelled. Please check with the event organizer or website prior to planning for any forthcoming event.
16 Feb 2023 - 18 Feb 2023

FDA Cleared Sepsis Test Becomes First in New Class of ED-Focused Diagnostic Tools

By HospiMedica International staff writers
Posted on 23 Jan 2023
Print article
Image: The 10-minute IntelliSep sepsis test (Photo courtesy of Cytovale)
Image: The 10-minute IntelliSep sepsis test (Photo courtesy of Cytovale)

Sepsis is a leading cause of death across the world and causes over 270,000 deaths annually in the U.S. It is caused by the body’s overwhelming life-threatening response to an infection, which triggers a chain reaction and rapidly leads to tissue damage, organ failure, and death. If sepsis remains untreated, the risk of death from the condition increases by 8% every hour. Almost 80% of sepsis deaths can be prevented with rapid diagnosis and treatment - making early detection vital to improving clinical, operational, and financial outcomes. Now, a new test has received U.S. Food and Drug Administration (FDA) 510(k) clearance to aid in the early detection of sepsis for the 30 million adult patients who present to US emergency departments (ED) annually with signs and symptoms of the infection.

Cytovale’s (San Francisco, CA, USA) IntelliSep sepsis test is the first FDA-cleared diagnostic tool to assess cellular host response to aid in identifying ED patients with sepsis and contribute to rapid life-saving decisions. The groundbreaking diagnostic tool provides test results in less than 10 minutes, helping clinicians to recognize sepsis and supporting critical time-sensitive clinical decisions. The first in a new class of ED-focused diagnostic tools that assess host response, the IntelliSep sepsis test is a simple, fast, and intuitive solution that provides actionable answers directly from a standard blood draw.

IntelliSep’s innovative technology, which is run on the Cytovale System, assesses the body’s immune response to an infection using immune cell morphology. The biophysical properties of white blood cells from septic patients demonstrate distinct changes when subjected to pressure that are captured in images and then characterized using a proprietary algorithm to produce a result. By applying pressure to tens of thousands of cells and observing their reaction, IntelliSep provides valuable new insights related to sepsis.

IntelliSep categorizes patients into three bands depending on their probability of sepsis, with Band 1 indicating a low probability of sepsis and Band 3 indicating a high probability of sepsis. The results can equip providers with a tool to optimize clinical outcomes and empower hospitals to improve resource utilization and achieve operational excellence. IntelliSep can also support hospital efforts to meet guidelines set by the Centers for Medicare & Medicaid Services (CMS) for timely sepsis treatment, known as SEP-1.

“This clearance is a pivotal step forward in Cytovale’s commitment to early detection technologies to improve health," said Cytovale co-founder and CEO Ajay Shah. "Every minute is crucial in identifying sepsis, and IntelliSep has the potential to transform clinical approaches to sepsis triage and diagnosis and save countless lives."

Related Links:
Cytovale 

Gold Supplier
SBRT Phantom with Removable Spine
E2E SBRT Phantom with Removable Spine Model 036S-CVXX-xx
New
Mobile Radiography System
NeuVision 550M (Plus)
New
X-Ray Image Acquisition Software
dicomPACS DX-R
New
Ultrasound System
HERA W10 Elite

Print article

Channels

AI

view channel
Image: A novel research study moves the needle on predicting coronary artery disease (Photo courtesy of Pexels)

AI-Enabled ECG Analysis Predicts Heart Attack Risk Nearly as well as CT Scans

Increased coronary artery calcium is a marker of coronary artery disease that can lead to a heart attack. Traditionally, CT scans are used to diagnose buildup of coronary artery calcium, although CT scanners... Read more

Critical Care

view channel
Image: The new biomaterial heals tissues from the inside out (Photo courtesy of UC San Diego)

Groundbreaking Biomaterial Injected Intravenously Repairs Cells and Tissue Damaged by Heart Attack and TBI

Following a heart attack, there is development of scar tissue, which affects muscle function and can result in congestive heart failure. However, there is still no established treatment available for repairing... Read more

Surgical Techniques

view channel
Image: The neuro-chip with soft implantable electrodes could manage brain disorders (Photo courtesy of EPFL)

Implantable Neuro-Chip Uses Machine Learning Algorithm to Detect and Treat Neurological Disorders

Using a combination of low-power chip design, machine learning algorithms, and soft implantable electrodes, researchers have produced a neural interface that can identify and suppress symptoms of different... Read more

Health IT

view channel
Image: Using digital data can improve health outcomes (Photo courtesy of Unsplash)

Electronic Health Records May Be Key to Improving Patient Care, Study Finds

When a patient gets transferred from a hospital to a nearby specialist or rehabilitation facility, it is often difficult for personnel at the new facility to access the patient’s electronic health records... Read more

Business

view channel
Image: The global patient positioning systems market is projected to reach USD 1.7 billion by 2027 (Photo courtesy of Pexels)

Global Patient Positioning Systems Market Driven by Increasing Chronic Diseases

The global patient positioning systems market is projected to grow at a CAGR of 4% from USD 1.4 billion in 2022 to USD 1.7 billion by 2027, driven by increasing technological advancements in medical devices,... Read more
Copyright © 2000-2023 Globetech Media. All rights reserved.